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



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

For Condition: HIV Infections,HIV Seronegativity
Status: Completed
Sponsor(s): VaxGen ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Prevention, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.)
Total Enrollment: 5000

Location and Contact Information:

Univ of Illinois at Chicago / Dept of Medicine
Chicago,  Illinois,  60612
United States
 

Miriam Hosp
Providence,  Rhode Island,  02906
United States
 

Research and Education Group
Portland,  Oregon,  97210
United States
 

Abbott Northwestern Hosp
Minneapolis,  Minnesota,  55407
United States
 

Wellness Ctr / Las Vegas
Las Vegas,  Nevada,  89102
United States
 

Howard Brown Health Ctr
Chicago,  Illinois,  60613
United States
 

Hennepin County Med Ctr
Minneapolis,  Minnesota,  55415
United States
 

Univ of Washington
Seattle,  Washington,  98104
United States
 

Univ of Texas Med Branch Ctr for Clinical Studies
Galveston,  Texas,  77555
United States
 

Phoenix Body Positive
Phoenix,  Arizona,  85016
United States
 

Dutchess County Dept of Health
Poughkeepsie,  New York,  12601
United States
 

PW Clinical Research / LLC
Winston Salem,  North Carolina,  27103
United States
 

Boulevard Comprehensive Care Ctr
Jacksonville,  Florida,  32209
United States
 

Saint Louis Univ Hosp / Ctr for Vacc Dev
St. Louis,  Missouri,  63104
United States
 

Mount Sinai Med Ctr / Jack Martin Fund Clinic
New York City,  New York,  10029
United States
 

Mem Hosp of Rhode Island
Pawtucket,  Rhode Island,  02860
United States
 

Ctr Hosp de Universite de Montreal (CHUM)
Montreal,  Quebec, 
Canada
 

Case Western Reserve Univ
Cleveland,  Ohio,  44106
United States
 

Univ of Rochester Med Ctr
Rochester,  New York,  14642
United States
 

Omega Med Research
Providence,  Rhode Island,  02907
United States
 

New York Blood Ctr
Bronx,  New York,  10456
United States
 

Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
Tulsa,  Oklahoma,  74104
United States
 

Nelson Tebedo Health Resource Ctr
Dallas,  Texas,  75219
United States
 

Palm Beach Research Ctr
West Palm Beach,  Florida,  33409
United States
 

Univ of Pittsburgh Med School
Pittsburgh,  Pennsylvania, 
United States
 

AIDS Research Alliance
West Hollywood,  California,  90069
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Clinical Research of Puerto Rico Inc
San Juan,  ,  00909
Puerto Rico
 

Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque,  New Mexico,  87131
United States
 

St Pauls Hosp
Vancouver,  British Columbia, 
Canada
 

Univ of California - Davis Med Ctr / CARES
Sacramento,  California,  95817
United States
 

AIDS Services Erie County Med Ctr
Buffalo,  New York,  14215
United States
 

UTMB Ctr for Clinical Studies / St John Prof Bldg
Houston,  Texas,  77058
United States
 

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

New York Univ Med Ctr / Dept of Environmental Med
New York City,  New York,  10016
United States
 

UCSF - San Francisco Gen Hosp
San Francisco,  California,  94110
United States
 

IDC Research Initiative
Altamonte Springs,  Florida,  32701
United States
 

New Jersey Community Research Initiative
Newark,  New Jersey,  07103
United States
 

Louisiana State Univ Med Ctr / Infect Diseases
New Orleans,  Louisiana,  70112
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Park Nicollet Med Ctr / Hlth Education
St. Louis Park,  Minnesota,  55416
United States
 

Community AIDS Resource Inc
Coral Gables,  Florida,  33146
United States
 

Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
Dallas,  Texas,  75219
United States
 

Project Achieve - New York Blood Ctr - Women only
Bronx,  New York,  10456
United States
 

Santa Clara Public Health Dept
San Jose,  California,  95128
United States
 

Johns Hopkins Univ / Ctr for Immun Rsch
Washington D.C.,  District of Columbia,  20003
United States
 

ViRx Inc
Palm Springs,  California,  92262
United States
 

Philadelphia FIGHT
Philadelphia,  Pennsylvania,  19017
United States
 

Community AIDS Resource Inc
Riviera Beach,  Florida,  33404
United States
 

Nalle Clinic / Clinical Research Dept
Charlotte,  North Carolina,  28207
United States
 

Wisconsin AIDS Research Consortium
Milwaukee,  Wisconsin,  53203
United States
 

Fenway Community Health Ctr
Boston,  Massachusetts,  02115
United States
 

Community Hosp Indianapolis
Indianapolis,  Indiana,  46219
United States
 

Community AIDS Resource Inc
Ft. Lauderdale,  Florida,  33308
United States
 

Denver Hlth and Hosp Authority / Dept of Pub Hlth
Denver,  Colorado,  80204
United States
 

Municipal Health Service
Amsterdam,  , 
Netherlands
 

St Paul Public Health
St. Paul,  Minnesota,  55101
United States
 

Kansas City AIDS Research Consortium
Kansas City,  Missouri,  64111
United States
 

Univ of California / UCI Med Ctr
Orange,  California,  92868
United States
 

Infectious Disease Research Institute
Tampa,  Florida,  33614
United States
 

Ohio State Univ / ACTU-Univ Clinic
Columbus,  Ohio,  43210
United States
 

San Francisco Dept of Hlth / AIDS Office
San Francisco,  California,  94102
United States
 

St Luke Roosevelt Hosp
New York City,  New York,  10011
United States
 

Arizona Clinical Research Ctr Inc
Tucson,  Arizona,  85712
United States
 

Chicago Ctr for Clinical Research
Chicago,  Illinois,  60610
United States
 

Albany Med College / Div of HIV Medicine
Albany,  New York,  12208
United States
 


Additional Information:
Study ID Numbers:
  VAX 004; 
Study Start Date: 
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002441

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