Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

19. februar 2009 opdateret af: Abbott

A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients receive 1 of the following:

  1. ABT-378/RTV plus NVP plus 2 NRTIs; or
  2. Investigator-selected PI(s) plus NVP plus 2 NRTIs.

Undersøgelsestype

Interventionel

Tilmelding

300

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Herston, Australien
        • Royal Brisbane Hosp
  • Brasilien
      • Manguinhos RJ, Brasilien
        • Hosp Evandro Chagas Fioernz
      • Sao Paulo, Brasilien
        • Castelo
      • Sao Paulo, Brasilien
        • Fundacao Zerbini Casa Da Aids
      • Sao Paulo, Brasilien
        • Hosp Do Servidor Publico Estadual De Sao Paulo
      • Sao Paulo, Brasilien
        • Hosp Heliopolis
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Saint Paul's Hosp
    • Ontario
      • Ottawa, Ontario, Canada
        • Ottawa General Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Ctr
      • Toronto, Ontario, Canada
        • Toronto Gen Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique Medicale du Quartier Latin
      • Montreal, Quebec, Canada
        • Clinique Medicale L'Actuele
      • Montreal, Quebec, Canada
        • Montreal Chest Institute
  • Danmark
      • Copenhagen, Danmark
        • Righospitalet
      • Hvidovre, Danmark
        • Hvidovre Univ Hosp
      • Odense C, Danmark
        • Odense Univ Hosp
  • Det Forenede Kongerige
      • Brighton, Det Forenede Kongerige
        • Brighton Gen Hosp
      • London, Det Forenede Kongerige
        • Chelsea and Westminster Hosp
      • London, Det Forenede Kongerige
        • Royal Free Hosp
      • London, Det Forenede Kongerige
        • Imperial College School of Medicine
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Univ of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Phoenix Body Positive
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Pacific Oaks Med Group
      • Fountain Valley, California, Forenede Stater, 92708
        • Orange County Ctr for Special Immunology
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, Forenede Stater, 90048
        • Tower ID Med Associates
      • Los Angeles, California, Forenede Stater, 900276069
        • Aids Healthcare Foundation
      • San Francisco, California, Forenede Stater, 94121
        • San Francisco Veterans Administration Med Ctr
      • Torrance, California, Forenede Stater, 90502
        • Harbor - UCLA Med Ctr
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale Univ / AIDS Clinical Trials Unit
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • Univ of Miami School of Medicine
      • Tampa, Florida, Forenede Stater, 33614
        • Infectious Disease Research Institute
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • AIDS Research Consortium of Atlanta
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory Univ
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Cook County Hosp
      • Chicago, Illinois, Forenede Stater, 60657
        • AIDS Research Alliance - Chicago
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Division of Inf Diseases/ Indiana Univ Hosp
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Univ of Kansas School of Medicine
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Univ Med School
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston Med Ctr
      • Brookline, Massachusetts, Forenede Stater, 02445
        • Community Research Initiative of New England
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 481090378
        • Univ of Michigan Hospitals and Health Ctrs
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Abbott Northwestern Hosp
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07102
        • St Michaels Med Ctr
      • Newark, New Jersey, Forenede Stater, 07102
        • Saint Michael's Med Ctr / Dept of Infectious Diseases
    • New York
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Med Ctr
      • New York, New York, Forenede Stater, 10011
        • Cornell Clinical Trials Unit - Chelsea Clinic
      • New York, New York, Forenede Stater, 10011
        • Howard Grossman
      • Stony Brook, New York, Forenede Stater, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
      • Stony Brook, New York, Forenede Stater, 117948153
        • SUNY at Stony Brook / Div of Infectious Disease
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Univ Med Ctr / Infectious Disease Clinic
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 452670405
        • Holmes Hosp / Univ of Cincinnati Med Ctr
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74114
        • Associates in Med and Mental Health
    • Oregon
      • Portland, Oregon, Forenede Stater, 972109951
        • Oregon Health Sciences Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Philadelphia FIGHT
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Stephen Hauptman
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • The Miriam Hosp
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Univ of Texas Southwestern Med Ctr
      • Dallas, Texas, Forenede Stater, 75219
        • Oaklawn Physicians Group
      • Galveston, Texas, Forenede Stater, 775550835
        • Univ of Texas / Med Branch at Galveston
      • Houston, Texas, Forenede Stater, 77004
        • Joseph C Gathe
    • 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
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Univ of Virginia Health Sciences Ctr
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Univ of Wisconsin
  • Frankrig
      • Paris, Frankrig
        • CHU de Bicêtre
      • Paris Cedex 18, Frankrig
        • Groupe hospitalier Bichat-Claude Bernard
      • Tourcoing, Frankrig
        • Hôpital Gustave Dron
      • Villejuif, Frankrig
        • Hôpital Paul Brousse
  • Polen
      • Warszawa, Polen
        • Ctr of AIDS Diagnosis and Treatment
  • Puerto Rico
      • Ponce, Puerto Rico, 00731
        • Ponce Univ Hosp
  • Schweiz
      • Zurich, Schweiz
        • Universitätsspital Zürich
  • Spanien
      • Barcelona, Spanien
        • Hosp Germans Trias I Pujol
      • Madrid, Spanien
        • Hosp Carlos III
      • Madrid, Spanien
        • Hosp De Mostoles
      • Madrid, Spanien
        • Hosp Doce De Octubre
      • Madrid, Spanien
        • Hosp La Paz
      • Sevilla, Spanien
        • Hosp Virgen Del Rocio
  • Sydafrika
      • Belford Gardens, Sydafrika
        • Miller
      • Johannesburg, Sydafrika
        • Cyrildene
  • Tyskland
      • Berlin, Tyskland
        • EPIMED
      • Dusseldorf, Tyskland
        • Heinrich Heine Universitat
      • Frankfurt, Tyskland
        • Klinikum Der Johann Wolfgang Goethe Universitat
      • Hamburg, Tyskland
        • Allgemeines Krankenhaus St Georg
      • Koeln, Tyskland
        • Univ Zu Koeln
      • Mannheim, Tyskland
        • Aids Study Group Mannheim
  • Østrig
      • Wien, Østrig
        • Pulmologisches Zentrum Der Stadt Wien

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

12 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 at least 12 years old.
  • Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
  • Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
  • Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
  • Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have an active illness.
  • Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
  • Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
  • Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
  • Have received treatment with a PI other than their current PI.
  • Are receiving chemotherapy for cancer.
  • Are pregnant or breast-feeding.

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

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott

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)

20. februar 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2009

Sidst verificeret

1. februar 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 285D
  • M98-888

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 .

Abonner