Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
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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 |
| Estimated Enrollment: | 5000 |
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 |
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
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| 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 May 16, 2013