An Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials

A Descriptive and Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials

An observational study of long-term outcomes of HIV-1 infection in persons who become infected after enrollment in HIV-1 vaccine trials

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: Observation

Detailed Description

A descriptive and observational study of long-term outcomes of HIV-1 infection in persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Unidad de Vacunas IDCP-COIN-DIGECITSS CRS
• Haiti
  • Port-au-Prince, Haiti, HT-6110
    • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
• Peru
  • Maynas
    • Iquitos, Maynas, Peru, 1
      • ACSA CRS
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • Maternal-Infant Studies Center (CEMI) CRS
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1862
      • Soweto HVTN CRS
  • Kwa Zulu Natal
    • Durban, Kwa Zulu Natal, South Africa, 4013
      • eThekwini CRS
  • North West Province
    • Klerksdorp, North West Province, South Africa, 2571
      • Aurum Institute Klerksdorp CRS
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7750
      • Emavundleni CRS
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Alabama Vaccine CRS
  • California
    • San Francisco, California, United States, 94143
      • Bridge HIV CRS
  • Georgia
    • Decatur, Georgia, United States, 30030
      • The Hope Clinic of the Emory Vaccine Center CRS
  • Illinois
    • Chicago, Illinois, United States, 60612
      • UIC Project WISH CRS
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-6110
      • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
    • Boston, Massachusetts, United States, 02215-4302
      • Fenway Health Clinical Research Site CRS
  • New York
    • New York, New York, United States, 10003
      • NY Blood Ctr./Union Square CRS
    • New York, New York, United States, 10032-3732
      • Columbia P&S CRS
    • New York, New York, United States, 10455
      • NY Blood Ctr./Bronx CRS
    • New York, New York, United States, 14642
      • University of Rochester Vaccines to Prevent HIV Infection CRS
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Prevention CRS
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2582
      • Vanderbilt Vaccine (VV) CRS
  • Washington
    • Seattle, Washington, United States, 98109-1024
      • Seattle Vaccine and Prevention CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Both vaccine and placebo recipients in HVTN trials in which HIV infection constitutes an endpoint (eg, test-of-concept, phase 2 and 3) who become HIV-1 infected after enrollment in the parent study and who meet the inclusion criteria may be offered enrollment in the study.

Description

Inclusion Criteria:

• Participants must meet the following criteria in order to be eligible for inclusion in the study:

  1. Confirmation of HIV-1 infection after enrollment in an HVTN vaccine trial in which HIV-1 infection constituted an endpoint, according to the diagnostic algorithm specified in the parent protocol.
  2. Ability and willingness to provide written informed consent to participate in the study.
  3. Ability and willingness to adhere to the on-study follow-up schedule.
  4. Ability and willingness to provide adequate information for locator purposes.
  5. Participants who are currently on ART or who previously received antiretrovirals as part of post-exposure prophylaxis, pre-exposure prophylaxis, or previous treatment regimen will be eligible for inclusion in this protocol. Their previous treatment history will be collected. If a participant has been on ART for more than 2 years, please consult with the protocol team leadership prior to enrollment.

  6. For participants initiating ART, agreement of participant and PHCP to initiate potent and durable ART regimens in accordance with local and international guidelines. Examples of potent and durable regimens are provided in Appendix H. Participants who initiate ART not consistent with regimens outlined in Appendix H may enroll with permission of the protocol chair or designee(s).

     Exclusion Criteria:

• Persons who meet the following criteria will be excluded from the study:

  1. Any medical, psychiatric, alcohol/drug dependency or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a participant's ability to give informed consent.
  2. Participants who meet these additional criteria will be excluded from the study:
• Participants undergoing acute therapy for serious medical illnesses (in the opinion of the site investigator) within 14 days prior to initiation of ART.
• Participants with chronic, acute, or recurrent infections that are serious (in the opinion of the site investigator).
• Participants who must continue with chronic (maintenance) therapy (e.g., tuberculosis [TB], pneumocystis pneumonia [PCP]), must have completed at least 14 days of therapy and be clinically stable prior to initiation of ART.
• Oral and vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses, as defined by the site investigator, present no restriction to eligibility.
• Participants undergoing radiation therapy, systemic chemotherapy, or receiving an immunomodulator within 45 days prior to initiation of ART. (A tapering course of corticosteroids as acute therapy for PCP or other conditions is an exception.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants infected with HIV-1; Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials	Other: Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure plasma HIV-1 RNA levels and CD4+ T cell counts longitudinally	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	8 years
Measure time to initiation of ART	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	8 years
Measure time to HIV-1 related clinical events	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry. Responses from ELISpot assays will be reported as the number of spot-forming cells Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	8 years
Proportion of individuals with plasma HIV-1 RNA level <50 copies/mL at 24 weeks after initiation of ART	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry. Responses from ELISpot assays will be reported as the number of spot-forming cells Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	8 years
Occurrence of HIV/AIDS associated events, including death	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	8 years
Proportion of subjects with HIV-1 RNA level <50 copies/mL post-initiation of ART; log change in plasma HIV-1 RNA levels and change in CD4+ T cell levels between baseline (at initiation of ART) and post-initiation of ART	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	24, 48, 96, and 144 weeks
Adherence information collected at 24, 48, 96, and 144 weeks following initiation of ART	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	24, 48, 96, and 144 weeks
Side effects collected at 24, 48, 96, and 144 weeks following initiation of ART	Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.	24, 48, 96, and 144 weeks

Collaborators and Investigators

• Sponsor: HIV Vaccine Trials Network
• Investigators: Study Chair: Magdalena Sobieszcyk, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2008
• Primary Completion (Actual): July 11, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: HVTN 802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No