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

Completed · Phase 3

Conditions studied: HIV Infections, HIV Seronegativity

In brief

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.

Key facts

Study ID

NCT00002441

Run by

VaxGen

People needed

5000

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.)

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, United States
• Arizona Clinical Research Ctr Inc — Tucson, Arizona, United States
• Univ of California / UCI Med Ctr — Orange, California, United States
• ViRx Inc — Palm Springs, California, United States
• Univ of California - Davis Med Ctr / CARES — Sacramento, California, United States
• San Francisco Dept of Hlth / AIDS Office — San Francisco, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Santa Clara Public Health Dept — San Jose, California, United States
• AIDS Research Alliance — West Hollywood, California, United States
• Denver Hlth and Hosp Authority / Dept of Pub Hlth — Denver, Colorado, United States
• Johns Hopkins Univ / Ctr for Immun Rsch — Washington D.C., District of Columbia, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Community AIDS Resource Inc — Coral Gables, Florida, United States
• Community AIDS Resource Inc — Fort Lauderdale, Florida, United States
• Boulevard Comprehensive Care Ctr — Jacksonville, Florida, United States
• Community AIDS Resource Inc — Riviera Beach, Florida, United States
• Infectious Disease Research Institute — Tampa, Florida, United States
• Palm Beach Research Ctr — West Palm Beach, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Chicago Ctr for Clinical Research — Chicago, Illinois, United States
• Univ of Illinois at Chicago / Dept of Medicine — Chicago, Illinois, United States
• Howard Brown Health Ctr — Chicago, Illinois, United States
• Univ of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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