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

Tracking Information

First Received Date ^ICMJE

October 2, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

March 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006327 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Double-Blind, Efficacy Study

Condition ^ICMJE

HIV Infections
HIV Seronegativity

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

Suntharasamai P, Martin M, Vanichseni S, van Griensven F, Mock PA, Pitisuttithum P, Tappero JW, Sangkum U, Kitayaporn D, Gurwith M, Choopanya K; Bangkok Vaccine Evaluation Group. Factors associated with incarceration and incident human immunodeficiency virus (HIV) infection among injection drug users participating in an HIV vaccine trial in Bangkok, Thailand, 1999-2003. Addiction. 2009 Feb;104(2):235-42.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2500

Completion Date

August 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT ID ^ICMJE

NCT00006327

Responsible Party

Study ID Numbers ^ICMJE

VAX 003

Study Sponsor ^ICMJE

VaxGen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kachit Choopanya

Information Provided By

NIH AIDS Clinical Trials Information Service

Verification Date

June 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP