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

This study has been completed.
Sponsor:
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

October 2, 2000
June 23, 2005
March 1999
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Complete list of historical versions of study NCT00006327 on ClinicalTrials.gov Archive Site
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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

The 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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Prevention
  • HIV Infections
  • HIV Seronegativity
Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2500
August 2000
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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.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00006327
VAX 003
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VaxGen
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Principal Investigator: Kachit Choopanya
NIH AIDS Clinical Trials Information Service
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP