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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding

5000

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Maskning: Dobbelt

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VaxGen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Datoer for studieregistrering

Først indsendt

2. november 1999

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2005

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2005

Sidst verificeret

1. januar 2000

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VAX 004

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med MN rgp120/HIV-1 og GNE8 rgp120/HIV-1

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Turkmenistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner