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

HIV Infections Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002441
Study type Interventional
Source NIH AIDS Clinical Trials Information Service
Contact
Status Completed
Phase Phase 3
View Details
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