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

NCT03337906 | Completed

• 1 other identifier: HVTN 802
• Study Type: observational
• Target: 209
• Locations: 6 countries
• Sites: 21

Brief Summary

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

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons

  8 years

• Occurrence of HIV/AIDS associated events, including death

  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

  24, 48, 96, and 144 weeks

• Adherence information collected at 24, 48, 96, and 144 weeks following initiation of ART

  24, 48, 96, and 144 weeks

• Side effects collected at 24, 48, 96, and 144 weeks following initiation of ART

  24, 48, 96, and 144 weeks

Study Arms (1)

Participants infected with HIV-1

Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials

Other: Observation

Interventions

Observation OTHER

Participants infected with HIV-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Ability and willingness to provide written informed consent to participate in the study.
• Ability and willingness to adhere to the on-study follow-up schedule.
• Ability and willingness to provide adequate information for locator purposes.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• HIV Vaccine Trials Network: lead

Study Sites (21)

Alabama Vaccine CRS

Birmingham, Alabama, 35294, United States

Location

Bridge HIV CRS

San Francisco, California, 94143, United States

Location

The Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia, 30030, United States

Location

UIC Project WISH CRS

Chicago, Illinois, 60612, United States

Location

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, 02115-6110, United States

Location

Fenway Health Clinical Research Site CRS

Boston, Massachusetts, 02215-4302, United States

Location

NY Blood Ctr./Union Square CRS

New York, New York, 10003, United States

Location

Columbia P&S CRS

New York, New York, 10032-3732, United States

Location

NY Blood Ctr./Bronx CRS

New York, New York, 10455, United States

Location

University of Rochester Vaccines to Prevent HIV Infection CRS

New York, New York, 14642, United States

Location

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt Vaccine (VV) CRS

Nashville, Tennessee, 37232-2582, United States

Location

Seattle Vaccine and Prevention CRS

Seattle, Washington, 98109-1024, United States

Location

Unidad de Vacunas IDCP-COIN-DIGECITSS CRS

Santo Domingo, Dominican Republic

Location

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS

Port-au-Prince, HT-6110, Haiti

Location

ACSA CRS

Iquitos, Maynas, 1, Peru

Location

Maternal-Infant Studies Center (CEMI) CRS

San Juan, 00935, Puerto Rico

Location

Soweto HVTN CRS

Johannesburg, Gauteng, 1862, South Africa

Location

eThekwini CRS

Durban, KwaZulu-Natal, 4013, South Africa

Location

Aurum Institute Klerksdorp CRS

Klerksdorp, North West, 2571, South Africa

Location

Emavundleni CRS

Cape Town, Western Cape, 7750, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Observation

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Magdalena Sobieszcyk

  Columbia University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 9, 2017
• Study Start: July 11, 2008
• Primary Completion: July 11, 2015
• Study Completion: July 1, 2016
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

DO (1); PE (1); ZA (4); PR (1); US (13); HA (1)