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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002441
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 2000
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 67 Study Locations
Sponsors and Collaborators
VaxGen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002441     History of Changes
Other Study ID Numbers: VAX 004
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 19, 2014