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A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients

23. juni 2005 opdateret af: Gilead Sciences

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml

The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients are randomized to 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.

Undersøgelsestype

Interventionel

Tilmelding

390

Fase

  • Ikke anvendelig

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 Paul's Hosp
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Centre hospitalier de l'Université de Montréal (CHUM)
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
        • King's College Hospital
      • London, Det Forenede Kongerige
        • Chelsea and Westminster Hosp
      • London, Det Forenede Kongerige
        • Royal Free Hosp
      • London, Det Forenede Kongerige
        • Senior Lecturer in GU Medicine
  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Pacific Oaks Research
      • Palm Springs, California, Forenede Stater, 92262
        • ViRx Inc
      • Sacramento, California, Forenede Stater, 95814
        • Ctr for AIDS Research / Education and Service (CARES)
      • San Francisco, California, Forenede Stater, 94110
        • San Francisco Gen Hosp / UCSF AIDS Program
      • San Francisco, California, Forenede Stater, 94121
        • San Francisco VA Med Ctr
      • San Francisco, California, Forenede Stater, 94118
        • Kaiser Foundation Hospital
    • Connecticut
      • Stamford, Connecticut, Forenede Stater, 06901
        • Blick Med Associates
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, Forenede Stater, 200091104
        • Dupont Circle Physicians Group
      • Washington, District of Columbia, Forenede Stater, 20007
        • Georgetown Univ Med Ctr
    • 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
        • TheraFirst Med Ctrs Inc
      • Jacksonville, Florida, Forenede Stater, 32206
        • Duval County Health Department
      • Safety Harbor, Florida, Forenede Stater, 34695
        • Health Positive
      • Tampa, Florida, Forenede Stater, 33609
        • Center for Quality Care
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Georgia Research Associates
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana Univ Infectious Disease Research Clinic
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins Univ School of Medicine
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Albany Med College
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Med Ctr
      • New York, New York, Forenede Stater, 10011
        • Bentley-Salick Med Practice
      • New York, New York, Forenede Stater, 10011
        • St Luke Roosevelt Hosp
      • New York, New York, Forenede Stater, 10019
        • James Jones MD
    • North Carolina
      • Winston Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest Univ School of Medicine
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74114
        • Associates of Med and Mental Health
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • The Research and Education Group
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Miriam Hosp
      • Providence, Rhode Island, Forenede Stater, 02908
        • Roger Williams Med Ctr
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37212
        • Vanderbilt Univ School of Medicine
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Galveston, Texas, Forenede Stater, 77555
        • Univ of Texas Med Branch
      • Houston, Texas, Forenede Stater, 77009
        • Thomas Street Clinic
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84108
        • Univ of Utah Med School / Clinical Trials Ctr
    • Virginia
      • Annandale, Virginia, Forenede Stater, 22203
        • Infectious Disease Physicians Inc
    • Washington
      • Seattle, Washington, Forenede Stater, 98122
        • N Touch Research Corp
  • Frankrig
      • Lyon Cedex 03, Frankrig
        • Hôpital Edouard Herriot
      • Marseille, Frankrig
        • Hôpital Sainte-Marguerite
  • Tyskland
      • Frankfurt, Tyskland
        • Klinikum Der Johann Wolfgang Goethe Universitat
      • Hamburg, Tyskland
        • Universitätskrankenhaus Eppendorf
      • Muenchen, Tyskland
        • Klinikum der Ludwig-Maximilians-Universitaet

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

1 sekund og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry.
  • Have a CD4 count of 50 cells/mm3 or more.
  • Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry.
  • Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Maskning: Dobbelt

Samarbejdspartnere og efterforskere

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

Sponsor

Gilead Sciences

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. december 1999

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 232K
  • GS-97-415

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 .

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