Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand

Conditions
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HIV Infections, HIV Seronegativity

Intervention / Treatment
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* Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, AIDSVAX, Recombinant Proteins, AIDS Serodiagnosis, Substance Abuse, Intravenous, Enzyme-Linked Immunosorbent Assay, Blotting, Western, HIV Envelope Protein gp120