<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/NCT03307915</url>
  </required_header>
  <id_info>
    <org_study_id>CR108372</org_study_id>
    <secondary_id>VAC89220HTX1002</secondary_id>
    <secondary_id>IPCAVD-013</secondary_id>
    <nct_id>NCT03307915</nct_id>
  </id_info>
  <brief_title>A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment</brief_title>
  <official_title>A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With MVA-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in HIV-1 Infected Adults on Suppressive ART</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Vaccines &amp; Prevention B.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ragon Institute of MGH, MIT and Harvard</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Military HIV Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Janssen Vaccines &amp; Prevention B.V.</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost&#xD;
      regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA)&#xD;
      -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1&#xD;
      (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2018</start_date>
  <completion_date type="Actual">November 5, 2021</completion_date>
  <primary_completion_date type="Actual">November 5, 2021</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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability</measure>
    <time_frame>7 days post-vaccination (approximately up to 37 weeks)</time_frame>
    <description>Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability</measure>
    <time_frame>7 days post-vaccination (approximately up to 37 weeks)</time_frame>
    <description>Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With AEs as a Measure of Safety and Tolerability</measure>
    <time_frame>Approximately up to 96 weeks</time_frame>
    <description>An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total IgG and Subclass Specific Antibody Titer</measure>
    <time_frame>Up to post-vaccination follow-up period until Week 96</time_frame>
    <description>Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP)</measure>
    <time_frame>Up to post-vaccination follow-up period until Week 96</time_frame>
    <description>Antibody functionality assessment will be assessed by antibody-dependent cell-mediated phagocytosis (ADCP) assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay</measure>
    <time_frame>Up to post-vaccination follow-up period until Week 96</time_frame>
    <description>Intracellular cytokine staining (ICS) assays with Env, group-specific antigen (Gag), and/or polymerase (Pol)-peptide pools will be used to determine the magnitude of T-cell responses elicited.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality of T-cell Responses as Measured by ICS Assay</measure>
    <time_frame>Up to post-vaccination follow-up period until Week 96</time_frame>
    <description>ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the functionality of T-cell responses elicited.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phenotype of T-cell Responses as Measured by ICS Assay</measure>
    <time_frame>Up to post-vaccination follow-up period until Week 96</time_frame>
    <description>ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the phenotype of T-cell responses elicited.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)</measure>
    <time_frame>Up to post-vaccination follow-up period until Week 96</time_frame>
    <description>Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive adenovirus serotype 26-Mosaic 4 -Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) as intramuscular (IM) injection at Weeks 0 and 12 (1 injection) followed by modified Vaccinia Ankara-Mosaic (MVA-Mosaic) 10^8 Plaque-forming unit (pfu) and placebo as IM injection at Weeks 24 and 36 (2 injections).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Ad26.Mos4.HIV, 5*10^10 vp as IM injection at Weeks 0 and 12 (1 injection) followed by both Ad26.Mos4.HIV 5*10^10 vp plus Clade C gp140 (125 microgram [mcg]) plus Mosaic gp140 (125 mcg) with aluminum phosphate adjuvant or an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36 (2 injections).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive 0.9 percent (%) saline as IM injection at Weeks 0, 12 (one injection) and at Week 24, 36 (two injections).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ad26.Mos4.HIV</intervention_name>
    <description>Participants will receive Ad26.Mos4.HIV 5*10^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.</description>
    <arm_group_label>Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo</arm_group_label>
    <arm_group_label>Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MVA-Mosaic</intervention_name>
    <description>Participants will receive MVA-Mosaic 10^8 pfu as IM injection at Weeks 24 and 36.</description>
    <arm_group_label>Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Clade C gp140 + Mosaic gp140</intervention_name>
    <description>Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.</description>
    <arm_group_label>Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.</description>
    <arm_group_label>Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo</arm_group_label>
    <arm_group_label>Group 3: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each participant must have documented Human immunodeficiency virus type1 (HIV-1)&#xD;
             infection&#xD;
&#xD;
          -  Each participant must be on suppressive antiretroviral treatment (ART) for at least 48&#xD;
             weeks prior to randomization and on stable suppressive ART for at least 4 weeks prior&#xD;
             to screening. Changes in antiretrovirals (ARVs) can be made for safety/tolerability&#xD;
             reasons only until 4 weeks prior to screening&#xD;
&#xD;
          -  Each participant must have started ART outside of the acute or early phase of&#xD;
             infection&#xD;
&#xD;
          -  Each participant must have a plasma HIV ribonucleic acid (RNA) less than (&lt;) 50&#xD;
             copies/ milliliter (mL) at screening and at least one documented evidence of plasma&#xD;
             HIV RNA &lt;50 copies/mL after the last ART change. In case of ART change within the 48&#xD;
             weeks prior randomization, at least one additional more recent documented plasma HIV&#xD;
             RNA &lt;50 copies/mL is required. One blip of HIV RNA greater than (&gt;)50 and &lt;200&#xD;
             copies/mL within 24 weeks prior to screening is acceptable, provided that the 2 most&#xD;
             recent (after last ART change, tested before and/or during screening) HIV RNA results&#xD;
             are &lt;50 copies/mL&#xD;
&#xD;
          -  Each participant must be medically stable as confirmed by medical history, physical&#xD;
             examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory&#xD;
             tests performed at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled&#xD;
             in this study, or within 3 months after the last vaccination&#xD;
&#xD;
          -  Anyone with contraindication to intramuscular injections and blood draws example,&#xD;
             bleeding disorders&#xD;
&#xD;
          -  Anyone with acute illness (this does not include minor illnesses such as diarrhea or&#xD;
             mild upper respiratory tract infection) or temperature greater than or equal to (&gt;=)&#xD;
             38.0ºC (degree centigrade) within 24 hours prior to the first dose of study vaccine;&#xD;
             enrollment at a later date is permitted&#xD;
&#xD;
          -  Anyone with a history of malignancy within 5 years before screening (exceptions are&#xD;
             squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or&#xD;
             malignancy, which is considered cured with minimal risk of recurrence)&#xD;
&#xD;
          -  Anyone with a history of an underlying clinically significant acute or uncontrolled&#xD;
             chronic medical condition or physical examination findings for which, in the opinion&#xD;
             of the investigator, participation would not be in the best interest of the&#xD;
             participant (example, compromise the well-being) or that could prevent, limit, or&#xD;
             confound the protocol-specified assessments&#xD;
&#xD;
          -  Anyone with a history of Acquired Immunodeficiency Syndrome (AIDS)-defining illness&#xD;
             according to Centers for Disease Control and prevention (CDC) criteria based on&#xD;
             available medical history and assessed by the investigator as clinically relevant. A&#xD;
             case summary for every participant with AIDS-defining illnesses assessed by the&#xD;
             investigator as clinically irrelevant must be provided to the sponsor and Protocol&#xD;
             Safety Review Team (PSRT), who will determine eligibility on a case-by-case basis&#xD;
             prior to randomization&#xD;
&#xD;
          -  Anyone with a history of CD4+ less than (&lt;) 200 cells per millimeter cube&#xD;
             (cells/mm^3), based on available medical history and assessed by the investigator as&#xD;
             clinically relevant. A case summary for every participant with history of CD4+ &lt;200&#xD;
             cells/mm^3 assessed by the investigator as clinically irrelevant must be provided to&#xD;
             the sponsor and PSRT, who will determine eligibility on a case-by-case basis prior to&#xD;
             randomization&#xD;
&#xD;
          -  Anyone with chronic active hepatitis B (measured by hepatitis B surface antigen test)&#xD;
             or active hepatitis C (measured by hepatitis C virus [HCV] antibody test; if positive,&#xD;
             HCV RNA polymerase chain reaction test will be used to confirm active versus past HCV&#xD;
             infection) or syphilis infection that has not been effectively treated. Positive&#xD;
             syphilis serology due to past effectively treated infection is not exclusionary&#xD;
&#xD;
          -  Anyone who received or plans to receive: a) licensed live attenuated vaccines within&#xD;
             28 days before or after planned administration of any of the study vaccinations; b)&#xD;
             other licensed (not live) vaccines - within 14 days before or after planned&#xD;
             administration of any of the study vaccinations&#xD;
&#xD;
          -  Anyone who received an investigational drug or used an invasive investigational&#xD;
             medical device within 30 days or received an investigational vaccine within 6 months&#xD;
             before the planned administration of the first dose of study vaccine. Receipt of&#xD;
             prophylactic or therapeutic HIV vaccine candidate at any time is always exclusionary.&#xD;
             Exceptions: Participants can be included where the vaccine received was subsequently&#xD;
             licensed. Participants with proof of having received only a placebo vaccine can also&#xD;
             be included&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Vaccines &amp; Prevention B.V. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Vaccines &amp; Prevention B.V.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <!-- 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/NCT03307915
org study id: CR108372
secondary id: VAC89220HTX1002
secondary id: IPCAVD-013
nct id: NCT03307915
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost
      regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA)
      -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1
      (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability
time frame: 7 days post-vaccination (approximately up to 37 weeks)
description: Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
measure: Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability
time frame: 7 days post-vaccination (approximately up to 37 weeks)
description: Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
measure: Percentage of Participants With AEs as a Measure of Safety and Tolerability
time frame: Approximately up to 96 weeks
description: An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
measure: Total IgG and Subclass Specific Antibody Titer
time frame: Up to post-vaccination follow-up period until Week 96
description: Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.
measure: Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP)
time frame: Up to post-vaccination follow-up period until Week 96
description: Antibody functionality assessment will be assessed by antibody-dependent cell-mediated phagocytosis (ADCP) assay.
measure: Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay
time frame: Up to post-vaccination follow-up period until Week 96
description: Intracellular cytokine staining (ICS) assays with Env, group-specific antigen (Gag), and/or polymerase (Pol)-peptide pools will be used to determine the magnitude of T-cell responses elicited.
measure: Functionality of T-cell Responses as Measured by ICS Assay
time frame: Up to post-vaccination follow-up period until Week 96
description: ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the functionality of T-cell responses elicited.
measure: Phenotype of T-cell Responses as Measured by ICS Assay
time frame: Up to post-vaccination follow-up period until Week 96
description: ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the phenotype of T-cell responses elicited.
measure: Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
time frame: Up to post-vaccination follow-up period until Week 96
description: Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).
arm group label: Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo
arm group type: Experimental
description: Participants will receive adenovirus serotype 26-Mosaic 4 -Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) as intramuscular (IM) injection at Weeks 0 and 12 (1 injection) followed by modified Vaccinia Ankara-Mosaic (MVA-Mosaic) 10^8 Plaque-forming unit (pfu) and placebo as IM injection at Weeks 24 and 36 (2 injections).
arm group label: Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140
arm group type: Experimental
description: Participants will receive Ad26.Mos4.HIV, 5*10^10 vp as IM injection at Weeks 0 and 12 (1 injection) followed by both Ad26.Mos4.HIV 5*10^10 vp plus Clade C gp140 (125 microgram [mcg]) plus Mosaic gp140 (125 mcg) with aluminum phosphate adjuvant or an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36 (2 injections).
arm group label: Group 3: Placebo
arm group type: Placebo Comparator
description: Participants will receive 0.9 percent (%) saline as IM injection at Weeks 0, 12 (one injection) and at Week 24, 36 (two injections).
intervention type: Biological
intervention name: Ad26.Mos4.HIV
description: Participants will receive Ad26.Mos4.HIV 5*10^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.
arm group label: Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo
arm group label: Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140
intervention type: Biological
intervention name: MVA-Mosaic
description: Participants will receive MVA-Mosaic 10^8 pfu as IM injection at Weeks 24 and 36.
arm group label: Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo
intervention type: Biological
intervention name: Clade C gp140 + Mosaic gp140
description: Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.
arm group label: Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140
intervention type: Drug
intervention name: Placebo
description: Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.
arm group label: Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo
arm group label: Group 3: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: Study Director
affiliation: Janssen Vaccines & Prevention B.V.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
mesh term: Immunologic Deficiency Syndromes