<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/NCT02985996</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00092488</org_study_id>
    <nct_id>NCT02985996</nct_id>
  </id_info>
  <brief_title>Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities</brief_title>
  <official_title>Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</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>
      The purpose of this study is to determine the ability of new anti-HIV agents to penetrate&#xD;
      different body compartments in HIV negative men who have sex with men and transgender women.&#xD;
      These new agents might be considered for pre-exposure prophylaxis regimens in the future.&#xD;
      This study will include 90 healthy, HIV-negative men who have sex with men and transgender&#xD;
      women who are not taking hormones aged 18-49 years. Participant must be willing to&#xD;
      participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and&#xD;
      willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Men who have sex with men (MSM) and Transgender women (TGW) who have sex with men continue to&#xD;
      be disproportionately affected by HIV. Over 60% of new HIV infections in the US occur among&#xD;
      MSM. The majority of HIV infections among MSM and TGW occur through exposure to the rectal&#xD;
      mucosa during receptive anal intercourse (RAI). Pre-exposure prophylaxis (PrEP) is a new HIV&#xD;
      prevention method that is recommended by CDC and WHO for MSM at risk of HIV infection. PrEP&#xD;
      entails taking an anti-HIV medication (Truvada®; tenofovir/emtricitabine) on a daily basis to&#xD;
      prevent HIV infection. However, current tenofovir- based regimens have shown to have side&#xD;
      effects that researchers are hoping to reduce in newly developed anti-HIV agents. This study&#xD;
      is designed to examine the ability of these new agents to penetrate mucosal tissues and&#xD;
      potentially prevent HIV infection during RAI exposure for MSM and TGW.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Intracellular Tenofovir Diphosphate (TFV-DP)</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma Emtricitabine (FTC) Concentration</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Plasma emtricitabine (FTC) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma Tenofovir Alafenamide (TAF) Concentration</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Plasma tenofovir alafenamide (TAF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Plasma Elvitegravir (EVG) Concentration</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Plasma elvitegravir (EVG) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Rectal Emtricitabine (FTC) Concentration</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Emtricitabine (FTC) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Rectal Tenofovir Alafenamide (TAF) Concentration</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Tenofovir alafenamide (TAF) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Rectal Elvitegravir (EVG) Concentration</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Elvitegravir (EVG) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Intracellular tenofovir alafenamide (TAF) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Intracellular elvitegravir (EVG) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Tissue tenofovir alafenamide (TAF) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Elvitegravir (EVG) Concentration in Rectal Tissue</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Emtricitabine (FTC) Concentration in Penile Secretions</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Emtricitabine (FTC) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Tenofovir alafenamide (TAF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Elvitegravir (EVG) Concentration in Penile Secretions</measure>
    <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
    <description>Elvitegravir (EVG) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV</measure>
    <time_frame>Up to 10 months post-baseline</time_frame>
    <description>Rectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy.&#xD;
For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Phase I/Pre-Drug</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Ten participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase II/Genvoya</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase II/Truvada</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase III/Genvoya</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase III/Truvada</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Truvada</intervention_name>
    <description>Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.</description>
    <arm_group_label>Phase II/Truvada</arm_group_label>
    <arm_group_label>Phase III/Truvada</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Genvoya</intervention_name>
    <description>Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.</description>
    <arm_group_label>Phase II/Genvoya</arm_group_label>
    <arm_group_label>Phase III/Genvoya</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-negative man who reports receptive anal sex with another man in the last 6 months&#xD;
&#xD;
          -  Male to female transgender women who have sex with men who report receptive anal&#xD;
             intercourse with another man in the last 6 months and are not currently taking&#xD;
             hormonal therapy or plan to take hormonal therapy for the duration of the study&#xD;
&#xD;
          -  Not currently taking PrEP and no plans to initiate during study&#xD;
&#xD;
          -  Able to provide informed consent in English&#xD;
&#xD;
          -  No plans for relocation in the next 3 months&#xD;
&#xD;
          -  Willing to undergo peripheral blood and rectal biopsy sampling&#xD;
&#xD;
          -  Willing to use study products as directed&#xD;
&#xD;
          -  Willing to abstain from receptive anal intercourse 3 days prior to starting study&#xD;
             product and for the duration of the study and for 7 days after any rectal biopsy&#xD;
             procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of inflammatory bowel disease or other inflammatory, infiltrative, infectious&#xD;
             or vascular condition involving the lower gastrointestinal tract that, in the judgment&#xD;
             of the investigators, may be worsened by study procedures or may significantly distort&#xD;
             the anatomy of the distal large bowel&#xD;
&#xD;
          -  Significant laboratory abnormalities at baseline visit, including but not limited to:&#xD;
&#xD;
               1. Hgb ≤ 10 g/dL&#xD;
&#xD;
               2. PTT &gt; 1.5x ULN or INR &gt; 1.5x ULN&#xD;
&#xD;
               3. Platelet count &lt;100,000&#xD;
&#xD;
               4. Creatinine clearance &lt;60&#xD;
&#xD;
          -  Any known medical condition that, in the judgment of the investigators, increases the&#xD;
             risk of local or systemic complications of endoscopic procedures or pelvic&#xD;
             examination, including but not limited to:&#xD;
&#xD;
               1. Uncontrolled or severe cardiac arrhythmia&#xD;
&#xD;
               2. Recent major abdominal, cardiothoracic, or neurological surgery&#xD;
&#xD;
               3. History of uncontrolled bleeding diathesis&#xD;
&#xD;
               4. History of colonic, rectal, or vaginal perforation, fistula, or malignancy&#xD;
&#xD;
               5. History or evidence on clinical examination of ulcerative, suppurative, or&#xD;
                  proliferative lesions of the anorectal or vaginal mucosa, or untreated sexually&#xD;
                  transmitted disease with mucosal involvement&#xD;
&#xD;
          -  Continued need for, or use during the 14 days prior to enrollment, of the following&#xD;
             medications:&#xD;
&#xD;
               1. Aspirin or more than 4 doses of NSAIDs&#xD;
&#xD;
               2. Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation&#xD;
                  inhibitors, or fibrinolytic agents&#xD;
&#xD;
               3. Any form of rectally administered agent besides products lubricants or douching&#xD;
                  used for sexual intercourse&#xD;
&#xD;
          -  Continued need for, or use during the 90 days prior to enrollment, of the following&#xD;
             medications:&#xD;
&#xD;
               1. Systemic immunomodulatory agents&#xD;
&#xD;
               2. Supraphysiologic doses of steroids&#xD;
&#xD;
               3. Experimental medications, vaccines, or biologicals&#xD;
&#xD;
          -  Intent to use HIV antiretroviral pre-exposure prophylaxis (PrEP) during the study,&#xD;
             outside of the study procedures&#xD;
&#xD;
          -  Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain,&#xD;
             discharge, bleeding, etc.)&#xD;
&#xD;
          -  Current use of hormonal therapy&#xD;
&#xD;
          -  Any other clinical condition or prior therapy that, in the opinion of the&#xD;
             investigator, would make the patient unsuitable for the study or unable to comply with&#xD;
             the study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colleen Kelley, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>January 22, 2019</results_first_submitted>
  <results_first_submitted_qc>September 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2019</results_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Colleen Kelley</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Preventative Medicine</keyword>
  <keyword>Infectious Diseases</keyword>
  <keyword>Sexually Transmitted Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
    <mesh_term>Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02985996/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02985996/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>24 participants were recruited in Phase II, but only 18 were randomized to either Genvoya or Truvada due to lost to follow up.&#xD;
19 participants were recruited in Phase III, but only 16 were randomized to either Genvoya or Truvada due to lost to follow up.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Phase I/Pre-Drug</title>
          <description>Participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="P2">
          <title>Phase II/Genvoya</title>
          <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="P3">
          <title>Phase II/Truvada</title>
          <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="P4">
          <title>Phase III/Genvoya</title>
          <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="P5">
          <title>Phase III/Truvada</title>
          <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Phase I/Pre-Drug</title>
          <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="B2">
          <title>Phase II/Genvoya</title>
          <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="B3">
          <title>Phase II/Truvada</title>
          <description>Experimental: Phase II/Truvada Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="B4">
          <title>Phase III/Genvoya</title>
          <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="B5">
          <title>Phase III/Truvada</title>
          <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="B6">
          <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="5"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="9"/>
            <count group_id="B6" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 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="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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="0"/>
                    <measurement group_id="B6" value="0"/>
                  </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="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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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_list>
                </category>
                <category>
                  <title>Asian</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_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </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="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)</title>
        <description>Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)</title>
          <description>Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>fmol/1000000 PBMC</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="3380" lower_limit="2091" upper_limit="4320"/>
                    <measurement group_id="O3" value="2580" lower_limit="1531" upper_limit="5340"/>
                    <measurement group_id="O4" value="6470" lower_limit="3030" upper_limit="15,380"/>
                    <measurement group_id="O5" value="7660" lower_limit="3170" upper_limit="10,470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Intracellular Tenofovir Diphosphate (TFV-DP)</title>
        <description>Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Intracellular Tenofovir Diphosphate (TFV-DP)</title>
          <description>Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>fmol/1000000 PBMC</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="213" lower_limit="111" upper_limit="323"/>
                    <measurement group_id="O3" value="28" lower_limit="0" upper_limit="32"/>
                    <measurement group_id="O4" value="453" lower_limit="138" upper_limit="897"/>
                    <measurement group_id="O5" value="80" lower_limit="0" upper_limit="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasma Emtricitabine (FTC) Concentration</title>
        <description>Plasma emtricitabine (FTC) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Emtricitabine (FTC) Concentration</title>
          <description>Plasma emtricitabine (FTC) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="30" lower_limit="12" upper_limit="46"/>
                    <measurement group_id="O3" value="34" lower_limit="20" upper_limit="206"/>
                    <measurement group_id="O4" value="152" lower_limit="31" upper_limit="613"/>
                    <measurement group_id="O5" value="280" lower_limit="66" upper_limit="518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration</title>
        <description>Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Short Course</title>
            <description>Participants will be randomized to receive one dose of Truvada or Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.&#xD;
Truvada: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.&#xD;
Genvoya: Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.</description>
          </group>
          <group group_id="O3">
            <title>Phase III/Steady State</title>
            <description>Participants will be randomized to receive Truvada or Genvoya to be taken once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.&#xD;
Truvada: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.&#xD;
Genvoya: Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration</title>
          <description>Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="28" lower_limit="20" upper_limit="59"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="59" lower_limit="38" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasma Tenofovir Alafenamide (TAF) Concentration</title>
        <description>Plasma tenofovir alafenamide (TAF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <population>TAF was not measured, only the metabolite TFV was measured</population>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Tenofovir Alafenamide (TAF) Concentration</title>
          <description>Plasma tenofovir alafenamide (TAF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <population>TAF was not measured, only the metabolite TFV was measured</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Plasma Elvitegravir (EVG) Concentration</title>
        <description>Plasma elvitegravir (EVG) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Plasma Elvitegravir (EVG) Concentration</title>
          <description>Plasma elvitegravir (EVG) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="102" lower_limit="0" upper_limit="295"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="384" lower_limit="99" upper_limit="705"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Rectal Emtricitabine (FTC) Concentration</title>
        <description>Emtricitabine (FTC) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Rectal Emtricitabine (FTC) Concentration</title>
          <description>Emtricitabine (FTC) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/swab</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="288" lower_limit="0" upper_limit="42,450"/>
                    <measurement group_id="O3" value="419" lower_limit="64" upper_limit="6935"/>
                    <measurement group_id="O4" value="371" lower_limit="0" upper_limit="3830"/>
                    <measurement group_id="O5" value="109" lower_limit="0" upper_limit="3900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration</title>
        <description>Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration</title>
          <description>Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/swab</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="58" lower_limit="0" upper_limit="1195"/>
                    <measurement group_id="O3" value="45" lower_limit="0" upper_limit="263"/>
                    <measurement group_id="O4" value="533" lower_limit="0" upper_limit="18,400"/>
                    <measurement group_id="O5" value="1325" lower_limit="0" upper_limit="6145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Rectal Tenofovir Alafenamide (TAF) Concentration</title>
        <description>Tenofovir alafenamide (TAF) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <population>The study didn't measure TAF, only the metabolite TFV</population>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Rectal Tenofovir Alafenamide (TAF) Concentration</title>
          <description>Tenofovir alafenamide (TAF) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <population>The study didn't measure TAF, only the metabolite TFV</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Rectal Elvitegravir (EVG) Concentration</title>
        <description>Elvitegravir (EVG) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Rectal Elvitegravir (EVG) Concentration</title>
          <description>Elvitegravir (EVG) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/swab</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="405" lower_limit="55" upper_limit="7975"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="219" lower_limit="0" upper_limit="54,100"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)</title>
        <description>Intracellular tenofovir alafenamide (TAF) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <population>The study didn't measure TAF, only the metabolite TFV</population>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)</title>
          <description>Intracellular tenofovir alafenamide (TAF) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <population>The study didn't measure TAF, only the metabolite TFV</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)</title>
        <description>Intracellular elvitegravir (EVG) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <population>EVG is very difficult to measure intracellularly, therefore the study only measured plasma or extracellular concentrations.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)</title>
          <description>Intracellular elvitegravir (EVG) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <population>EVG is very difficult to measure intracellularly, therefore the study only measured plasma or extracellular concentrations.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue</title>
        <description>Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue</title>
          <description>Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>fmol/mg tissue</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="11"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="51"/>
                    <measurement group_id="O4" value="27" lower_limit="0" upper_limit="79"/>
                    <measurement group_id="O5" value="41" lower_limit="0" upper_limit="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue</title>
        <description>Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue</title>
          <description>Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>fmol/mg tissue</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="17" lower_limit="0" upper_limit="65"/>
                    <measurement group_id="O3" value="11" lower_limit="0" upper_limit="74"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="102"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue</title>
        <description>Tissue tenofovir alafenamide (TAF) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <population>The study didn't measure TAF, only the metabolite TFV</population>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue</title>
          <description>Tissue tenofovir alafenamide (TAF) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <population>The study didn't measure TAF, only the metabolite TFV</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Elvitegravir (EVG) Concentration in Rectal Tissue</title>
        <description>Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Elvitegravir (EVG) Concentration in Rectal Tissue</title>
          <description>Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/mg tissue</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="2.7" lower_limit="1.2" upper_limit="9.8"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="6.8" lower_limit="4.5" upper_limit="11.1"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Emtricitabine (FTC) Concentration in Penile Secretions</title>
        <description>Emtricitabine (FTC) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Short Course</title>
            <description>Participants will be randomized to receive one dose of Truvada or Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.&#xD;
Truvada: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.&#xD;
Genvoya: Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.</description>
          </group>
          <group group_id="O3">
            <title>Phase III/Steady State</title>
            <description>Participants will be randomized to receive Truvada or Genvoya to be taken once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.&#xD;
Truvada: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.&#xD;
Genvoya: Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Emtricitabine (FTC) Concentration in Penile Secretions</title>
          <description>Emtricitabine (FTC) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/swab</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="32" lower_limit="0" upper_limit="77"/>
                    <measurement group_id="O3" value="30" lower_limit="0" upper_limit="406"/>
                    <measurement group_id="O4" value="175" lower_limit="0" upper_limit="1775"/>
                    <measurement group_id="O5" value="54" lower_limit="0" upper_limit="9685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions</title>
        <description>Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions</title>
          <description>Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/swab</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="385"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O5" value="17" lower_limit="0" upper_limit="818"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions</title>
        <description>Tenofovir alafenamide (TAF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <population>The study did not measure TAF, only the metabolite TFV</population>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions</title>
          <description>Tenofovir alafenamide (TAF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <population>The study did not measure TAF, only the metabolite TFV</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Elvitegravir (EVG) Concentration in Penile Secretions</title>
        <description>Elvitegravir (EVG) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Baseline, Visit 4 (Up to ten days post drug)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Elvitegravir (EVG) Concentration in Penile Secretions</title>
          <description>Elvitegravir (EVG) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng/swab</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="28"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV</title>
        <description>Rectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy.&#xD;
For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
        <time_frame>Up to 10 months post-baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Phase I/Pre-Drug</title>
            <description>Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O2">
            <title>Phase II/Genvoya</title>
            <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O3">
            <title>Phase II/Truvada</title>
            <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O4">
            <title>Phase III/Genvoya</title>
            <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
          <group group_id="O5">
            <title>Phase III/Truvada</title>
            <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
          </group>
        </group_list>
        <measure>
          <title>PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV</title>
          <description>Rectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy.&#xD;
For the pharmacokinetic analysis, values reported as &quot;Below the Limit of Quantification&quot; (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.</description>
          <units>ng p24</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="740" lower_limit="271" upper_limit="2319"/>
                    <measurement group_id="O2" value="225" lower_limit="128" upper_limit="535"/>
                    <measurement group_id="O3" value="298" lower_limit="224" upper_limit="381"/>
                    <measurement group_id="O4" value="348" lower_limit="159" upper_limit="504"/>
                    <measurement group_id="O5" value="327" lower_limit="94" upper_limit="465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Phase I/Pre-Drug</title>
          <description>Ten participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="E2">
          <title>Phase II/Genvoya</title>
          <description>Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="E3">
          <title>Phase II/Truvada</title>
          <description>Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="E4">
          <title>Phase III/Genvoya</title>
          <description>Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</description>
        </group>
        <group group_id="E5">
          <title>Phase III/Truvada</title>
          <description>Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
              </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>Dr. Colleen Kelley</name_or_title>
      <organization>Emory University</organization>
      <phone>404-712-1823</phone>
      <email>colleen.kelley@emory.edu</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/NCT02985996
org study id: IRB00092488
nct id: NCT02985996
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate
      different body compartments in HIV negative men who have sex with men and transgender women.
      These new agents might be considered for pre-exposure prophylaxis regimens in the future.
      This study will include 90 healthy, HIV-negative men who have sex with men and transgender
      women who are not taking hormones aged 18-49 years. Participant must be willing to
      participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and
      willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
Men who have sex with men (MSM) and Transgender women (TGW) who have sex with men continue to
      be disproportionately affected by HIV. Over 60% of new HIV infections in the US occur among
      MSM. The majority of HIV infections among MSM and TGW occur through exposure to the rectal
      mucosa during receptive anal intercourse (RAI). Pre-exposure prophylaxis (PrEP) is a new HIV
      prevention method that is recommended by CDC and WHO for MSM at risk of HIV infection. PrEP
      entails taking an anti-HIV medication (Truvada®; tenofovir/emtricitabine) on a daily basis to
      prevent HIV infection. However, current tenofovir- based regimens have shown to have side
      effects that researchers are hoping to reduce in newly developed anti-HIV agents. This study
      is designed to examine the ability of these new agents to penetrate mucosal tissues and
      potentially prevent HIV infection during RAI exposure for MSM and TGW.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Changes in Intracellular Tenofovir Diphosphate (TFV-DP)
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Plasma Emtricitabine (FTC) Concentration
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Plasma emtricitabine (FTC) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Plasma Tenofovir Alafenamide (TAF) Concentration
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Plasma tenofovir alafenamide (TAF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Plasma Elvitegravir (EVG) Concentration
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Plasma elvitegravir (EVG) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Rectal Emtricitabine (FTC) Concentration
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Emtricitabine (FTC) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Rectal Tenofovir Alafenamide (TAF) Concentration
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Tenofovir alafenamide (TAF) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Rectal Elvitegravir (EVG) Concentration
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Elvitegravir (EVG) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Intracellular tenofovir alafenamide (TAF) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Intracellular elvitegravir (EVG) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Tissue tenofovir alafenamide (TAF) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Elvitegravir (EVG) Concentration in Rectal Tissue
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Emtricitabine (FTC) Concentration in Penile Secretions
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Emtricitabine (FTC) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Tenofovir alafenamide (TAF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: Change in Elvitegravir (EVG) Concentration in Penile Secretions
time frame: Baseline, Visit 4 (Up to ten days post drug)
description: Elvitegravir (EVG) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
measure: PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV
time frame: Up to 10 months post-baseline
description: Rectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
arm group label: Phase I/Pre-Drug
arm group type: No Intervention
description: Ten participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
arm group label: Phase II/Genvoya
arm group type: Experimental
description: Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
arm group label: Phase II/Truvada
arm group type: Experimental
description: Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
arm group label: Phase III/Genvoya
arm group type: Experimental
description: Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
arm group label: Phase III/Truvada
arm group type: Experimental
description: Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken.
intervention type: Drug
intervention name: Truvada
description: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.
arm group label: Phase II/Truvada
arm group label: Phase III/Truvada
intervention type: Drug
intervention name: Genvoya
description: Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.
arm group label: Phase II/Genvoya
arm group label: Phase III/Genvoya
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: No
last name: Colleen Kelley, MD, MPH
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Colleen Kelley
investigator title: Assistant Professor
mesh term: HIV Infections
mesh term: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
mesh term: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 