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| Sponsor: | VaxGen |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002441 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections HIV Seronegativity |
Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Double-Blind, Safety Study |
| 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 |
| Estimated Enrollment: | 5000 |
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Exclusion Criteria
You will not be eligible for this study if you:
You may be eligible for this study if you:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Phoenix Body Positive | |
| Phoenix, Arizona, United States, 85016 | |
| Arizona Clinical Research Ctr Inc | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| AIDS Research Alliance | |
| West Hollywood, California, United States, 90069 | |
| Univ of California / UCI Med Ctr | |
| Orange, California, United States, 92868 | |
| San Francisco Dept of Hlth / AIDS Office | |
| San Francisco, California, United States, 94102 | |
| Univ of California - Davis Med Ctr / CARES | |
| Sacramento, California, United States, 95817 | |
| ViRx Inc | |
| Palm Springs, California, United States, 92262 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| Santa Clara Public Health Dept | |
| San Jose, California, United States, 95128 | |
| United States, Colorado | |
| Denver Hlth and Hosp Authority / Dept of Pub Hlth | |
| Denver, Colorado, United States, 80204 | |
| United States, District of Columbia | |
| Johns Hopkins Univ / Ctr for Immun Rsch | |
| Washington, District of Columbia, United States, 20003 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Palm Beach Research Ctr | |
| West Palm Beach, Florida, United States, 33409 | |
| Infectious Disease Research Institute | |
| Tampa, Florida, United States, 33614 | |
| Boulevard Comprehensive Care Ctr | |
| Jacksonville, Florida, United States, 32209 | |
| Community AIDS Resource Inc | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Community AIDS Resource Inc | |
| Coral Gables, Florida, United States, 33146 | |
| Community AIDS Resource Inc | |
| Riviera Beach, Florida, United States, 33404 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Hawaii | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Chicago Ctr for Clinical Research | |
| Chicago, Illinois, United States, 60610 | |
| Univ of Illinois at Chicago / Dept of Medicine | |
| Chicago, Illinois, United States, 60612 | |
| Howard Brown Health Ctr | |
| Chicago, Illinois, United States, 60613 | |
| United States, Indiana | |
| Community Hosp Indianapolis | |
| Indianapolis, Indiana, United States, 46219 | |
| United States, Louisiana | |
| Louisiana State Univ Med Ctr / Infect Diseases | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Fenway Community Health Ctr | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Abbott Northwestern Hosp | |
| Minneapolis, Minnesota, United States, 55407 | |
| Hennepin County Med Ctr | |
| Minneapolis, Minnesota, United States, 55415 | |
| St Paul Public Health | |
| St. Paul, Minnesota, United States, 55101 | |
| Park Nicollet Med Ctr / Hlth Education | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| Saint Louis Univ Hosp / Ctr for Vacc Dev | |
| Saint Louis, Missouri, United States, 63104 | |
| Kansas City AIDS Research Consortium | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nevada | |
| Wellness Ctr / Las Vegas | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| New Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 07103 | |
| United States, New Mexico | |
| Univ of New Mexico Hlth Sciences Ctr / Dept of Med | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Univ of Rochester Med Ctr | |
| Rochester, New York, United States, 14642 | |
| Albany Med College / Div of HIV Medicine | |
| Albany, New York, United States, 12208 | |
| New York Univ Med Ctr / Dept of Environmental Med | |
| New York, New York, United States, 10016 | |
| AIDS Services Erie County Med Ctr | |
| Buffalo, New York, United States, 14215 | |
| Mount Sinai Med Ctr / Jack Martin Fund Clinic | |
| New York, New York, United States, 10029 | |
| St Luke Roosevelt Hosp | |
| New York, New York, United States, 10011 | |
| New York Blood Ctr | |
| Bronx, New York, United States, 10456 | |
| Project Achieve - New York Blood Ctr - Women only | |
| Bronx, New York, United States, 10456 | |
| Dutchess County Dept of Health | |
| Poughkeepsie, New York, United States, 12601 | |
| United States, North Carolina | |
| Nalle Clinic / Clinical Research Dept | |
| Charlotte, North Carolina, United States, 28207 | |
| PW Clinical Research / LLC | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Ohio State Univ / ACTU-Univ Clinic | |
| Columbus, Ohio, United States, 43210 | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oklahoma | |
| Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Research and Education Group | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Univ of Pittsburgh Med School | |
| Pittsburgh, Pennsylvania, United States | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19017 | |
| United States, Rhode Island | |
| Mem Hosp of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| Omega Med Research | |
| Providence, Rhode Island, United States, 02907 | |
| United States, Texas | |
| Univ of Texas Med Branch Ctr for Clinical Studies | |
| Galveston, Texas, United States, 77555 | |
| Nelson Tebedo Health Resource Ctr | |
| Dallas, Texas, United States, 75219 | |
| UTMB Ctr for Clinical Studies / St John Prof Bldg | |
| Houston, Texas, United States, 77058 | |
| Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch | |
| Dallas, Texas, United States, 75219 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Wisconsin AIDS Research Consortium | |
| Milwaukee, Wisconsin, United States, 53203 | |
| Canada, British Columbia | |
| St Pauls Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Quebec | |
| Ctr Hosp de Universite de Montreal (CHUM) | |
| Montreal, Quebec, Canada | |
| Netherlands | |
| Municipal Health Service | |
| Amsterdam, Netherlands | |
| Puerto Rico | |
| Clinical Research of Puerto Rico Inc | |
| San Juan, Puerto Rico, 00909 | |
More Information
| Study ID Numbers: | VAX 004 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002441 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Dose-Response Relationship, Drug Acquired Immunodeficiency Syndrome AIDS Vaccines Sexually Transmitted Diseases |
Risk Factors HIV Seronegativity Antigens, Viral Alum Compounds |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |