<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/NCT03239899</url>
  </required_header>
  <id_info>
    <org_study_id>170145</org_study_id>
    <secondary_id>17-N-0145</secondary_id>
    <nct_id>NCT03239899</nct_id>
  </id_info>
  <brief_title>PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection</brief_title>
  <official_title>PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      HIV affects millions of people. The disease may &quot;hide&quot; in the brain, even in people with&#xD;
      well-controlled HIV without cancer. Then it may &quot;wake up&quot; and continue. The drug&#xD;
      pembrolizumab uses the body s immune system to fight cells like cancer cells. It is approved&#xD;
      to treat some cancers but not HIV. Researchers want to see if it is safe for HIV-positive&#xD;
      people without cancer. This study is not for HIV treatment; only one dose of the drug will be&#xD;
      used.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To learn if the drug pembrolizumab, used to treat certain cancers, is safe for HIV-positive&#xD;
      people.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Adults ages 18 and older with HIV who are in another NIH protocol&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with:&#xD;
&#xD;
        -  Medical history&#xD;
&#xD;
        -  Physical and neurological exams&#xD;
&#xD;
        -  Blood tests&#xD;
&#xD;
        -  Lumbar puncture. The lower back will be numbed. A needle will remove fluid from between&#xD;
           back bones.&#xD;
&#xD;
        -  FDG-PET/CT. A radioactive sugar will be injected in a thin plastic tube (catheter)&#xD;
           inserted in an arm vein. Participants will rest for an hour, urinate, then lie in the&#xD;
           scanner. A mask will hold the head still.&#xD;
&#xD;
        -  Leukapheresis. An optional procedure at baseline. White blood cells are removed from you&#xD;
           using a serum cell separator machine&#xD;
&#xD;
      Women who can become pregnant cannot take pembrolizumab. Men who take it must use 2 kinds of&#xD;
      contraception.&#xD;
&#xD;
      Participants will have up to 7 more visits, which repeat some screening tests.&#xD;
&#xD;
      At 1 visit, participants will get one dose of pembrolizumab by catheter for 30 minutes. They&#xD;
      will get allergy and pain medicines.&#xD;
&#xD;
      At 2 visits, participants will have a brain MRI. They will get a contrast agent by catheter.&#xD;
      They will lie in a metal cylinder that takes pictures for 1-2 hours. They will get earplugs&#xD;
      for loud sounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective&#xD;
&#xD;
      In this Phase I, proof-of-concept study, we aim to determine the safety and tolerability of&#xD;
      pembrolizumab, an FDA-approved monoclonal antibody against programmed cell death protein&#xD;
      (PD)-1, in viremically suppressed human immunodeficiency virus-1 (HIV) positive patients. We&#xD;
      are examining the correlation of immune activation and suppression markers in viremically&#xD;
      suppressed HIV positive patients with the effects of pembrolizumab on immune restoration&#xD;
      function (e.g. CD4 count, HIV viral load) and immune activation (e.g. HIV-specific T-cell&#xD;
      responses).&#xD;
&#xD;
      Study Population&#xD;
&#xD;
      HIV is estimated to infect 37.6 million people globally, with 690,000 deaths and 1.5 million&#xD;
      new infections occurring yearly. There is no cure. Opportunistic infections and neoplasms&#xD;
      contribute to a large portion of mortality and morbidity within the HIV-positive population.&#xD;
      Even in well- controlled, viremically suppressed patients, neurologic complications including&#xD;
      HIV-associated neurocognitive disorder, continue to contribute to disease morbidity and&#xD;
      mortality.&#xD;
&#xD;
      There is evidence that HIV reservoirs contribute to the inability to cure HIV infection. In&#xD;
      the brain, macrophages and astrocytes harbor HIV. It is theorized that the brain is a&#xD;
      potential reservoir for replication competent HIV. PD-1 expression is elevated in patients&#xD;
      with HIV compared to uninfected controls. Upregulated PD-1 expression is associated with&#xD;
      higher viral load and increased mortality in infections.1 PD-1 co-expression on regulatory&#xD;
      T-cells has been shown to correlate with disease progression in perinatally-infected&#xD;
      HIV-positive children. Drugs targeting the PD-1 pathway in HIV infection have shown&#xD;
      upregulation of T-cell responses that are potentially critical to eradication of infection.&#xD;
      Pembrolizumab is an attractive option due to its mechanism of action, although it has been&#xD;
      rarely used in the HIV population.&#xD;
&#xD;
      Design&#xD;
&#xD;
      In this single-center, single-arm, open label, baseline-versus-treatment phase I clinical&#xD;
      trial, twelve patients with HIV-1 infection receive a one-time dose of 200mg pembrolizumab&#xD;
      with a baseline study period of 3 weeks, a one-day treatment phase, and a 6-month post&#xD;
      treatment phase. Outcome measures are collected every 3 to 6 weeks for the duration of the&#xD;
      study.&#xD;
&#xD;
      Outcome Measures&#xD;
&#xD;
      The primary outcome is the safety and tolerability of pembrolizumab, which is measured by&#xD;
      clinical exam, laboratory studies and adverse event tabulations using the Common Terminology&#xD;
      Criteria for Adverse Events (CTCAE) v5.0.&#xD;
&#xD;
      In addition, viral and immunologic outcome measures investigating the impact of pembrolizumab&#xD;
      on HIV-1 biology and its effects on immune function is measured in the CSF and periphery,&#xD;
      including single copy HIV analysis, CD4+ T-cell count, PD-1 lymphocyte expression and T-cell&#xD;
      phenotype analysis, T-cell proliferation against HIV-proteins, CSF cytokine analysis and/or&#xD;
      CSF antibody profiling (LIPS). These additional studies offer indirect proof of a HIV viral&#xD;
      reservoir in the CNS as well as potential efficacy of pembrolizumab in reversing immune&#xD;
      exhaustion against latent HIV&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2018</start_date>
  <completion_date type="Actual">February 13, 2023</completion_date>
  <primary_completion_date type="Actual">February 13, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary goal of the study is to determine the safety of a single dose of pembrolizumab in HIV-positive patients.</measure>
    <time_frame>ongoing</time_frame>
    <description>The primary outcome will be the safety and tolerability of pembrolizumab, which will be measured by clinical exam, laboratory studies and adverse event tabulations using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HIV-specific antibody responses in the CSF and serum using LIPS assay.</measure>
    <time_frame>research blood draw at week 0, 3,6, 12, 18, 24 and 52</time_frame>
    <description>We will analyze antibodies to Tat. We will use the Berlin patient s antibody levels as a benchmark for the post-treatment of the study participants to compare the following proteins: gp41, gp120, matrix, p24, nucleocapsid, reverse transcription, integrase, protease, and tat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CSF cytokine profile post-study drug</measure>
    <time_frame>lumbar puncture at baseline and week 3</time_frame>
    <description>change between baseline and week 3</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pembrolizumab 200mg will be administered as a one-time intravenous infusion over 30 minutes during the treatment phase of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Participants will receive one dose of 2mg/kg of pembrolizumab IV at Week 0.</description>
    <arm_group_label>Pembrolizumab arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Diagnosis of HIV-1 infection, with positive HIV 1 antibody testing&#xD;
&#xD;
          -  HIV RNA less than or equal to 40 copies/mL in plasma in the last 12 or greater months&#xD;
&#xD;
          -  CD4 count above 350 cells/uL&#xD;
&#xD;
          -  Antiretroviral therapy for 12 months prior to trial&#xD;
&#xD;
          -  Fully vaccinated against SARS-CoV-2. Fully vaccinated is defined as:&#xD;
&#xD;
               -  Two weeks out from the second dose of a two-dose vaccine series (Moderna,&#xD;
                  Pfizer-BioNTech); or&#xD;
&#xD;
               -  Two weeks out from a single-dose vaccine (Johnson &amp; Johnson/Janssen)&#xD;
&#xD;
          -  Patient must be willing and able to comply with all the aspects of trial design and&#xD;
             follow-up.&#xD;
&#xD;
          -  Patients must be able to provide informed consent&#xD;
&#xD;
          -  Women of childbearing potential must agree to use contraception (defined as two forms&#xD;
             of effective birth control), from the time of enrollment until 4 months after the last&#xD;
             exposure to pembrolizumab&#xD;
&#xD;
          -  Participants who are physically able to father a child must agree to use 2 effective&#xD;
             methods of contraception (birth control) from the time you enroll in the study until 4&#xD;
             months after your last exposure to pembrolizumab&#xD;
&#xD;
               -  Effective methods of contraception for this study include:&#xD;
&#xD;
                    -  hormonal contraception (birth control pills, birth control patches, injected&#xD;
                       hormones, hormonal implants or vaginal ring),&#xD;
&#xD;
                    -  Intrauterine device,&#xD;
&#xD;
                    -  Barrier methods (condom or diaphragm) combined with spermicide, and&#xD;
&#xD;
                    -  Surgical sterilization (hysterectomy, tubal ligation, or vasectomy).&#xD;
&#xD;
                    -  If you have had a hysterectomy, tubal ligation, or vasectomy (or have a&#xD;
                       partner with a hysterectomy, tubal ligation or vasectomy), you do not have&#xD;
                       to use 2 methods of birth control.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Clinically significant medical disorders that might expose the patient to undue risk&#xD;
             of harm confound study outcomes or prevent the patient from completing the study as&#xD;
             identified on screening studies and by patient history. Examples of such conditions&#xD;
             include known cardiac disease such as congestive heart failure, chronic obstructive&#xD;
             pulmonary disease, uncontrolled hypertension, kidney disease, liver disease, endocrine&#xD;
             disease, pulmonary disease, heart disease, progressive CNS disease such as Parkinson s&#xD;
             disease, dementia, prior tuberculosis infection or ongoing CNS opportunistic&#xD;
             infection.&#xD;
&#xD;
          -  Patient has received immunomodulatory/immunosuppressive therapy (including IV steroids&#xD;
             but excluding local injections) in the preceding 6 months.&#xD;
&#xD;
          -  Patient with known autoimmunity that would include but is not limited to disorders&#xD;
             such as hypo/hyperthyroidism, myasthenia gravis, diabetes mellitus type 1, hemolytic&#xD;
             anemia, and immune mediated hepatitis (but excluding patients with hypothyroidism&#xD;
             already on thyroid replacement therapy).&#xD;
&#xD;
          -  Prior history of cancer (excluding non-invasive squamous and basal cell carcinoma)&#xD;
&#xD;
          -  Any opportunistic infection in the prior 2 years (excluding thrush) including latent&#xD;
             TB (or a positive TB Quantiferon Gold test)&#xD;
&#xD;
          -  Patient has received other investigational drugs within 3 months before enrollment&#xD;
&#xD;
          -  Positive serological or PCR evidence of active or prior infection with HTLV-1/II,&#xD;
             Hepatitis B or C. Patients with hepatitis B core (+), surface antibody (+), surface&#xD;
             antigen ( ) and hepatitis B DNA (-) eligible to participate in the study (provided&#xD;
             they are on tenofovir, lamivudine or TAF). Participants with prior hepatitis C who are&#xD;
             hepatitis C antibody (+) but hepatitis C RNA (-) with normal liver enzymes and no&#xD;
             evidence of cirrhosis on clinical liver ultrasound are eligible to participate in the&#xD;
             study.&#xD;
&#xD;
          -  Metal in the body which would make having an MRI scan unsafe, such as pacemakers,&#xD;
             stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves,&#xD;
             cochlear implants or shrapnel fragments, or history of welding or metal worker&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Inability to lie comfortably on the back for up to two hours.&#xD;
&#xD;
          -  Abnormal anti-thyroid panel (anti-TPO and anti-TG) test at screening visit.&#xD;
&#xD;
          -  Abnormal screening/baseline blood tests exceeding any of the limits defined below or&#xD;
             as deemed exclusionary by the investigators on review:&#xD;
&#xD;
               -  AST and ALT values &gt;1.1 times ULN&#xD;
&#xD;
               -  Fasting triglyceride &gt; 300 mg/dL&#xD;
&#xD;
               -  Total bilirubin &gt;1.1 times ULN (unless participant is taking atazanavir or has&#xD;
                  Gilbert syndrome)&#xD;
&#xD;
               -  Creatinine Clearance or eGFR &lt;60 ml/minute (adjusted for race)&#xD;
&#xD;
               -  Hemoglobin &lt; 10 g/dL&#xD;
&#xD;
               -  Absolute neutrophil count &lt; 1000/microliter&#xD;
&#xD;
               -  Platelet count &lt;130,000/mm(3) (if platelet clumping is present on hematology&#xD;
                  slide review, platelet count &lt;100,000/mm3 is considered exclusionary to study)&#xD;
&#xD;
               -  Hemoglobin A1c greater than or equal to 6%&#xD;
&#xD;
               -  Thyroid-stimulating hormone (TSH) and adrenocorticotropic hormone (ACTH) within&#xD;
                  normal limits. If TSH is not within normal limits then the participant may be&#xD;
                  eligible if thyroxine (T4) is within normal limits. Participants are not excluded&#xD;
                  if they are on a stable dose of replacement thyroid medication; dose may be&#xD;
                  adjusted as needed.&#xD;
&#xD;
          -  An employee or staff of the NIH&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren B Reoma, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Neurological Disorders and Stroke (NINDS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-N-0145.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>February 13, 2023</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Brain</keyword>
  <keyword>Immunotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication, or at the time of publication</ipd_time_frame>
    <ipd_access_criteria>At request, through existing NIH technology transfer policy methods</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03239899
org study id: 170145
secondary id: 17-N-0145
nct id: NCT03239899
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Background:

      HIV affects millions of people. The disease may "hide" in the brain, even in people with
      well-controlled HIV without cancer. Then it may "wake up" and continue. The drug
      pembrolizumab uses the body s immune system to fight cells like cancer cells. It is approved
      to treat some cancers but not HIV. Researchers want to see if it is safe for HIV-positive
      people without cancer. This study is not for HIV treatment; only one dose of the drug will be
      used.

      Objective:

      To learn if the drug pembrolizumab, used to treat certain cancers, is safe for HIV-positive
      people.

      Eligibility:

      Adults ages 18 and older with HIV who are in another NIH protocol

      Design:

      Participants will be screened with:

        -  Medical history

        -  Physical and neurological exams

        -  Blood tests

        -  Lumbar puncture. The lower back will be numbed. A needle will remove fluid from between
           back bones.

        -  FDG-PET/CT. A radioactive sugar will be injected in a thin plastic tube (catheter)
           inserted in an arm vein. Participants will rest for an hour, urinate, then lie in the
           scanner. A mask will hold the head still.

        -  Leukapheresis. An optional procedure at baseline. White blood cells are removed from you
           using a serum cell separator machine

      Women who can become pregnant cannot take pembrolizumab. Men who take it must use 2 kinds of
      contraception.

      Participants will have up to 7 more visits, which repeat some screening tests.

      At 1 visit, participants will get one dose of pembrolizumab by catheter for 30 minutes. They
      will get allergy and pain medicines.

      At 2 visits, participants will have a brain MRI. They will get a contrast agent by catheter.
      They will lie in a metal cylinder that takes pictures for 1-2 hours. They will get earplugs
      for loud sounds.
Objective

      In this Phase I, proof-of-concept study, we aim to determine the safety and tolerability of
      pembrolizumab, an FDA-approved monoclonal antibody against programmed cell death protein
      (PD)-1, in viremically suppressed human immunodeficiency virus-1 (HIV) positive patients. We
      are examining the correlation of immune activation and suppression markers in viremically
      suppressed HIV positive patients with the effects of pembrolizumab on immune restoration
      function (e.g. CD4 count, HIV viral load) and immune activation (e.g. HIV-specific T-cell
      responses).

      Study Population

      HIV is estimated to infect 37.6 million people globally, with 690,000 deaths and 1.5 million
      new infections occurring yearly. There is no cure. Opportunistic infections and neoplasms
      contribute to a large portion of mortality and morbidity within the HIV-positive population.
      Even in well- controlled, viremically suppressed patients, neurologic complications including
      HIV-associated neurocognitive disorder, continue to contribute to disease morbidity and
      mortality.

      There is evidence that HIV reservoirs contribute to the inability to cure HIV infection. In
      the brain, macrophages and astrocytes harbor HIV. It is theorized that the brain is a
      potential reservoir for replication competent HIV. PD-1 expression is elevated in patients
      with HIV compared to uninfected controls. Upregulated PD-1 expression is associated with
      higher viral load and increased mortality in infections.1 PD-1 co-expression on regulatory
      T-cells has been shown to correlate with disease progression in perinatally-infected
      HIV-positive children. Drugs targeting the PD-1 pathway in HIV infection have shown
      upregulation of T-cell responses that are potentially critical to eradication of infection.
      Pembrolizumab is an attractive option due to its mechanism of action, although it has been
      rarely used in the HIV population.

      Design

      In this single-center, single-arm, open label, baseline-versus-treatment phase I clinical
      trial, twelve patients with HIV-1 infection receive a one-time dose of 200mg pembrolizumab
      with a baseline study period of 3 weeks, a one-day treatment phase, and a 6-month post
      treatment phase. Outcome measures are collected every 3 to 6 weeks for the duration of the
      study.

      Outcome Measures

      The primary outcome is the safety and tolerability of pembrolizumab, which is measured by
      clinical exam, laboratory studies and adverse event tabulations using the Common Terminology
      Criteria for Adverse Events (CTCAE) v5.0.

      In addition, viral and immunologic outcome measures investigating the impact of pembrolizumab
      on HIV-1 biology and its effects on immune function is measured in the CSF and periphery,
      including single copy HIV analysis, CD4+ T-cell count, PD-1 lymphocyte expression and T-cell
      phenotype analysis, T-cell proliferation against HIV-proteins, CSF cytokine analysis and/or
      CSF antibody profiling (LIPS). These additional studies offer indirect proof of a HIV viral
      reservoir in the CNS as well as potential efficacy of pembrolizumab in reversing immune
      exhaustion against latent HIV
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary goal of the study is to determine the safety of a single dose of pembrolizumab in HIV-positive patients.
time frame: ongoing
description: The primary outcome will be the safety and tolerability of pembrolizumab, which will be measured by clinical exam, laboratory studies and adverse event tabulations using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
measure: Change in HIV-specific antibody responses in the CSF and serum using LIPS assay.
time frame: research blood draw at week 0, 3,6, 12, 18, 24 and 52
description: We will analyze antibodies to Tat. We will use the Berlin patient s antibody levels as a benchmark for the post-treatment of the study participants to compare the following proteins: gp41, gp120, matrix, p24, nucleocapsid, reverse transcription, integrase, protease, and tat.
measure: Change in CSF cytokine profile post-study drug
time frame: lumbar puncture at baseline and week 3
description: change between baseline and week 3
arm group label: Pembrolizumab arm
arm group type: Experimental
description: Pembrolizumab 200mg will be administered as a one-time intravenous infusion over 30 minutes during the treatment phase of the study.
intervention type: Drug
intervention name: Pembrolizumab
description: Participants will receive one dose of 2mg/kg of pembrolizumab IV at Week 0.
arm group label: Pembrolizumab arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Lauren B Reoma, M.D.
role: Principal Investigator
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-N-0145.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Pembrolizumab
sharing ipd: Yes
ipd description: .all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Starting 6 months after publication, or at the time of publication
ipd access criteria: At request, through existing NIH technology transfer policy methods