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Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)

10. september 2010 opdateret af: Bristol-Myers Squibb

A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)

This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study is designed to determine the metabolic changes, antiviral activity, safety, and tolerability of atazanavir as compared to LPV/RTV, each in combination with 2 nucleosides, over the initial 24 weeks, with a final analysis at 48 weeks.

Undersøgelsestype

Interventionel

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

        • Aurora hospital
        • Department of Infection & Tropical Medicine
        • Klinicka Chorobzkaznych AM
  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano
      • Buenos Aires, Argentina
        • Fundacion Huesped
      • Buenos Aires, Argentina
        • Claudia Rodriguez MD
      • Buenos Aires, Argentina
        • Elida Pallone MD
      • Rosario Santa Fe, Argentina
        • CAICI
  • Australien
      • Prahan, Australien
        • Alfred Hosp
      • South Yarra, Australien
        • Prahran Market Clinic
      • Sydney, Australien
        • Taylors Square Clinic
      • Sydney, Australien
        • Saint Vincent's Hosp Med Centre
  • Belgien
      • Antwerpe, Belgien
        • Inst of Tropical Medicine
      • Brussels, Belgien
        • CHU Saint Pierre
      • Bruxelles, Belgien
        • Cliniques Universitaires Saint Luc
      • Gent, Belgien
        • University Hospital Gent
      • Liege, Belgien
        • Domaine Universitaire Du SART-TILMAN
  • Brasilien
      • Curitiba, Brasilien
        • Hospital de Clínicas da Universidade Federal do Paraná
      • Porto Alegre, Brasilien
        • Hospital Nossa Senhora da Conceicao-GCH
      • Sao Paulo, Brasilien
        • Instituto de Infectologia Emilio Ribas
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Gen Hosp / Div of Clin Immuno and Allergy
      • Montreal, Quebec, Canada
        • Clinique Medicale du Quartier Latin
      • Montreal, Quebec, Canada
        • Dr Roger P Leblanc
  • Chile
      • Santiago, Chile
        • Fundacion Arriaran
      • Santiago, Chile
        • Hosp Sotero de Rio
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige
        • Whittal Street Clinic
      • Liverpool, Det Forenede Kongerige
        • Royal Liverpool Univ Hosp
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Cooper Green Hosp
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Phoenix Body Positive
    • California
      • Berkeley, California, Forenede Stater, 94705
        • East Bay AIDS Ctr
      • San Francisco, California, Forenede Stater, 94121
        • San Francisco Veterans Administration Med Ctr
      • San Francisco, California, Forenede Stater, 94118
        • Kaiser Foundation Hospital
      • San Francisco, California, Forenede Stater, 94109
        • Saint Francis Mem Hosp / HIV Care Unit
      • Torrance, California, Forenede Stater, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • Beacon Clinic / Boulder Community Hosp
    • Florida
      • Altamonte Springs, Florida, Forenede Stater, 32701
        • IDC Research Initiative
      • Atlantis, Florida, Forenede Stater, 33462
        • Larry Bush
      • Fort Lauderdale, Florida, Forenede Stater, 33306
        • Community Health care
      • Miami Beach, Florida, Forenede Stater, 33160
        • South Beach Medical Associates
      • Orlando, Florida, Forenede Stater, 32801
        • Florida ID Group
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30033
        • Infectious Disease Specialists of Atlanta
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96816
        • Univ of Hawaii
    • Idaho
      • Boise, Idaho, Forenede Stater, 83704
        • Sky Blue
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46218
        • Infectious Disease of Indiana
    • Kansas
      • Wichita, Kansas, Forenede Stater, 672143124
        • Univ of Kansas School of Medicine
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Univ of Kentucky Med Ctr
    • Massachusetts
      • Brookline, Massachusetts, Forenede Stater, 02445
        • Community Research Initiative
      • Worcester, Massachusetts, Forenede Stater, 01655
        • Univ of Massachusetts
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63139
        • Southampton Healthcare Inc
    • Nevada
      • Reno, Nevada, Forenede Stater, 89502
        • Steven Zell
    • New Jersey
      • East Orange, New Jersey, Forenede Stater, 07018
        • VAMC New Jersey Healthcare System
      • Newark, New Jersey, Forenede Stater, 071032842
        • North Jersey Community Research Initiative
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Albany Med College
      • Buffalo, New York, Forenede Stater, 14215
        • Erie County Med Ctr
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore Univ Hosp
      • Rochester, New York, Forenede Stater, 14620
        • Community Health Network
    • North Carolina
      • Huntersville, North Carolina, Forenede Stater, 28078
        • Jemsek Clinic
    • Oregon
      • Portland, Oregon, Forenede Stater, 97201
        • Oregon Health Sciences Univ
      • Portland, Oregon, Forenede Stater, 97209
        • Research & Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Mark Watkins
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • Univ of South Carolina School of Medicine
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Nicholas Bellos
      • Dallas, Texas, Forenede Stater, 75208
        • North Texas Center for AIDS & Clinical Research
      • Houston, Texas, Forenede Stater, 77006
        • Houston Clinical Research Network
      • Houston, Texas, Forenede Stater, 77030
        • Infectious Diseases Associates of Houston
  • Frankrig
      • Lyon, Frankrig
        • Hopital Hotel Dieu de Lyon
      • Paris, Frankrig
        • CHU de Bicetre
      • Paris, Frankrig
        • Hopital Cochin - Port Royal
      • Paris Cedex 12, Frankrig
        • Services des Maladies Infectieuses
      • Tourcoing, Frankrig
        • Hôpital Gustave Dron
  • Holland
      • CX Utrecht, Holland
        • Univ Medical Center Utrecht
  • Italien
      • Bologna, Italien
        • Ospedale S Orsola
      • Cagliari, Italien
        • Immunoligia Universita Cagliari
      • Corso Svizzera, Italien
        • Reparto di Malattie Infettive
      • Milano, Italien
        • Ospedale Luigi Sacco Cargnel
      • Milano, Italien
        • Ospedale S Raffaele
      • Rimini, Italien
        • Ospedale Degli Infermi
      • Roma, Italien
        • Cat All Immun Clin
      • Torino, Italien
        • Ospedale Amedeo di Savoia
      • Torino, Italien
        • Ospedale Amedeo de Savoia
  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de la Nutricion
      • Mexico City, Mexico
        • Hospital Regional
      • Mexico City, Mexico
        • Hospital General
      • Mexico City, Mexico
        • Hospital 1 ro de Octubre
  • Peru
      • Lima, Peru
        • Hosp Guillermo Almenara-Medicina 1
      • Lima, Peru
        • Hosp Nacional Cayetano Heredia
  • Puerto Rico
      • Coto Laurel, Ponce, Puerto Rico, 00780
        • San Cristobal Hosp
      • San Juan, Puerto Rico, 009091711
        • Clinical Research Puerto Rico Inc
  • Spanien
      • Barcelona, Spanien
        • Hospital Germans Trias i Pujol
      • Barcelona, Spanien
        • Hosp Clinic
      • Bilboa, Spanien
        • Hosp de Basurto / Enfermedades Infecciosas
      • Cordoba, Spanien
        • Hosp Reina Sofia
      • Madrid, Spanien
        • Hosp Carlos III
      • Madris, Spanien
        • Hosp Ramon y Cajal
      • Oviedo, Spanien
        • Hosp Nuestra Senora de Covadonga
      • Sevilla, Spanien
        • Hosp Virgen Del Rocio

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

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are receiving a PI-containing highly active antiretroviral therapy (HAART) for at least 12 weeks.
  • Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4 weeks prior to randomization.
  • Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4 weeks before randomization.
  • Are at least 16 years old.
  • Have a documented virologic response to at least 1 HAART regimen.
  • Have phenotypic sensitivity to at least 2 of the following: ddl, d4T, ZDV, 3TC, ABC.
  • Have phenotypic sensitivity to atazanavir and LPV/RTV.
  • Use effective barrier methods of birth control.
  • Will be available for 48 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken 2 or more PIs and had virologic failure.
  • Have taken atazanavir or LPV/RTV.
  • Have an HIV-related infection (within 30 days) or any medical condition requiring treatment at the time of enrollment.
  • Have had acute hepatitis in the 30 days prior to study entry.
  • Have received certain drugs within 3 months of study start or expect to need them at time of enrollment.
  • Abuse alcohol or drugs in a way that would interfere with the study.
  • Have very bad diarrhea within 30 days prior to study entry.
  • Are pregnant or breast-feeding.
  • Have a history of hemophilia.
  • Use lipid-lowering drugs (within the previous 30 days).
  • Have cardiomyopathy or symptoms of other heart disease.
  • Cannot take medicine by mouth.
  • Have any other condition that would interfere with the study.
  • Have pancreatitis, if choosing ddI as part of NRTI pair.
  • Have bilateral peripheral neuropathy at time of screening, if choosing ddI or or d4T as part of the NRTI pair.

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: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

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.

Studer store datoer

Studiestart

1. februar 2001

Primær færdiggørelse (Faktiske)

1. september 2003

Studieafslutning (Faktiske)

1. september 2003

Datoer for studieregistrering

Først indsendt

20. december 2001

Først indsendt, der opfyldte QC-kriterier

20. december 2001

Først opslået (Skøn)

21. december 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. september 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2010

Sidst verificeret

1. september 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 302D
  • AI424-043

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 Atazanavir

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Myanmar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner