Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
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ClinicalTrials.gov Identifier: NCT00337181
Recruitment Status :
Active, not recruiting
First Posted : June 15, 2006
Last Update Posted : May 5, 2017
U.S. Army Medical Research and Materiel Command
Walter Reed Army Institute of Research (WRAIR)
Royal Thai Ministry of Public Health
Armed Forces Research Institute of Medical Sciences, Thailand
This protocol will study the clinical course of HIV-infection among volunteers who have received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and AIDSVAX B/E prior to HIV-1 infection. The study will assess whether those who received the experimental vaccine combination have a slower progression of HIV disease compared to those who received the placebo injection.
Condition or disease
Prospective cohort study of the clinical course of HIV-1 infection occurring after candidate HIV-1 vaccination (breakthrough infection) with ALVAC-HIV (vcP1521) and AIDSVAX B/E. This study will enroll volunteers who become HIV-infected during the course of follow up in a phase III preventive HIV vaccine trial conducted in Rayong and Chon Buri, Thailand. Volunteers will be enrolled in this protocol to provide additional long-term follow up to establish whether differences in viral load after infection (comparing vaccine to placebo) are associated with altered disease outcomes, as well as provide more detailed immunologic and virologic assessment of these volunteers.
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Ages Eligible for Study:
18 Years to 31 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All individuals who become HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical tria if they received at least injection.
The volunteer must give written, informed consent.
Persons who have a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
Persons who become HIV-infected after the completion of the RV144 protocol.