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
NCT ID: NCT03337906
Last Updated: 2022-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
209 participants
OBSERVATIONAL
2008-07-11
2016-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants infected with HIV-1
Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials
Observation
Interventions
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Observation
Eligibility Criteria
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Inclusion Criteria
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
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.)
18 Years
ALL
Yes
Sponsors
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HIV Vaccine Trials Network
NETWORK
Responsible Party
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Principal Investigators
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Magdalena Sobieszcyk
Role: STUDY_CHAIR
Columbia University
Locations
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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
Countries
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Other Identifiers
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HVTN 802
Identifier Type: -
Identifier Source: org_study_id
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