Clinical trial NCT00002441: Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
HIV Seronegativity
Keywords: HIV-1
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
AIDS Vaccines
Sexually Transmitted Diseases
Risk Factors
HIV Seronegativity
Antigens, Viral
Alum Compounds
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

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.

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 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.)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Ctr Inc
state: Arizona
city: Orange
country: United States
facility: Univ of California / UCI Med Ctr
state: California
city: Palm Springs
country: United States
facility: ViRx Inc
state: California
city: Sacramento
country: United States
facility: Univ of California - Davis Med Ctr / CARES
state: California
city: San Francisco
country: United States
facility: San Francisco Dept of Hlth / AIDS Office
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: San Jose
country: United States
facility: Santa Clara Public Health Dept
state: California
city: West Hollywood
country: United States
facility: AIDS Research Alliance
state: California
city: Denver
country: United States
facility: Denver Hlth and Hosp Authority / Dept of Pub Hlth
state: Colorado
city: Washington
country: United States
facility: Johns Hopkins Univ / Ctr for Immun Rsch
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Coral Gables
country: United States
facility: Community AIDS Resource Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: Community AIDS Resource Inc
state: Florida
city: Jacksonville
country: United States
facility: Boulevard Comprehensive Care Ctr
state: Florida
city: Riviera Beach
country: United States
facility: Community AIDS Resource Inc
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Ctr
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Honolulu
country: United States
facility: Univ of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Univ of Illinois at Chicago / Dept of Medicine
state: Illinois
city: Chicago
country: United States
facility: Howard Brown Health Ctr
state: Illinois
city: Indianapolis
country: United States
facility: Community Hosp Indianapolis
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State Univ Med Ctr / Infect Diseases
state: Louisiana
city: Boston
country: United States
facility: Fenway Community Health Ctr
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hosp
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Med Ctr
state: Minnesota
city: St. Louis Park
country: United States
facility: Park Nicollet Med Ctr / Hlth Education
state: Minnesota
city: St. Paul
country: United States
facility: St Paul Public Health
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City AIDS Research Consortium
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis Univ Hosp / Ctr for Vacc Dev
state: Missouri
city: Las Vegas
country: United States
facility: Wellness Ctr / Las Vegas
state: Nevada
city: Newark
country: United States
facility: New Jersey Community Research Initiative
state: New Jersey
city: Albuquerque
country: United States
facility: Univ of New Mexico Hlth Sciences Ctr / Dept of Med
state: New Mexico
city: Albany
country: United States
facility: Albany Med College / Div of HIV Medicine
state: New York
city: Bronx
country: United States
facility: New York Blood Ctr
state: New York
city: Bronx
country: United States
facility: Project Achieve - New York Blood Ctr - Women only
state: New York
city: Buffalo
country: United States
facility: AIDS Services Erie County Med Ctr
state: New York
city: New York
country: United States
facility: St Luke Roosevelt Hosp
state: New York
city: New York
country: United States
facility: New York Univ Med Ctr / Dept of Environmental Med
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr / Jack Martin Fund Clinic
state: New York
city: Poughkeepsie
country: United States
facility: Dutchess County Dept of Health
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Charlotte
country: United States
facility: Nalle Clinic / Clinical Research Dept
state: North Carolina
city: Winston Salem
country: United States
facility: PW Clinical Research / LLC
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve Univ
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ / ACTU-Univ Clinic
state: Ohio
city: Tulsa
country: United States
facility: Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
state: Oklahoma
city: Portland
country: United States
facility: Research and Education Group
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh Med School
state: Pennsylvania
city: Pawtucket
country: United States
facility: Mem Hosp of Rhode Island
state: Rhode Island
city: Providence
country: United States
facility: Miriam Hosp
state: Rhode Island
city: Providence
country: United States
facility: Omega Med Research
state: Rhode Island
city: Dallas
country: United States
facility: Nelson Tebedo Health Resource Ctr
state: Texas
city: Dallas
country: United States
facility: Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
state: Texas
city: Galveston
country: United States
facility: Univ of Texas Med Branch Ctr for Clinical Studies
state: Texas
city: Houston
country: United States
facility: UTMB Ctr for Clinical Studies / St John Prof Bldg
state: Texas
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin AIDS Research Consortium
state: Wisconsin
city: Vancouver
country: Canada
facility: St Pauls Hosp
state: British Columbia
city: Montreal
country: Canada
facility: Ctr Hosp de Universite de Montreal (CHUM)
state: Quebec
city: Amsterdam
country: Netherlands
facility: Municipal Health Service
city: San Juan
country: Puerto Rico
facility: Clinical Research of Puerto Rico Inc
Study officials:
References: