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

Sponsor

VaxGen (Industry)

Overall Status

Completed

CT.gov ID

NCT00006327

Collaborator

(none)

2,500

Enrollment

Location

17.1

Duration (Months)

146.6

Patients Per Site Per Month

Study Details

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

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 :

Mar 1, 1999

Study Completion Date :

Aug 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.