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

Primary Purpose

HIV Infections, HIV Seronegativity

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
MN rgp120/HIV-1 and A244 rgp120/HIV-1
Sponsored by
VaxGen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Recombinant Proteins, HIV-1, AIDS Serodiagnosis, Substance Abuse, Intravenous, Enzyme-Linked Immunosorbent Assay, Blotting, Western, HIV Envelope Protein gp120, AIDSVAX

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kachit Choopanya

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 2, 2000
Last Updated
June 23, 2005
Sponsor
VaxGen
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1. Study Identification

Unique Protocol Identification Number
NCT00006327
Brief Title
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Official Title
A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Study Type
Interventional

2. Study Status

Record Verification Date
June 2003
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
VaxGen

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Seronegativity
Keywords
Recombinant Proteins, HIV-1, AIDS Serodiagnosis, Substance Abuse, Intravenous, Enzyme-Linked Immunosorbent Assay, Blotting, Western, HIV Envelope Protein gp120, AIDSVAX

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Enrollment
2500 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MN rgp120/HIV-1 and A244 rgp120/HIV-1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kachit Choopanya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kachit Choopanya
City
Klongsan / Bangkok
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
20079620
Citation
Martin M, Vanichseni S, Suntharasamai P, Mock PA, van Griensven F, Pitisuttithum P, Tappero JW, Chiamwongpaet S, Sangkum U, Kitayaporn D, Gurwith M, Choopanya K; Bangkok Vaccine Evaluation Group. Drug use and the risk of HIV infection amongst injection drug users participating in an HIV vaccine trial in Bangkok, 1999-2003. Int J Drug Policy. 2010 Jul;21(4):296-301. doi: 10.1016/j.drugpo.2009.12.002. Epub 2010 Jan 15.
Results Reference
derived
PubMed Identifier
19149819
Citation
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. doi: 10.1111/j.1360-0443.2008.02436.x.
Results Reference
derived

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

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