Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
This study has been completed.
Sponsor:
VaxGen
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00006327
First received: October 2, 2000
Last updated: June 23, 2005
Last verified: June 2003
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections HIV Seronegativity |
Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1 |
Phase 3 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Prevention |
Official Title: | A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Estimated Enrollment: | 2500 |
Study Start Date: | March 1999 |
Estimated Study Completion Date: | August 2000 |
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.
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Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
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.
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No publications provided by NIH AIDS Clinical Trials Information Service
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00006327 History of Changes |
Other Study ID Numbers: | VAX 003 |
Study First Received: | October 2, 2000 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Recombinant Proteins HIV-1 AIDS Serodiagnosis Substance Abuse, Intravenous |
Enzyme-Linked Immunosorbent Assay Blotting, Western HIV Envelope Protein gp120 AIDSVAX |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013