Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	VaxGen
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002441

Purpose

The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who are at risk from becoming infected with HIV. Patients who become infected despite immunization will be studied to see if receiving the vaccine before becoming infected will help keep HIV levels (viral load) low.

Condition	Intervention	Phase
HIV Infections HIV Seronegativity	Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1	Phase III

Study Type:	Interventional
Study Design:	Prevention, Double-Blind, Safety Study
Official Title:	A Phase III Trial to Determine the Efficacy of Bivalent AIDSVAX B/B Vaccine in Adults at Risk of Sexually Transmitted HIV-1 Infection in North America

Resource links provided by NLM:

MedlinePlus related topics: AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

5000

Detailed Description:

Volunteers receive 7 blinded, intramuscular vaccinations (at Months 0, 1, 6, 12, 18, 24, 30) containing either the AIDSVAX B/B vaccine or a placebo (aluminum adjuvant only). Volunteers are randomized in a 2 to 1 vaccine-to-placebo ratio. HIV-uninfected persons are followed for a total of 16 visits beginning at screening and continuing until Month 36. Patients who become HIV infected during study are followed every 4 months for at least 24 months.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Exclusion Criteria

You will not be eligible for this study if you:

Use injection drugs.
Have a history of any serious diseases or conditions, including lymphoma.
Have ever received an HIV vaccine.
Have taken post-exposure treatment to prevent HIV infection within 4 weeks prior to study entry.
Are planning to take other HIV vaccines during this study.
Are pregnant.
Have taken certain medications or received certain therapies, including chemotherapy and radiation.
Have received certain vaccines within 2-4 weeks prior to study entry.

You may be eligible for this study if you:

Are HIV-negative.
Are between 18 and 60 years old.
Are available for 3 years of follow-up.
Agree to use effective methods of birth control during the study and for 90 days after.
Are one of the following:
A woman who is currently in a sexual relationship with an HIV-positive man.
A woman who has had more than one male partner and at least one sexually transmitted disease (STD) within the past 12 months.
A man who has sex with men and has had anal intercourse within the past 12 months. (You will not be eligible if you have been in the same relationship with only one HIV-negative man for at least 12 months.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002441

Show 67 Study Locations

Sponsors and Collaborators

VaxGen

More Information

No publications provided

Study ID Numbers:	VAX 004
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002441 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
AIDS Vaccines
Sexually Transmitted Diseases

Risk Factors
HIV Seronegativity
Antigens, Viral
Alum Compounds

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Aluminum sulfate
HIV Infections

Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 01, 2009