HIV Infections, HIV Seronegativity
Conditions
Keywords
Recombinant Proteins, HIV-1, AIDS Serodiagnosis, Substance Abuse, Intravenous, Enzyme-Linked Immunosorbent Assay, Blotting, Western, HIV Envelope Protein gp120, AIDSVAX
Brief summary
The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.
Detailed description
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.
Interventions
BIOLOGICALMN rgp120/HIV-1 and A244 rgp120/HIV-1
Sponsors
VaxGen
Study design
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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.
Countries
Thailand
Outcome results
None listed