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Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: VaxGen
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002441
  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 III

Study Type: Interventional
Study Design: Prevention, Double-Blind, Safety Study
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 5000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002441

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85016
Arizona Clinical Research Ctr Inc
Tucson, Arizona, United States, 85712
United States, California
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
AIDS Research Alliance
West Hollywood, California, United States, 90069
Univ of California / UCI Med Ctr
Orange, California, United States, 92868
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, United States, 94102
Univ of California - Davis Med Ctr / CARES
Sacramento, California, United States, 95817
ViRx Inc
Palm Springs, California, United States, 92262
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Santa Clara Public Health Dept
San Jose, California, United States, 95128
United States, Colorado
Denver Hlth and Hosp Authority / Dept of Pub Hlth
Denver, Colorado, United States, 80204
United States, District of Columbia
Johns Hopkins Univ / Ctr for Immun Rsch
Washington, District of Columbia, United States, 20003
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Palm Beach Research Ctr
West Palm Beach, Florida, United States, 33409
Infectious Disease Research Institute
Tampa, Florida, United States, 33614
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, United States, 32209
Community AIDS Resource Inc
Fort Lauderdale, Florida, United States, 33308
Community AIDS Resource Inc
Coral Gables, Florida, United States, 33146
Community AIDS Resource Inc
Riviera Beach, Florida, United States, 33404
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Hawaii
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Illinois
Chicago Ctr for Clinical Research
Chicago, Illinois, United States, 60610
Univ of Illinois at Chicago / Dept of Medicine
Chicago, Illinois, United States, 60612
Howard Brown Health Ctr
Chicago, Illinois, United States, 60613
United States, Indiana
Community Hosp Indianapolis
Indianapolis, Indiana, United States, 46219
United States, Louisiana
Louisiana State Univ Med Ctr / Infect Diseases
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Fenway Community Health Ctr
Boston, Massachusetts, United States, 02115
United States, Minnesota
Abbott Northwestern Hosp
Minneapolis, Minnesota, United States, 55407
Hennepin County Med Ctr
Minneapolis, Minnesota, United States, 55415
St Paul Public Health
St. Paul, Minnesota, United States, 55101
Park Nicollet Med Ctr / Hlth Education
St. Louis Park, Minnesota, United States, 55416
United States, Missouri
Saint Louis Univ Hosp / Ctr for Vacc Dev
Saint Louis, Missouri, United States, 63104
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States, 64111
United States, Nevada
Wellness Ctr / Las Vegas
Las Vegas, Nevada, United States, 89102
United States, New Jersey
New Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
United States, New Mexico
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, United States, 87131
United States, New York
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
Albany Med College / Div of HIV Medicine
Albany, New York, United States, 12208
New York Univ Med Ctr / Dept of Environmental Med
New York, New York, United States, 10016
AIDS Services Erie County Med Ctr
Buffalo, New York, United States, 14215
Mount Sinai Med Ctr / Jack Martin Fund Clinic
New York, New York, United States, 10029
St Luke Roosevelt Hosp
New York, New York, United States, 10011
New York Blood Ctr
Bronx, New York, United States, 10456
Project Achieve - New York Blood Ctr - Women only
Bronx, New York, United States, 10456
Dutchess County Dept of Health
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, United States, 28207
PW Clinical Research / LLC
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Ohio State Univ / ACTU-Univ Clinic
Columbus, Ohio, United States, 43210
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Research and Education Group
Portland, Oregon, United States, 97210
United States, Pennsylvania
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19017
United States, Rhode Island
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Miriam Hosp
Providence, Rhode Island, United States, 02906
Omega Med Research
Providence, Rhode Island, United States, 02907
United States, Texas
Univ of Texas Med Branch Ctr for Clinical Studies
Galveston, Texas, United States, 77555
Nelson Tebedo Health Resource Ctr
Dallas, Texas, United States, 75219
UTMB Ctr for Clinical Studies / St John Prof Bldg
Houston, Texas, United States, 77058
Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
Dallas, Texas, United States, 75219
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
United States, Wisconsin
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, United States, 53203
Canada, British Columbia
St Pauls Hosp
Vancouver, British Columbia, Canada
Canada, Quebec
Ctr Hosp de Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Netherlands
Municipal Health Service
Amsterdam, Netherlands
Puerto Rico
Clinical Research of Puerto Rico Inc
San Juan, Puerto Rico, 00909
Sponsors and Collaborators
VaxGen
  More Information

No publications provided

Study ID Numbers: VAX 004
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002441     History of Changes
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:
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009