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

NCT ID: NCT00002441

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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HIV Infections HIV Seronegativity

Study Design

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Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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MN rgp120/HIV-1 and GNE8 rgp120/HIV-1

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VaxGen

INDUSTRY

Sponsor Role lead

Locations

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Project Achieve - New York Blood Ctr - Women only

The Bronx, New York, United States

Site Status

Nalle Clinic / Clinical Research Dept

Charlotte, North Carolina, United States

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PW Clinical Research / LLC

Winston-Salem, North Carolina, United States

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

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Phoenix Body Positive

Phoenix, Arizona, United States

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Arizona Clinical Research Ctr Inc

Tucson, Arizona, United States

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Univ of California / UCI Med Ctr

Orange, California, United States

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ViRx Inc

Palm Springs, California, United States

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Univ of California - Davis Med Ctr / CARES

Sacramento, California, United States

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San Francisco Dept of Hlth / AIDS Office

San Francisco, California, United States

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San Francisco Gen Hosp

San Francisco, California, United States

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UCSF - San Francisco Gen Hosp

San Francisco, California, United States

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Santa Clara Public Health Dept

San Jose, California, United States

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AIDS Research Alliance

West Hollywood, California, United States

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Denver Hlth and Hosp Authority / Dept of Pub Hlth

Denver, Colorado, United States

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Johns Hopkins Univ / Ctr for Immun Rsch

Washington D.C., District of Columbia, United States

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IDC Research Initiative

Altamonte Springs, Florida, United States

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Community AIDS Resource Inc

Coral Gables, Florida, United States

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Community AIDS Resource Inc

Fort Lauderdale, Florida, United States

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Boulevard Comprehensive Care Ctr

Jacksonville, Florida, United States

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Community AIDS Resource Inc

Riviera Beach, Florida, United States

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Infectious Disease Research Institute

Tampa, Florida, United States

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Palm Beach Research Ctr

West Palm Beach, Florida, United States

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AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

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Univ of Hawaii

Honolulu, Hawaii, United States

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Chicago Ctr for Clinical Research

Chicago, Illinois, United States

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Univ of Illinois at Chicago / Dept of Medicine

Chicago, Illinois, United States

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Howard Brown Health Ctr

Chicago, Illinois, United States

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Community Hosp Indianapolis

Indianapolis, Indiana, United States

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Louisiana State Univ Med Ctr / Infect Diseases

New Orleans, Louisiana, United States

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Fenway Community Health Ctr

Boston, Massachusetts, United States

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Abbott Northwestern Hosp

Minneapolis, Minnesota, United States

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Hennepin County Med Ctr

Minneapolis, Minnesota, United States

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Park Nicollet Med Ctr / Hlth Education

Saint Louis Park, Minnesota, United States

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St Paul Public Health

Saint Paul, Minnesota, United States

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Kansas City AIDS Research Consortium

Kansas City, Missouri, United States

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Saint Louis Univ Hosp / Ctr for Vacc Dev

St Louis, Missouri, United States

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Wellness Ctr / Las Vegas

Las Vegas, Nevada, United States

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New Jersey Community Research Initiative

Newark, New Jersey, United States

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Univ of New Mexico Hlth Sciences Ctr / Dept of Med

Albuquerque, New Mexico, United States

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Albany Med College / Div of HIV Medicine

Albany, New York, United States

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Case Western Reserve Univ

Cleveland, Ohio, United States

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AIDS Services Erie County Med Ctr

Buffalo, New York, United States

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St Luke Roosevelt Hosp

New York, New York, United States

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New York Univ Med Ctr / Dept of Environmental Med

New York, New York, United States

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Mount Sinai Med Ctr / Jack Martin Fund Clinic

New York, New York, United States

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Dutchess County Dept of Health

Poughkeepsie, New York, United States

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Univ of Rochester Med Ctr

Rochester, New York, United States

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New York Blood Ctr

The Bronx, New York, United States

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Ohio State Univ / ACTU-Univ Clinic

Columbus, Ohio, United States

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Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg

Tulsa, Oklahoma, United States

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Research and Education Group

Portland, Oregon, United States

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Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

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Univ of Pittsburgh Med School

Pittsburgh, Pennsylvania, United States

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Mem Hosp of Rhode Island

Pawtucket, Rhode Island, United States

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Miriam Hosp

Providence, Rhode Island, United States

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Omega Med Research

Providence, Rhode Island, United States

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Nelson Tebedo Health Resource Ctr

Dallas, Texas, United States

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

Dallas, Texas, United States

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Univ of Texas Med Branch Ctr for Clinical Studies

Galveston, Texas, United States

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UTMB Ctr for Clinical Studies / St John Prof Bldg

Houston, Texas, United States

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Univ of Washington

Seattle, Washington, United States

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Wisconsin AIDS Research Consortium

Milwaukee, Wisconsin, United States

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St Pauls Hosp

Vancouver, British Columbia, Canada

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Ctr Hosp de Universite de Montreal (CHUM)

Montreal, Quebec, Canada

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Municipal Health Service

Amsterdam, , Netherlands

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Clinical Research of Puerto Rico Inc

San Juan, , Puerto Rico

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Countries

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United States Canada Netherlands Puerto Rico

Other Identifiers

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VAX 004

Identifier Type: -

Identifier Source: org_study_id