Title
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Phase
Phase 3Lead Sponsor
VaxGenStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HIV Infections HIV SeronegativityIntervention/Treatment
MN rgp120/HIV-1 and A244 rgp120/HIV-1 [mn rgp120/hiv-1 (94095), a244 rgp120/hiv-1 (103224)]Study Participants
2500The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.
Volunteers are immunized and followed for a minimum of 2 years. Any volunteer that becomes infected with HIV-1 is followed every 4 months post infection for up to 36 months. Behavior effects associated with study participation are assessed.
Inclusion Criteria Volunteers may be eligible for this study if they: Are 20 to 60 years old. Are HIV-negative. Have used intravenous drugs in the previous 12 months. Are available and commit to 3 years of follow-up. Have a Thai National ID or its equivalent such as government official ID or state enterprise ID. Are able to understand the study and pass a test showing they understand it, and give written informed consent. Exclusion Criteria Volunteers will not be eligible for this study if they: Have a serious disease or condition, or history of a serious disease or condition such as lymphoma, that would interfere with the study. Are HIV-positive. Have ever received an experimental HIV-1 vaccine. Have had or expect to have any treatments or medications that interfere with the immune system (e.g., long-term use of systemic steroids, chemotherapy, or radiation). Have received a vaccine or immunoglobulin within 2 weeks of receiving the first study injection, or other vaccines within 4 weeks of the first study injection. Have received immunoglobulins for a long time. Have received non-licensed, research agents within 4 weeks of the first study injection. Expect to miss study visits or plan to move within 36 months. Are pregnant or breast-feeding or plan to become pregnant during the 36-month study period. Are women who have sex with men and do not plan to use effective birth control.