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

Phase 3

Completed

• Conditions: HIV Infections; HIV Seronegativity

• Registration Number: NCT00002441
• Lead Sponsor: VaxGen

Brief 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.

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.

Study Timeline

• Study First Submitted: 1999-11-02
• Status Verified: 2000-01
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (65)

Univ of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Phoenix Body Positive; 🇺🇸 Phoenix, Arizona, United States

Arizona Clinical Research Ctr Inc; 🇺🇸 Tucson, Arizona, United States

Univ of California / UCI Med Ctr; 🇺🇸 Orange, California, United States

ViRx Inc; 🇺🇸 Palm Springs, California, United States

Univ of California - Davis Med Ctr / CARES; 🇺🇸 Sacramento, California, United States

San Francisco Dept of Hlth / AIDS Office; 🇺🇸 San Francisco, California, United States

San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

UCSF - San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Santa Clara Public Health Dept; 🇺🇸 San Jose, California, United States

Scroll for more (55 remaining)