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

23. juni 2005 oppdatert av: VaxGen

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

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering

5000

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St Pauls Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Ctr Hosp de Universite de Montreal (CHUM)
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • Univ of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Forente stater, 85016
        • Phoenix Body Positive
      • Tucson, Arizona, Forente stater, 85712
        • Arizona Clinical Research Ctr Inc
    • California
      • Orange, California, Forente stater, 92868
        • Univ of California / UCI Med Ctr
      • Palm Springs, California, Forente stater, 92262
        • ViRx Inc
      • Sacramento, California, Forente stater, 95817
        • Univ of California - Davis Med Ctr / CARES
      • San Francisco, California, Forente stater, 941102859
        • San Francisco Gen Hosp
      • San Francisco, California, Forente stater, 94110
        • UCSF - San Francisco Gen Hosp
      • San Francisco, California, Forente stater, 94102
        • San Francisco Dept of Hlth / AIDS Office
      • San Jose, California, Forente stater, 95128
        • Santa Clara Public Health Dept
      • West Hollywood, California, Forente stater, 90069
        • AIDS Research Alliance
    • Colorado
      • Denver, Colorado, Forente stater, 80204
        • Denver Hlth and Hosp Authority / Dept of Pub Hlth
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20003
        • Johns Hopkins Univ / Ctr for Immun Rsch
    • Florida
      • Altamonte Springs, Florida, Forente stater, 32701
        • IDC Research Initiative
      • Coral Gables, Florida, Forente stater, 33146
        • Community AIDS Resource Inc
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Community AIDS Resource Inc
      • Jacksonville, Florida, Forente stater, 32209
        • Boulevard Comprehensive Care Ctr
      • Riviera Beach, Florida, Forente stater, 33404
        • Community AIDS Resource Inc
      • Tampa, Florida, Forente stater, 33614
        • Infectious Disease Research Institute
      • West Palm Beach, Florida, Forente stater, 33409
        • Palm Beach Research Ctr
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308
        • AIDS Research Consortium of Atlanta
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96816
        • Univ of Hawaii
    • Illinois
      • Chicago, Illinois, Forente stater, 60610
        • Chicago Ctr for Clinical Research
      • Chicago, Illinois, Forente stater, 60613
        • Howard Brown Health Ctr
      • Chicago, Illinois, Forente stater, 60612
        • Univ of Illinois at Chicago / Dept of Medicine
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46219
        • Community Hosp Indianapolis
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Louisiana State Univ Med Ctr / Infect Diseases
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Fenway Community Health Ctr
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Med Ctr
      • Minneapolis, Minnesota, Forente stater, 55407
        • Abbott Northwestern Hosp
      • St. Louis Park, Minnesota, Forente stater, 55416
        • Park Nicollet Med Ctr / Hlth Education
      • St. Paul, Minnesota, Forente stater, 55101
        • St Paul Public Health
    • Missouri
      • Kansas City, Missouri, Forente stater, 64111
        • Kansas City AIDS Research Consortium
      • Saint Louis, Missouri, Forente stater, 63104
        • Saint Louis Univ Hosp / Ctr for Vacc Dev
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89102
        • Wellness Ctr / Las Vegas
    • New Jersey
      • Newark, New Jersey, Forente stater, 07103
        • New Jersey Community Research Initiative
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87131
        • Univ of New Mexico Hlth Sciences Ctr / Dept of Med
    • New York
      • Albany, New York, Forente stater, 12208
        • Albany Med College / Div of HIV Medicine
      • Bronx, New York, Forente stater, 10456
        • New York Blood Ctr
      • Bronx, New York, Forente stater, 10456
        • Project Achieve - New York Blood Ctr - Women only
      • Buffalo, New York, Forente stater, 14215
        • AIDS Services Erie County Med Ctr
      • New York, New York, Forente stater, 10011
        • St Luke Roosevelt Hosp
      • New York, New York, Forente stater, 10029
        • Mount Sinai Med Ctr / Jack Martin Fund Clinic
      • New York, New York, Forente stater, 10016
        • New York Univ Med Ctr / Dept of Environmental Med
      • Poughkeepsie, New York, Forente stater, 12601
        • Dutchess County Dept of Health
      • Rochester, New York, Forente stater, 14642
        • Univ of Rochester Med Ctr
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28207
        • Nalle Clinic / Clinical Research Dept
      • Winston Salem, North Carolina, Forente stater, 27103
        • PW Clinical Research / LLC
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Case Western Reserve Univ
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State Univ / ACTU-Univ Clinic
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
        • Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • Research and Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19017
        • Philadelphia FIGHT
      • Pittsburgh, Pennsylvania, Forente stater
        • Univ of Pittsburgh Med School
    • Rhode Island
      • Pawtucket, Rhode Island, Forente stater, 02860
        • Mem Hosp of Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • Miriam Hosp
      • Providence, Rhode Island, Forente stater, 02907
        • Omega Med Research
    • Texas
      • Dallas, Texas, Forente stater, 75219
        • Nelson Tebedo Health Resource Ctr
      • Dallas, Texas, Forente stater, 75219
        • Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
      • Galveston, Texas, Forente stater, 77555
        • Univ of Texas Med Branch Ctr for Clinical Studies
      • Houston, Texas, Forente stater, 77058
        • UTMB Ctr for Clinical Studies / St John Prof Bldg
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Univ of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53203
        • Wisconsin AIDS Research Consortium
  • Nederland
      • Amsterdam, Nederland
        • Municipal Health Service
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Clinical Research of Puerto Rico Inc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Masking: Dobbelt

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

VaxGen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Datoer for studieregistrering

Først innsendt

2. november 1999

Først innsendt som oppfylte QC-kriteriene

30. august 2001

Først lagt ut (Anslag)

31. august 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. juni 2005

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2005

Sist bekreftet

1. januar 2000

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VAX 004

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere