Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144
NCT01435135 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162
Last updated 2020-11-03
Summary
The purpose of this study is to assess safety and tolerability of late boost regimens of AIDSVAX B/E alone, ALVAC-HIV alone, or ALVAC-HIV/AIDSVAX B/E combination in HIV-uninfected participants from RV 144.
Conditions
- HIV Infections
Interventions
- BIOLOGICAL
-
ALVAC-HIV
1 mL per injection containing 10\^6 CCID50/dose administered
- BIOLOGICAL
-
AIDSVAX B/E
1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)
- BIOLOGICAL
-
ALVAC-HIV Placebo
1 ml per injection
- BIOLOGICAL
-
AIDSVAX B/E Placebo
1 ml per injection
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
U.S. Army Medical Research and Development Command
lead FED
Principal Investigators
-
Supachai Rerks-Ngarm, MD · Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2021-07-31
- Completion
- 2021-07-31
Countries
- Thailand
Study Locations
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