NCT00006327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Mar 1999

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2000

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2003

First QC Date

October 2, 2000

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsHIV Seronegativity

Keywords

Recombinant ProteinsHIV-1AIDS SerodiagnosisSubstance Abuse, IntravenousEnzyme-Linked Immunosorbent AssayBlotting, WesternHIV Envelope Protein gp120AIDSVAX

Interventions

MN rgp120/HIV-1 and A244 rgp120/HIV-1BIOLOGICAL

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kachit Choopanya

Klongsan / Bangkok, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 20079620DERIVED

  • 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.

    PMID: 19149819DERIVED

MeSH Terms

Conditions

HIV InfectionsSubstance Abuse, Intravenous

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kachit Choopanya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2000

First Posted

August 31, 2001

Study Start

March 1, 1999

Study Completion

August 1, 2000

Last Updated

June 24, 2005

Record last verified: 2003-06

Locations

TH(1)