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 Details — Status: Completed

Administrative data

• NCT number: NCT00002441
• Other study ID #: VAX 004
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.)

Study Design

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV Seronegativity
• Infection

Intervention

Biological:
• MN rgp120/HIV-1 and GNE8 rgp120/HIV-1

Locations

Country	Name	City	State
Canada	Ctr Hosp de Universite de Montreal (CHUM)	Montreal	Quebec
Canada	St Pauls Hosp	Vancouver	British Columbia
Netherlands	Municipal Health Service	Amsterdam
Puerto Rico	Clinical Research of Puerto Rico Inc	San Juan
United States	Albany Med College / Div of HIV Medicine	Albany	New York
United States	Univ of New Mexico Hlth Sciences Ctr / Dept of Med	Albuquerque	New Mexico
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Fenway Community Health Ctr	Boston	Massachusetts
United States	New York Blood Ctr	Bronx	New York
United States	Project Achieve - New York Blood Ctr - Women only	Bronx	New York
United States	AIDS Services Erie County Med Ctr	Buffalo	New York
United States	Nalle Clinic / Clinical Research Dept	Charlotte	North Carolina
United States	Chicago Ctr for Clinical Research	Chicago	Illinois
United States	Howard Brown Health Ctr	Chicago	Illinois
United States	Univ of Illinois at Chicago / Dept of Medicine	Chicago	Illinois
United States	Case Western Reserve Univ	Cleveland	Ohio
United States	Ohio State Univ / ACTU-Univ Clinic	Columbus	Ohio
United States	Community AIDS Resource Inc	Coral Gables	Florida
United States	Nelson Tebedo Health Resource Ctr	Dallas	Texas
United States	Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch	Dallas	Texas
United States	Denver Hlth and Hosp Authority / Dept of Pub Hlth	Denver	Colorado
United States	Community AIDS Resource Inc	Fort Lauderdale	Florida
United States	Univ of Texas Med Branch Ctr for Clinical Studies	Galveston	Texas
United States	Univ of Hawaii	Honolulu	Hawaii
United States	UTMB Ctr for Clinical Studies / St John Prof Bldg	Houston	Texas
United States	Community Hosp Indianapolis	Indianapolis	Indiana
United States	Boulevard Comprehensive Care Ctr	Jacksonville	Florida
United States	Kansas City AIDS Research Consortium	Kansas City	Missouri
United States	Wellness Ctr / Las Vegas	Las Vegas	Nevada
United States	Wisconsin AIDS Research Consortium	Milwaukee	Wisconsin
United States	Abbott Northwestern Hosp	Minneapolis	Minnesota
United States	Hennepin County Med Ctr	Minneapolis	Minnesota
United States	Louisiana State Univ Med Ctr / Infect Diseases	New Orleans	Louisiana
United States	Mount Sinai Med Ctr / Jack Martin Fund Clinic	New York	New York
United States	New York Univ Med Ctr / Dept of Environmental Med	New York	New York
United States	St Luke Roosevelt Hosp	New York	New York
United States	New Jersey Community Research Initiative	Newark	New Jersey
United States	Univ of California / UCI Med Ctr	Orange	California
United States	ViRx Inc	Palm Springs	California
United States	Mem Hosp of Rhode Island	Pawtucket	Rhode Island
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Phoenix Body Positive	Phoenix	Arizona
United States	Univ of Pittsburgh Med School	Pittsburgh	Pennsylvania
United States	Research and Education Group	Portland	Oregon
United States	Dutchess County Dept of Health	Poughkeepsie	New York
United States	Miriam Hosp	Providence	Rhode Island
United States	Omega Med Research	Providence	Rhode Island
United States	Community AIDS Resource Inc	Riviera Beach	Florida
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	Univ of California - Davis Med Ctr / CARES	Sacramento	California
United States	Saint Louis Univ Hosp / Ctr for Vacc Dev	Saint Louis	Missouri
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	Univ of Washington	Seattle	Washington
United States	Park Nicollet Med Ctr / Hlth Education	St. Louis Park	Minnesota
United States	St Paul Public Health	St. Paul	Minnesota
United States	Infectious Disease Research Institute	Tampa	Florida
United States	Arizona Clinical Research Ctr Inc	Tucson	Arizona
United States	Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg	Tulsa	Oklahoma
United States	Johns Hopkins Univ / Ctr for Immun Rsch	Washington	District of Columbia
United States	AIDS Research Alliance	West Hollywood	California
United States	Palm Beach Research Ctr	West Palm Beach	Florida
United States	PW Clinical Research / LLC	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VaxGen

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Puerto Rico,