<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015181</url>
  </required_header>
  <id_info>
    <org_study_id>170030</org_study_id>
    <secondary_id>17-I-0030</secondary_id>
    <nct_id>NCT03015181</nct_id>
  </id_info>
  <brief_title>VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults</brief_title>
  <official_title>VRC 605: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to&#xD;
      fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent&#xD;
      mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat&#xD;
      HIV-1 infected people.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy&#xD;
      adults.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy people ages 18-50&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with:&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Blood and urine tests&#xD;
&#xD;
      Participants will be assigned to 1 of 7 groups:&#xD;
&#xD;
      Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.&#xD;
&#xD;
      Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48&#xD;
      weeks.&#xD;
&#xD;
      Participants will get the drug in 1 of 2 ways:&#xD;
&#xD;
      Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6&#xD;
      hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will&#xD;
      have 4-5 visits in the week after their second and third doses.&#xD;
&#xD;
      Injection into the fatty tissue under the skin. Participants will have blood tests before the&#xD;
      injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits&#xD;
      after the second and third doses.&#xD;
&#xD;
      Visits include:&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Blood and urine tests&#xD;
&#xD;
      Optional oral swabs to collect saliva&#xD;
&#xD;
      Participants will keep a diary of their temperature and symptoms for 3 days after each dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is the first study of the VRC-HIVMAB075-00-AB (VRC07-523LS) monoclonal antibody (MAb) in&#xD;
      healthy adults. It is a phase 1, dose-escalation study to examine safety, tolerability, dose,&#xD;
      and pharmacokinetics of VRC07-523LS. The hypothesis is that VRC07-523LS will be safe for&#xD;
      administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes.&#xD;
&#xD;
      Healthy adults 18-50 years of age will be enrolled. There are 4 open-label, dose escalations&#xD;
      of VRC07-523LS from 1 mg/kg IV to 40 mg/kg IV, 1 route escalation from IV to SC, and 2&#xD;
      open-label groups to assess repeat dosing. Groups 1-5 are expected to include 3 subjects and&#xD;
      Groups 6-7 are expected to enroll 5 subjects. Subjects will be followed for 24 weeks after&#xD;
      the last study product administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">July 10, 2018</completion_date>
  <primary_completion_date type="Actual">July 10, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration</measure>
    <time_frame>3 days after each product administration</time_frame>
    <description>Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for &quot;Any Systemic Symptom&quot; is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration</measure>
    <time_frame>7 days after each product administration</time_frame>
    <description>Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for &quot;Any Local Symptom&quot; is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events</measure>
    <time_frame>Through 24 weeks after the last product administration</time_frame>
    <description>Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Reporting Serious Adverse Events</measure>
    <time_frame>Through 24 weeks after the last product administration</time_frame>
    <description>Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups</measure>
    <time_frame>Up to 24 weeks post product administration</time_frame>
    <description>Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups</measure>
    <time_frame>Through 24 weeks after the last product administration</time_frame>
    <description>Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.&#xD;
Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:&#xD;
Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS</measure>
    <time_frame>Through 24 weeks after the last product administration for Groups 1-5 and through 8 weeks after the last product administration for Groups 6 and 7</time_frame>
    <description>Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>4 Week Mean Serum Concentration of VRC07-523LS</measure>
    <time_frame>Week 4 post product administration</time_frame>
    <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups</measure>
    <time_frame>Week 12 post product administration</time_frame>
    <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups</measure>
    <time_frame>Up to 12 weeks after each product administration</time_frame>
    <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC(0-inf)): Single Dose Groups</measure>
    <time_frame>Administration (0h) to 24 weeks post product administration</time_frame>
    <description>The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC0-84D): Multiple Dose Groups</measure>
    <time_frame>Administration (0h) up to 84 days after each product administration</time_frame>
    <description>The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group.&#xD;
Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:&#xD;
Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VRC07-523LS Clearance Rate</measure>
    <time_frame>Administration (0h) to 28 days post product administration</time_frame>
    <description>Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall IV Half-life (T1/2) of VRC07-523LS</measure>
    <time_frame>Administration (0h) to 56 days post product administration</time_frame>
    <description>Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS</measure>
    <time_frame>Weeks 4 and 8 post product administration</time_frame>
    <description>Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS</measure>
    <time_frame>Weeks 4, 28 and 32 after the first product administration</time_frame>
    <description>Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>HIV Prevention</condition>
  <arm_group>
    <arm_group_label>Group 1: 1 mg/kg IV Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: 5 mg/kg IV Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: 5 mg/kg SC Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: 20 mg/kg IV Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: 40 mg/kg IV Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6: 5 mg/kg SC Multiple Doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 7: 20 mg/kg IV Multiple Doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VRC-HIVMAB075-00-AB</intervention_name>
    <description>VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
    <arm_group_label>Group 1: 1 mg/kg IV Single Dose</arm_group_label>
    <arm_group_label>Group 2: 5 mg/kg IV Single Dose</arm_group_label>
    <arm_group_label>Group 3: 5 mg/kg SC Single Dose</arm_group_label>
    <arm_group_label>Group 4: 20 mg/kg IV Single Dose</arm_group_label>
    <arm_group_label>Group 5: 40 mg/kg IV Single Dose</arm_group_label>
    <arm_group_label>Group 6: 5 mg/kg SC Multiple Doses</arm_group_label>
    <arm_group_label>Group 7: 20 mg/kg IV Multiple Doses</arm_group_label>
    <other_name>VRC07-523LS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        A volunteer must meet all of the following criteria:&#xD;
&#xD;
          -  Able and willing to complete the informed consent process.&#xD;
&#xD;
          -  18 to 50 years of age.&#xD;
&#xD;
          -  Based on history and examination, must be in good general health and without history&#xD;
             of any of the conditions listed in the exclusion criteria.&#xD;
&#xD;
          -  Willing to have blood samples collected, stored indefinitely, and used for research&#xD;
             purposes.&#xD;
&#xD;
          -  Able to provide proof of identity to the satisfaction of the study clinician&#xD;
             completing the enrollment process.&#xD;
&#xD;
          -  Willing to adhere to reduced risk sexual behavior during study participation.&#xD;
&#xD;
          -  Screening laboratory values within 84 days prior to enrollment must meet the following&#xD;
             criteria:&#xD;
&#xD;
               -  White Blood Cell (WBC) 2,500-12,000/mm^3.&#xD;
&#xD;
               -  WBC differential either within institutional normal range or accompanied by the&#xD;
                  Principal Investigator (PI) or designee approval.&#xD;
&#xD;
               -  Platelets = 125,000 - 400,000/mm^3.&#xD;
&#xD;
               -  Hemoglobin within institutional normal range.&#xD;
&#xD;
               -  Creatinine less than or equal to 1.1 x upper limit of normal (ULN).&#xD;
&#xD;
               -  Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN.&#xD;
&#xD;
          -  Negative for HIV infection by the FDA approved method of detection.&#xD;
&#xD;
          -  Female-Specific Criteria:&#xD;
&#xD;
               -  If a woman is of reproductive potential and sexually active with a male partner,&#xD;
                  then she agrees to use an effective means of birth control from the time of study&#xD;
                  enrollment until the last study visit, or to be monogamous with a partner who has&#xD;
                  had a vasectomy.&#xD;
&#xD;
               -  Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum)&#xD;
                  on day of enrollment for women presumed to be of reproductive potential.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        A volunteer will be excluded if one or more of the following conditions apply:&#xD;
&#xD;
          -  Previous receipt of licensed or investigational monoclonal antibody.&#xD;
&#xD;
          -  Weight &gt;115 kg.&#xD;
&#xD;
          -  Any history of a severe allergic reaction with generalized urticaria, angioedema or&#xD;
             anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the&#xD;
             study.&#xD;
&#xD;
          -  Hypertension that is not well controlled.&#xD;
&#xD;
          -  Woman who is breast-feeding, or planning to become pregnant during the study&#xD;
             participation.&#xD;
&#xD;
          -  Receipt of any investigational study agent within 28 days prior to enrollment.&#xD;
&#xD;
          -  Any other chronic or clinically significant medical condition that in the opinion of&#xD;
             the investigator would jeopardize the safety or rights of the volunteer, including but&#xD;
             not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant&#xD;
             forms of: drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders,&#xD;
             heart disease, or cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin R Gaudinski, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rudicell RS, Kwon YD, Ko SY, Pegu A, Louder MK, Georgiev IS, Wu X, Zhu J, Boyington JC, Chen X, Shi W, Yang ZY, Doria-Rose NA, McKee K, O'Dell S, Schmidt SD, Chuang GY, Druz A, Soto C, Yang Y, Zhang B, Zhou T, Todd JP, Lloyd KE, Eudailey J, Roberts KE, Donald BR, Bailer RT, Ledgerwood J; NISC Comparative Sequencing Program; Mullikin JC, Shapiro L, Koup RA, Graham BS, Nason MC, Connors M, Haynes BF, Rao SS, Roederer M, Kwong PD, Mascola JR, Nabel GJ. Enhanced potency of a broadly neutralizing HIV-1 antibody in vitro improves protection against lentiviral infection in vivo. J Virol. 2014 Nov;88(21):12669-82. doi: 10.1128/JVI.02213-14. Epub 2014 Aug 20.</citation>
    <PMID>25142607</PMID>
  </reference>
  <reference>
    <citation>Wu X, Yang ZY, Li Y, Hogerkorp CM, Schief WR, Seaman MS, Zhou T, Schmidt SD, Wu L, Xu L, Longo NS, McKee K, O'Dell S, Louder MK, Wycuff DL, Feng Y, Nason M, Doria-Rose N, Connors M, Kwong PD, Roederer M, Wyatt RT, Nabel GJ, Mascola JR. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science. 2010 Aug 13;329(5993):856-61. doi: 10.1126/science.1187659. Epub 2010 Jul 8.</citation>
    <PMID>20616233</PMID>
  </reference>
  <results_reference>
    <citation>Gaudinski MR, Houser KV, Doria-Rose NA, Chen GL, Rothwell RSS, Berkowitz N, Costner P, Holman LA, Gordon IJ, Hendel CS, Kaltovich F, Conan-Cibotti M, Gomez Lorenzo M, Carter C, Sitar S, Carlton K, Gall J, Laurencot C, Lin BC, Bailer RT, McDermott AB, Ko SY, Pegu A, Kwon YD, Kwong PD, Namboodiri AM, Pandey JP, Schwartz R, Arnold F, Hu Z, Zhang L, Huang Y, Koup RA, Capparelli EV, Graham BS, Mascola JR, Ledgerwood JE; VRC 605 study team. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial. Lancet HIV. 2019 Oct;6(10):e667-e679. doi: 10.1016/S2352-3018(19)30181-X. Epub 2019 Aug 28.</citation>
    <PMID>31473167</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>June 3, 2019</results_first_submitted>
  <results_first_submitted_qc>July 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 11, 2019</results_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Broadly Neutralizing</keyword>
  <keyword>HIV Prevention</keyword>
  <keyword>Anti-Drug Antibody</keyword>
  <keyword>HIV-1</keyword>
  <keyword>Immune Response</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03015181/Prot_SAP_ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: 1 mg/kg IV Single Dose</title>
          <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: 5 mg/kg IV Single Dose</title>
          <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="P3">
          <title>Group 3: 5 mg/kg SC Single Dose</title>
          <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="P4">
          <title>Group 4: 20 mg/kg IV Single Dose</title>
          <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="P5">
          <title>Group 5: 40 mg/kg IV Single Dose</title>
          <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="P6">
          <title>Group 6: 5 mg/kg SC Multiple Doses</title>
          <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="P7">
          <title>Group 7: 20 mg/kg IV Multiple Doses</title>
          <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received VRC07-523LS Per Protocol</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Discontinued VRC07-523LS Administrations</title>
              <participants_list>
                <participants group_id="P1" count="1">One Group 1 subject decided not to receive the VRC07-523LS infusion</participants>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1">One Group 6 subject received only 1 of 3 scheduled doses prior to withdrawing from the study</participants>
                <participants group_id="P7" count="1">One Group 7 subject received only 1 of 3 scheduled doses due to an unrelated intercurrent illness</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="4">Group 6 subject who received only 1 dose chose to withdraw from study after the first administration</participants>
                <participants group_id="P7" count="4">Group 7 subject who received only 1 dose was withdrawn after unrelated intercurrent illness resolved</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Enrolled, but product never administered</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Population includes all enrolled subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: 1 mg/kg IV Single Dose</title>
          <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: 5 mg/kg IV Single Dose</title>
          <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="B3">
          <title>Group 3: 5 mg/kg SC Single Dose</title>
          <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="B4">
          <title>Group 4: 20 mg/kg IV Single Dose</title>
          <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="B5">
          <title>Group 5: 40 mg/kg IV Single Dose</title>
          <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="B6">
          <title>Group 6: 5 mg/kg SC Multiple Doses</title>
          <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="B7">
          <title>Group 7: 20 mg/kg IV Multiple Doses</title>
          <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="B8">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="5"/>
            <count group_id="B7" value="5"/>
            <count group_id="B8" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.5" spread="7.0"/>
                    <measurement group_id="B2" value="28.0" spread="9.5"/>
                    <measurement group_id="B3" value="30.0" spread="7.0"/>
                    <measurement group_id="B4" value="27.0" spread="2.6"/>
                    <measurement group_id="B5" value="40.0" spread="10.4"/>
                    <measurement group_id="B6" value="25.8" spread="4.1"/>
                    <measurement group_id="B7" value="30.0" spread="10.6"/>
                    <measurement group_id="B8" value="29.2" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>21-30 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>31-40 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>41-50 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiracial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.8" spread="4.6"/>
                    <measurement group_id="B2" value="65.5" spread="17.3"/>
                    <measurement group_id="B3" value="89.4" spread="15.0"/>
                    <measurement group_id="B4" value="75.9" spread="11.0"/>
                    <measurement group_id="B5" value="67.2" spread="20.1"/>
                    <measurement group_id="B6" value="55.2" spread="7.1"/>
                    <measurement group_id="B7" value="76.1" spread="11.4"/>
                    <measurement group_id="B8" value="71.3" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>High school graduate/GeneralEducationalDevelopment</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College/University</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Advanced degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration</title>
        <description>Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for &quot;Any Systemic Symptom&quot; is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.</description>
        <time_frame>3 days after each product administration</time_frame>
        <population>Subjects who received VRC07-523LS (N=25), where &quot;N&quot; signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 7: 20 mg/kg IV Multiple Doses: Dose 1</title>
            <description>Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O6">
            <title>Group 7: 20 mg/kg IV Multiple Doses: Dose 2</title>
            <description>Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O7">
            <title>Group 7: 20 mg/kg IV Multiple Doses: Dose 3</title>
            <description>Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O8">
            <title>Overall IV Groups</title>
            <description>Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups</description>
          </group>
          <group group_id="O9">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O10">
            <title>Group 6: 5 mg/kg SC Multiple Doses: Dose 1</title>
            <description>Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O11">
            <title>Group 6: 5 mg/kg SC Multiple Doses: Dose 2</title>
            <description>Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O12">
            <title>Group 6: 5 mg/kg SC Multiple Doses: Dose 3</title>
            <description>Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O13">
            <title>Overall SC Groups</title>
            <description>Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration</title>
          <description>Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for &quot;Any Systemic Symptom&quot; is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.</description>
          <population>Subjects who received VRC07-523LS (N=25), where &quot;N&quot; signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="17"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="4"/>
                <count group_id="O12" value="4"/>
                <count group_id="O13" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="14"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="14"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="15"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="15"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="16"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="16"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint Pain</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="15"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic Symptom Reported</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="13"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="4"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration</title>
        <description>Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for &quot;Any Local Symptom&quot; is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.</description>
        <time_frame>7 days after each product administration</time_frame>
        <population>Subjects who received VRC07-523LS (N=25), where &quot;N&quot; signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 7: 20 mg/kg IV Multiple Doses: Dose 1</title>
            <description>Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O6">
            <title>Group 7: 20 mg/kg IV Multiple Doses: Dose 2</title>
            <description>Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O7">
            <title>Group 7: 20 mg/kg IV Multiple Doses: Dose 3</title>
            <description>Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O8">
            <title>Overall IV Groups</title>
            <description>Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups</description>
          </group>
          <group group_id="O9">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O10">
            <title>Group 6: 5 mg/kg SC Multiple Doses: Dose 1</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O11">
            <title>Group 6: 5 mg/kg SC Multiple Doses: Dose 2</title>
            <description>Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O12">
            <title>Group 6: 5 mg/kg SC Multiple Doses: Dose 3</title>
            <description>Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O13">
            <title>Overall SC Groups</title>
            <description>Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration</title>
          <description>Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for &quot;Any Local Symptom&quot; is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.</description>
          <population>Subjects who received VRC07-523LS (N=25), where &quot;N&quot; signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="17"/>
                <count group_id="O9" value="3"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="4"/>
                <count group_id="O12" value="4"/>
                <count group_id="O13" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain/Tenderness</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="16"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="2"/>
                    <measurement group_id="O13" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="2"/>
                    <measurement group_id="O13" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="16"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="17"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="17"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="3"/>
                    <measurement group_id="O13" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pruritus</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="17"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="5"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="4"/>
                    <measurement group_id="O13" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Local Symptom Reported</title>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="15"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="3"/>
                    <measurement group_id="O12" value="2"/>
                    <measurement group_id="O13" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="1"/>
                    <measurement group_id="O13" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events</title>
        <description>Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity.</description>
        <time_frame>Through 24 weeks after the last product administration</time_frame>
        <population>Subjects who received VRC07-523LS (N=25), where &quot;N&quot; signifies number of subjects analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O6">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O7">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O8">
            <title>Overall</title>
            <description>Total number of subjects who received VRC07-523LS (VRC-HIVMAB075-00-AB)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events</title>
          <description>Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity.</description>
          <population>Subjects who received VRC07-523LS (N=25), where &quot;N&quot; signifies number of subjects analyzed for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related to study product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unrelated to study product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Serious Adverse Events</title>
        <description>Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration.</description>
        <time_frame>Through 24 weeks after the last product administration</time_frame>
        <population>Subjects who received VRC07-523LS (N=25), where &quot;N&quot; signifies number of subjects analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O6">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O7">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O8">
            <title>Overall</title>
            <description>Total number of subjects who received VRC07-523LS (VRC-HIVMAB075-00-AB)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Serious Adverse Events</title>
          <description>Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration.</description>
          <population>Subjects who received VRC07-523LS (N=25), where &quot;N&quot; signifies number of subjects analyzed for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related to study product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unrelated to study product</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups</title>
        <description>Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection</description>
        <time_frame>Up to 24 weeks post product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups</title>
          <description>Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="16"/>
                    <measurement group_id="O2" value="240" spread="35"/>
                    <measurement group_id="O3" value="50" spread="11"/>
                    <measurement group_id="O4" value="869" spread="190"/>
                    <measurement group_id="O5" value="1630" spread="644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups</title>
        <description>Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.&#xD;
Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:&#xD;
Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion</description>
        <time_frame>Through 24 weeks after the last product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups</title>
          <description>Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.&#xD;
Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:&#xD;
Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" spread="17"/>
                    <measurement group_id="O2" value="1196" spread="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" spread="12"/>
                    <measurement group_id="O2" value="799" spread="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS</title>
        <description>Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion</description>
        <time_frame>Through 24 weeks after the last product administration for Groups 1-5 and through 8 weeks after the last product administration for Groups 6 and 7</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O6">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O7">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS</title>
          <description>Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.5"/>
                    <measurement group_id="O2" value="0.04" spread="0.02"/>
                    <measurement group_id="O3" value="10" spread="9.5"/>
                    <measurement group_id="O4" value="0.3" spread="0.4"/>
                    <measurement group_id="O5" value="0.04" spread="0.02"/>
                    <measurement group_id="O6" value="5.7" spread="5.0"/>
                    <measurement group_id="O7" value="0.04" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>4 Week Mean Serum Concentration of VRC07-523LS</title>
        <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
        <time_frame>Week 4 post product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O6">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O7">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>4 Week Mean Serum Concentration of VRC07-523LS</title>
          <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="5"/>
                <count group_id="O7" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="7.5"/>
                    <measurement group_id="O2" value="57" spread="11"/>
                    <measurement group_id="O3" value="31" spread="11"/>
                    <measurement group_id="O4" value="148" spread="28"/>
                    <measurement group_id="O5" value="272" spread="52"/>
                    <measurement group_id="O6" value="25" spread="13"/>
                    <measurement group_id="O7" value="242" spread="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups</title>
        <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
        <time_frame>Week 12 post product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups</title>
          <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.7"/>
                    <measurement group_id="O2" value="57" spread="11"/>
                    <measurement group_id="O3" value="7.1" spread="1.3"/>
                    <measurement group_id="O4" value="44" spread="14"/>
                    <measurement group_id="O5" value="85" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups</title>
        <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
        <time_frame>Up to 12 weeks after each product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups</title>
          <description>The mean of individual subject VRC07-523LS serum concentrations by administered dose group</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="1.5"/>
                    <measurement group_id="O2" value="46" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="2.5"/>
                    <measurement group_id="O2" value="71" spread="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve (AUC(0-inf)): Single Dose Groups</title>
        <description>The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection</description>
        <time_frame>Administration (0h) to 24 weeks post product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC(0-inf)): Single Dose Groups</title>
          <description>The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
          <units>µg*d/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1381" spread="325"/>
                    <measurement group_id="O2" value="4551" spread="904"/>
                    <measurement group_id="O3" value="2189" spread="309"/>
                    <measurement group_id="O4" value="13748" spread="1853"/>
                    <measurement group_id="O5" value="25517" spread="5097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve (AUC0-84D): Multiple Dose Groups</title>
        <description>The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group.&#xD;
Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:&#xD;
Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion</description>
        <time_frame>Administration (0h) up to 84 days after each product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, value calculated from 4 subjects per group.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC0-84D): Multiple Dose Groups</title>
          <description>The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group.&#xD;
Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:&#xD;
Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, value calculated from 4 subjects per group.</population>
          <units>µg*d/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1440" spread="563"/>
                    <measurement group_id="O2" value="14760" spread="2646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1671" spread="443"/>
                    <measurement group_id="O2" value="13573" spread="1115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VRC07-523LS Clearance Rate</title>
        <description>Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion</description>
        <time_frame>Administration (0h) to 28 days post product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). Value following SC administration represents CL/F (apparent clearance).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O6">
            <title>Overall IV Groups</title>
            <description>Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups</description>
          </group>
          <group group_id="O7">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O8">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O9">
            <title>Overall SC Groups</title>
            <description>Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups</description>
          </group>
        </group_list>
        <measure>
          <title>VRC07-523LS Clearance Rate</title>
          <description>Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). Value following SC administration represents CL/F (apparent clearance).</population>
          <units>mL/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="17"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" spread="20"/>
                    <measurement group_id="O2" value="78" spread="18"/>
                    <measurement group_id="O3" value="110" spread="19"/>
                    <measurement group_id="O4" value="105" spread="14"/>
                    <measurement group_id="O5" value="101" spread="15"/>
                    <measurement group_id="O6" value="94" spread="22"/>
                    <measurement group_id="O7" value="226" spread="54"/>
                    <measurement group_id="O8" value="158" spread="34"/>
                    <measurement group_id="O9" value="184" spread="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall IV Half-life (T1/2) of VRC07-523LS</title>
        <description>Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion</description>
        <time_frame>Administration (0h) to 56 days post product administration</time_frame>
        <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O6">
            <title>Overall IV Groups</title>
            <description>Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups</description>
          </group>
          <group group_id="O7">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O8">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O9">
            <title>Overall SC Groups</title>
            <description>Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups</description>
          </group>
        </group_list>
        <measure>
          <title>Overall IV Half-life (T1/2) of VRC07-523LS</title>
          <description>Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.&#xD;
Serum was collected at the following time points:&#xD;
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion</description>
          <population>Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="17"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" spread="26"/>
                    <measurement group_id="O2" value="32" spread="1.1"/>
                    <measurement group_id="O3" value="45" spread="5.2"/>
                    <measurement group_id="O4" value="42" spread="5.1"/>
                    <measurement group_id="O5" value="27" spread="1.8"/>
                    <measurement group_id="O6" value="38" spread="12"/>
                    <measurement group_id="O7" value="36" spread="6.7"/>
                    <measurement group_id="O8" value="31" spread="10"/>
                    <measurement group_id="O9" value="33" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS</title>
        <description>Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration</description>
        <time_frame>Weeks 4 and 8 post product administration</time_frame>
        <population>Subjects who received a single dose of VRC07-523LS via SC or IV administration. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: 1 mg/kg IV Single Dose</title>
            <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: 5 mg/kg IV Single Dose</title>
            <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: 5 mg/kg SC Single Dose</title>
            <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: 20 mg/kg IV Single Dose</title>
            <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: 40 mg/kg IV Single Dose</title>
            <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS</title>
          <description>Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration</description>
          <population>Subjects who received a single dose of VRC07-523LS via SC or IV administration. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4: Subjects with Anti-Drug Antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8: Subjects with Anti-Drug Antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS</title>
        <description>Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration</description>
        <time_frame>Weeks 4, 28 and 32 after the first product administration</time_frame>
        <population>Subjects who received multiple doses of VRC07-523LS via SC or IV administration. One subject in Group 7 who only received a single dose was not included in this analysis but was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
        <group_list>
          <group group_id="O1">
            <title>Group 6: 5 mg/kg SC Multiple Doses</title>
            <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
          <group group_id="O2">
            <title>Group 7: 20 mg/kg IV Multiple Doses</title>
            <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS</title>
          <description>Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration</description>
          <population>Subjects who received multiple doses of VRC07-523LS via SC or IV administration. One subject in Group 7 who only received a single dose was not included in this analysis but was analyzed with Group 4 (single dose at 20 mg/kg IV).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4: Subjects with Anti-Drug Antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28: Subjects with Anti-Drug Antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 32: Subjects with Anti-Drug Antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Solicited adverse events (AEs) included systemic AEs reported by subjects at the worst severity through 3 days post any product administration; and local administration site AEs reported for subjects at the worst severity through 7 days post any product administration. Unsolicited AEs were reported from the date of product administration through 56 days thereafter, and new chronic medical conditions and SAEs with onset any time following the date of last product administration through 24 weeks.</time_frame>
      <desc>Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: 1 mg/kg IV Single Dose</title>
          <description>Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="E2">
          <title>Group 2: 5 mg/kg IV Single Dose</title>
          <description>Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="E3">
          <title>Group 4: 20 mg/kg IV Single Dose</title>
          <description>Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="E4">
          <title>Group 5: 40 mg/kg IV Single Dose</title>
          <description>Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="E5">
          <title>Group 7: 20 mg/kg IV Multiple Doses</title>
          <description>Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="E6">
          <title>Group 3: 5 mg/kg SC Single Dose</title>
          <description>Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
        <group group_id="E7">
          <title>Group 6: 5 mg/kg SC Multiple Doses</title>
          <description>Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.&#xD;
VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Administration site pain/tenderness</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Administration site bruise</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Administration site erythema</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Redness</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Temperature (Fever)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Femoroacetabular impingement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Joint Pain</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Martin Gaudinski, MD</name_or_title>
      <organization>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health</organization>
      <phone>301-451-8715</phone>
      <email>martin.gaudinski@nih.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015181
org study id: 170030
secondary id: 17-I-0030
nct id: NCT03015181
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Background:

      Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to
      fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent
      mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat
      HIV-1 infected people.

      Objective:

      To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy
      adults.

      Eligibility:

      Healthy people ages 18-50

      Design:

      Participants will be screened with:

      Medical history

      Physical exam

      Blood and urine tests

      Participants will be assigned to 1 of 7 groups:

      Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.

      Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48
      weeks.

      Participants will get the drug in 1 of 2 ways:

      Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6
      hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will
      have 4-5 visits in the week after their second and third doses.

      Injection into the fatty tissue under the skin. Participants will have blood tests before the
      injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits
      after the second and third doses.

      Visits include:

      Physical exam

      Blood and urine tests

      Optional oral swabs to collect saliva

      Participants will keep a diary of their temperature and symptoms for 3 days after each dose.
This is the first study of the VRC-HIVMAB075-00-AB (VRC07-523LS) monoclonal antibody (MAb) in
      healthy adults. It is a phase 1, dose-escalation study to examine safety, tolerability, dose,
      and pharmacokinetics of VRC07-523LS. The hypothesis is that VRC07-523LS will be safe for
      administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes.

      Healthy adults 18-50 years of age will be enrolled. There are 4 open-label, dose escalations
      of VRC07-523LS from 1 mg/kg IV to 40 mg/kg IV, 1 route escalation from IV to SC, and 2
      open-label groups to assess repeat dosing. Groups 1-5 are expected to include 3 subjects and
      Groups 6-7 are expected to enroll 5 subjects. Subjects will be followed for 24 weeks after
      the last study product administration.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration
time frame: 3 days after each product administration
description: Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.
measure: Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration
time frame: 7 days after each product administration
description: Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.
measure: Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events
time frame: Through 24 weeks after the last product administration
description: Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity.
measure: Number of Subjects Reporting Serious Adverse Events
time frame: Through 24 weeks after the last product administration
description: Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration.
measure: Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups
time frame: Up to 24 weeks post product administration
description: Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Serum was collected at the following time points:
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection
measure: Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups
time frame: Through 24 weeks after the last product administration
description: Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:
Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS
time frame: Through 24 weeks after the last product administration for Groups 1-5 and through 8 weeks after the last product administration for Groups 6 and 7
description: Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group
Serum was collected at the following time points:
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion
measure: 4 Week Mean Serum Concentration of VRC07-523LS
time frame: Week 4 post product administration
description: The mean of individual subject VRC07-523LS serum concentrations by administered dose group
measure: 12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups
time frame: Week 12 post product administration
description: The mean of individual subject VRC07-523LS serum concentrations by administered dose group
measure: 12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups
time frame: Up to 12 weeks after each product administration
description: The mean of individual subject VRC07-523LS serum concentrations by administered dose group
measure: Area Under the Curve (AUC(0-inf)): Single Dose Groups
time frame: Administration (0h) to 24 weeks post product administration
description: The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz.
Serum was collected at the following time points:
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection
measure: Area Under the Curve (AUC0-84D): Multiple Dose Groups
time frame: Administration (0h) up to 84 days after each product administration
description: The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group.
Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:
Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion
measure: VRC07-523LS Clearance Rate
time frame: Administration (0h) to 28 days post product administration
description: Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group.
Serum was collected at the following time points:
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion
measure: Overall IV Half-life (T1/2) of VRC07-523LS
time frame: Administration (0h) to 56 days post product administration
description: Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Serum was collected at the following time points:
Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion
measure: Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS
time frame: Weeks 4 and 8 post product administration
description: Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration
measure: Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS
time frame: Weeks 4, 28 and 32 after the first product administration
description: Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration
arm group label: Group 1: 1 mg/kg IV Single Dose
arm group type: Experimental
description: Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg.
arm group label: Group 2: 5 mg/kg IV Single Dose
arm group type: Experimental
description: Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.
arm group label: Group 3: 5 mg/kg SC Single Dose
arm group type: Experimental
description: Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg.
arm group label: Group 4: 20 mg/kg IV Single Dose
arm group type: Experimental
description: Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg.
arm group label: Group 5: 40 mg/kg IV Single Dose
arm group type: Experimental
description: Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg.
arm group label: Group 6: 5 mg/kg SC Multiple Doses
arm group type: Experimental
description: Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg.
arm group label: Group 7: 20 mg/kg IV Multiple Doses
arm group type: Experimental
description: Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg.
intervention type: Biological
intervention name: VRC-HIVMAB075-00-AB
description: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
arm group label: Group 1: 1 mg/kg IV Single Dose
arm group label: Group 2: 5 mg/kg IV Single Dose
arm group label: Group 3: 5 mg/kg SC Single Dose
arm group label: Group 4: 20 mg/kg IV Single Dose
arm group label: Group 5: 40 mg/kg IV Single Dose
arm group label: Group 6: 5 mg/kg SC Multiple Doses
arm group label: Group 7: 20 mg/kg IV Multiple Doses
other name: VRC07-523LS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Martin R Gaudinski, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
country: United States
citation: Rudicell RS, Kwon YD, Ko SY, Pegu A, Louder MK, Georgiev IS, Wu X, Zhu J, Boyington JC, Chen X, Shi W, Yang ZY, Doria-Rose NA, McKee K, O'Dell S, Schmidt SD, Chuang GY, Druz A, Soto C, Yang Y, Zhang B, Zhou T, Todd JP, Lloyd KE, Eudailey J, Roberts KE, Donald BR, Bailer RT, Ledgerwood J; NISC Comparative Sequencing Program; Mullikin JC, Shapiro L, Koup RA, Graham BS, Nason MC, Connors M, Haynes BF, Rao SS, Roederer M, Kwong PD, Mascola JR, Nabel GJ. Enhanced potency of a broadly neutralizing HIV-1 antibody in vitro improves protection against lentiviral infection in vivo. J Virol. 2014 Nov;88(21):12669-82. doi: 10.1128/JVI.02213-14. Epub 2014 Aug 20.
PMID: 25142607
citation: Wu X, Yang ZY, Li Y, Hogerkorp CM, Schief WR, Seaman MS, Zhou T, Schmidt SD, Wu L, Xu L, Longo NS, McKee K, O'Dell S, Louder MK, Wycuff DL, Feng Y, Nason M, Doria-Rose N, Connors M, Kwong PD, Roederer M, Wyatt RT, Nabel GJ, Mascola JR. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science. 2010 Aug 13;329(5993):856-61. doi: 10.1126/science.1187659. Epub 2010 Jul 8.
PMID: 20616233
citation: Gaudinski MR, Houser KV, Doria-Rose NA, Chen GL, Rothwell RSS, Berkowitz N, Costner P, Holman LA, Gordon IJ, Hendel CS, Kaltovich F, Conan-Cibotti M, Gomez Lorenzo M, Carter C, Sitar S, Carlton K, Gall J, Laurencot C, Lin BC, Bailer RT, McDermott AB, Ko SY, Pegu A, Kwon YD, Kwong PD, Namboodiri AM, Pandey JP, Schwartz R, Arnold F, Hu Z, Zhang L, Huang Y, Koup RA, Capparelli EV, Graham BS, Mascola JR, Ledgerwood JE; VRC 605 study team. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial. Lancet HIV. 2019 Oct;6(10):e667-e679. doi: 10.1016/S2352-3018(19)30181-X. Epub 2019 Aug 28.
PMID: 31473167
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 