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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00006327
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infections HIV Seronegativity Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Masking: Double
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
Study Start Date : March 1999
Estimated Study Completion Date : August 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006327


Locations
Thailand
Kachit Choopanya
Klongsan / Bangkok, Thailand
Sponsors and Collaborators
VaxGen
Investigators
Principal Investigator: Kachit Choopanya
More Information

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
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2003

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases