Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
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
1 other identifier
interventional
5,000
4 countries
67
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
January 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may not qualify if:
- 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:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VaxGenlead
Study Sites (67)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Phoenix Body Positive
Phoenix, Arizona, 85016, United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712, United States
Univ of California / UCI Med Ctr
Orange, California, 92868, United States
ViRx Inc
Palm Springs, California, 92262, United States
Univ of California - Davis Med Ctr / CARES
Sacramento, California, 95817, United States
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Santa Clara Public Health Dept
San Jose, California, 95128, United States
AIDS Research Alliance
West Hollywood, California, 90069, United States
Denver Hlth and Hosp Authority / Dept of Pub Hlth
Denver, Colorado, 80204, United States
Johns Hopkins Univ / Ctr for Immun Rsch
Washington D.C., District of Columbia, 20003, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Community AIDS Resource Inc
Coral Gables, Florida, 33146, United States
Community AIDS Resource Inc
Fort Lauderdale, Florida, 33308, United States
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209, United States
Community AIDS Resource Inc
Riviera Beach, Florida, 33404, United States
Infectious Disease Research Institute
Tampa, Florida, 33614, United States
Palm Beach Research Ctr
West Palm Beach, Florida, 33409, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610, United States
Univ of Illinois at Chicago / Dept of Medicine
Chicago, Illinois, 60612, United States
Howard Brown Health Ctr
Chicago, Illinois, 60613, United States
Community Hosp Indianapolis
Indianapolis, Indiana, 46219, United States
Louisiana State Univ Med Ctr / Infect Diseases
New Orleans, Louisiana, 70112, United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115, United States
Abbott Northwestern Hosp
Minneapolis, Minnesota, 55407, United States
Hennepin County Med Ctr
Minneapolis, Minnesota, 55415, United States
Park Nicollet Med Ctr / Hlth Education
Saint Louis Park, Minnesota, 55416, United States
St Paul Public Health
Saint Paul, Minnesota, 55101, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111, United States
Saint Louis Univ Hosp / Ctr for Vacc Dev
St Louis, Missouri, 63104, United States
Wellness Ctr / Las Vegas
Las Vegas, Nevada, 89102, United States
New Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131, United States
Albany Med College / Div of HIV Medicine
Albany, New York, 12208, United States
AIDS Services Erie County Med Ctr
Buffalo, New York, 14215, United States
St Luke Roosevelt Hosp
New York, New York, 10011, United States
New York Univ Med Ctr / Dept of Environmental Med
New York, New York, 10016, United States
Mount Sinai Med Ctr / Jack Martin Fund Clinic
New York, New York, 10029, United States
Dutchess County Dept of Health
Poughkeepsie, New York, 12601, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
New York Blood Ctr
The Bronx, New York, 10456, United States
Project Achieve - New York Blood Ctr - Women only
The Bronx, New York, 10456, United States
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207, United States
PW Clinical Research / LLC
Winston-Salem, North Carolina, 27103, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Ohio State Univ / ACTU-Univ Clinic
Columbus, Ohio, 43210, United States
Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
Tulsa, Oklahoma, 74104, United States
Research and Education Group
Portland, Oregon, 97210, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19017, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Miriam Hosp
Providence, Rhode Island, 02906, United States
Omega Med Research
Providence, Rhode Island, 02907, United States
Nelson Tebedo Health Resource Ctr
Dallas, Texas, 75219, United States
Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
Dallas, Texas, 75219, United States
Univ of Texas Med Branch Ctr for Clinical Studies
Galveston, Texas, 77555, United States
UTMB Ctr for Clinical Studies / St John Prof Bldg
Houston, Texas, 77058, United States
Univ of Washington
Seattle, Washington, 98104, United States
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, 53203, United States
St Pauls Hosp
Vancouver, British Columbia, Canada
Ctr Hosp de Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Municipal Health Service
Amsterdam, Netherlands
Clinical Research of Puerto Rico Inc
San Juan, 00909, Puerto Rico