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

Completed

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT03337906

Run by

HIV Vaccine Trials Network

People needed

209

Starts

2008-07-11

Expected to finish

2016-07-01

Last updated by the study team

2022-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• Bridge HIV CRS — San Francisco, California, United States
• The Hope Clinic of the Emory Vaccine Center CRS — Decatur, Georgia, United States
• UIC Project WISH CRS — Chicago, Illinois, 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
• NY Blood Ctr./Union Square CRS — New York, New York, United States
• Columbia P&S CRS — New York, New York, United States
• NY Blood Ctr./Bronx 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
• Vanderbilt Vaccine (VV) CRS — Nashville, Tennessee, United States
• Seattle Vaccine and Prevention CRS — Seattle, Washington, United States
• Unidad de Vacunas IDCP-COIN-DIGECITSS CRS — Santo Domingo, Dominican Republic
• Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS — Port-au-Prince, Haiti
• ACSA CRS — Iquitos, Maynas, Peru
• Maternal-Infant Studies Center (CEMI) CRS — San Juan, Puerto Rico
• Soweto HVTN CRS — Johannesburg, Gauteng, South Africa
• eThekwini CRS — Durban, KwaZulu-Natal, South Africa
• Aurum Institute Klerksdorp CRS — Klerksdorp, North West, South Africa
• Emavundleni CRS — Cape Town, Western Cape, South Africa

Full record on ClinicalTrials.gov

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