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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006327
Other study ID # VAX 003
Secondary ID
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
Est. primary completion date
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


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, 

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