Clinical Trials

MainTitle

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

This study has been completed
Sponsor
VaxGen


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00006327

First received: October 2, 2000
Last updated: June 23, 2005
Last Verified: June 2003
History of Changes
Purpose

Purpose

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: 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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Enrollment: 2500
Study Start Date: March 1999
Study Completion Date: August 2000

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.

Eligibility

Eligibility

Ages Eligible for Study: 20 Years to 60 Years  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006327

Locations

Thailand
Kachit Choopanya
Klongsan / Bangkok, Thailand

Sponsors and Collaborators

VaxGen

Investigators

Principal Investigator: Kachit Choopanya
More Information

More Information


Responsible Party: VaxGen  
ClinicalTrials.gov Identifier: NCT00006327   History of Changes  
Other Study ID Numbers: VAX 003  
Study First Received: October 2, 2000  
Last Updated: June 23, 2005  

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

ClinicalTrials.gov processed this data on July 08, 2020
This information is provided by ClinicalTrials.gov.