Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug... | NCT00006327

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

NCT00006327

Sponsor

VaxGen

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

2,500

Phase

Phase 3

Conditions

HIV Infections
HIV Seronegativity

Interventions

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

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1999

Primary Completion Date

Not provided

Completion Date

Aug 2000

First Submitted Date

Oct 2, 2000

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500

Name	Type	Description	Arm Group Labels	Other Names
MN rgp120/HIV-1 and A244 rgp120/HIV-1	Biological

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kachit Choopanya		Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20079620	Derived	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.
19149819

ID	Term
D015658	HIV Infections
D015819	Substance Abuse, Intravenous

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral