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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337906
• Other study ID #: HVTN 802
• Status: Completed
• 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
• 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.)

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections

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