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

Last updated: June 23, 2005
Sponsor: VaxGen
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Aids And Aids Related Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT00002441
VAX 004
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 5000
Study Start date:
Estimated Completion Date:

Study 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.

Connect with a study center

  • St Pauls Hosp

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Ctr Hosp de Universite de Montreal (CHUM)

    Montreal, Quebec
    Canada

    Site Not Available

  • Municipal Health Service

    Amsterdam,
    Netherlands

    Site Not Available

  • Clinical Research of Puerto Rico Inc

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Univ of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Phoenix Body Positive

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arizona Clinical Research Ctr Inc

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Univ of California / UCI Med Ctr

    Orange, California 92868
    United States

    Site Not Available

  • ViRx Inc

    Palm Springs, California 92262
    United States

    Site Not Available

  • Univ of California - Davis Med Ctr / CARES

    Sacramento, California 95817
    United States

    Site Not Available

  • San Francisco Dept of Hlth / AIDS Office

    San Francisco, California 94102
    United States

    Site Not Available

  • San Francisco Gen Hosp

    San Francisco, California 941102859
    United States

    Site Not Available

  • UCSF - San Francisco Gen Hosp

    San Francisco, California 94110
    United States

    Site Not Available

  • Santa Clara Public Health Dept

    San Jose, California 95128
    United States

    Site Not Available

  • AIDS Research Alliance

    West Hollywood, California 90069
    United States

    Site Not Available

  • Denver Hlth and Hosp Authority / Dept of Pub Hlth

    Denver, Colorado 80204
    United States

    Site Not Available

  • Johns Hopkins Univ / Ctr for Immun Rsch

    Washington, District of Columbia 20003
    United States

    Site Not Available

  • IDC Research Initiative

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

  • Community AIDS Resource Inc

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Community AIDS Resource Inc

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Boulevard Comprehensive Care Ctr

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Community AIDS Resource Inc

    Riviera Beach, Florida 33404
    United States

    Site Not Available

  • Infectious Disease Research Institute

    Tampa, Florida 33614
    United States

    Site Not Available

  • Palm Beach Research Ctr

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Univ of Hawaii

    Honolulu, Hawaii 96816
    United States

    Site Not Available

  • Chicago Ctr for Clinical Research

    Chicago, Illinois 60610
    United States

    Site Not Available

  • Howard Brown Health Ctr

    Chicago, Illinois 60613
    United States

    Site Not Available

  • Univ of Illinois at Chicago / Dept of Medicine

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Community Hosp Indianapolis

    Indianapolis, Indiana 46219
    United States

    Site Not Available

  • Louisiana State Univ Med Ctr / Infect Diseases

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Fenway Community Health Ctr

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Abbott Northwestern Hosp

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Hennepin County Med Ctr

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Park Nicollet Med Ctr / Hlth Education

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • St Paul Public Health

    St. Paul, Minnesota 55101
    United States

    Site Not Available

  • Kansas City AIDS Research Consortium

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Louis Univ Hosp / Ctr for Vacc Dev

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Wellness Ctr / Las Vegas

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • New Jersey Community Research Initiative

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Univ of New Mexico Hlth Sciences Ctr / Dept of Med

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Albany Med College / Div of HIV Medicine

    Albany, New York 12208
    United States

    Site Not Available

  • New York Blood Ctr

    Bronx, New York 10456
    United States

    Site Not Available

  • Project Achieve - New York Blood Ctr - Women only

    Bronx, New York 10456
    United States

    Site Not Available

  • AIDS Services Erie County Med Ctr

    Buffalo, New York 14215
    United States

    Site Not Available

  • Mount Sinai Med Ctr / Jack Martin Fund Clinic

    New York, New York 10029
    United States

    Site Not Available

  • New York Univ Med Ctr / Dept of Environmental Med

    New York, New York 10016
    United States

    Site Not Available

  • St Luke Roosevelt Hosp

    New York, New York 10011
    United States

    Site Not Available

  • Dutchess County Dept of Health

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Univ of Rochester Med Ctr

    Rochester, New York 14642
    United States

    Site Not Available

  • Nalle Clinic / Clinical Research Dept

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • PW Clinical Research / LLC

    Winston Salem, North Carolina 27103
    United States

    Site Not Available

  • Case Western Reserve Univ

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio State Univ / ACTU-Univ Clinic

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Research and Education Group

    Portland, Oregon 97210
    United States

    Site Not Available

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania 19017
    United States

    Site Not Available

  • Univ of Pittsburgh Med School

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Mem Hosp of Rhode Island

    Pawtucket, Rhode Island 02860
    United States

    Site Not Available

  • Miriam Hosp

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Omega Med Research

    Providence, Rhode Island 02907
    United States

    Site Not Available

  • Nelson Tebedo Health Resource Ctr

    Dallas, Texas 75219
    United States

    Site Not Available

  • Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch

    Dallas, Texas 75219
    United States

    Site Not Available

  • Univ of Texas Med Branch Ctr for Clinical Studies

    Galveston, Texas 77555
    United States

    Site Not Available

  • UTMB Ctr for Clinical Studies / St John Prof Bldg

    Houston, Texas 77058
    United States

    Site Not Available

  • Univ of Washington

    Seattle, Washington 98104
    United States

    Site Not Available

  • Wisconsin AIDS Research Consortium

    Milwaukee, Wisconsin 53203
    United States

    Site Not Available

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