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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03337906
Other study ID # HVTN 802
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 11, 2008
Est. completion date July 1, 2016

Study information

Verified date April 2022
Source HIV Vaccine Trials Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date July 1, 2016
Est. primary completion date July 11, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Observation


Locations

Country Name City State
Dominican Republic Unidad de Vacunas IDCP-COIN-DIGECITSS CRS Santo Domingo
Haiti Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS Port-au-Prince
Peru ACSA CRS Iquitos Maynas
Puerto Rico Maternal-Infant Studies Center (CEMI) CRS San Juan
South Africa Emavundleni CRS Cape Town Western Cape
South Africa eThekwini CRS Durban Kwa Zulu Natal
South Africa Soweto HVTN CRS Johannesburg Gauteng
South Africa Aurum Institute Klerksdorp CRS Klerksdorp North West Province
United States Alabama Vaccine CRS Birmingham Alabama
United States Brigham and Women's Hospital Vaccine CRS (BWH VCRS) Boston Massachusetts
United States Fenway Health Clinical Research Site CRS Boston Massachusetts
United States UIC Project WISH CRS Chicago Illinois
United States The Hope Clinic of the Emory Vaccine Center CRS Decatur Georgia
United States Vanderbilt Vaccine (VV) CRS Nashville Tennessee
United States Columbia P&S CRS New York New York
United States NY Blood Ctr./Bronx CRS New York New York
United States NY Blood Ctr./Union Square CRS New York New York
United States University of Rochester Vaccines to Prevent HIV Infection CRS New York New York
United States Penn Prevention CRS Philadelphia Pennsylvania
United States Bridge HIV CRS San Francisco California
United States Seattle Vaccine and Prevention CRS Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
HIV Vaccine Trials Network

Countries where clinical trial is conducted

United States,  Dominican Republic,  Haiti,  Peru,  Puerto Rico,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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-? ELISpot and/or flow cytometry. 8 years
Primary 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-? ELISpot and/or flow cytometry. 8 years
Primary 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-? 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-? ELISpot and/or flow cytometry.
8 years
Primary 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-? 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-? ELISpot and/or flow cytometry.
8 years
Secondary 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-? ELISpot and/or flow cytometry. 8 years
Secondary 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-? ELISpot and/or flow cytometry. 8 years
Secondary 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-? ELISpot and/or flow cytometry. 24, 48, 96, and 144 weeks
Secondary 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-? ELISpot and/or flow cytometry. 24, 48, 96, and 144 weeks
Secondary 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-? ELISpot and/or flow cytometry. 24, 48, 96, and 144 weeks
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