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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006327
• Other study ID #: VAX 003
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2000
• Last updated: June 23, 2005
• Start date: March 1999
• Est. completion date: August 2000

Study information

• Verified date: June 2003
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: August 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Seronegativity

Intervention

Biological:
• MN rgp120/HIV-1 and A244 rgp120/HIV-1

Locations

Country	Name	City	State
Thailand	Kachit Choopanya	Klongsan / Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
VaxGen

Country where clinical trial is conducted

Thailand,