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Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure

23. juni 2005 opdateret af: GlaxoSmithKline

A Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure

The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.

Undersøgelsestype

Interventionel

Tilmelding

330

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Phoenix Body Positive
    • California
      • Long Beach, California, Forenede Stater, 90803
        • Ocean View Internal Medicine
      • Los Angeles, California, Forenede Stater, 90048
        • Tower ID Med Associates
      • Los Angeles, California, Forenede Stater, 90046
        • Bisher Akil
      • Newport Beach, California, Forenede Stater, 92663
        • Orange Coast Med Group
      • San Francisco, California, Forenede Stater, 94115
        • Pacific Horizons Med Group
    • Colorado
      • Denver, Colorado, Forenede Stater, 80220
        • Denver Inf Disease Consultants
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • Physicans Home Service
    • Florida
      • Altamonte Springs, Florida, Forenede Stater, 32701
        • IDC Research Initiative
      • Bradenton, Florida, Forenede Stater, 34205
        • Bach and Godofsky
      • Fort Lauderdale, Florida, Forenede Stater, 33306
        • Community Health care
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Therafirst Med Ctr
      • Fort Lauderdale, Florida, Forenede Stater, 33311
        • North Broward Hosp District / HIV Clinical Research
      • Orlando, Florida, Forenede Stater, 32801
        • Florida ID Group
      • Pensacola, Florida, Forenede Stater, 32503
        • Discovery Alliance Inc
      • Pensacola, Florida, Forenede Stater, 32514
        • West Florida Clinical Research Ctr
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Med College of Georgia
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Med College / Dept of Infectious Diseases
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 021182393
        • Boston Med Ctr / Evans - 556
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Abbott-Northwestern Hosp / Clinic 42
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63139
        • Southampton Healthcare Inc
    • New Jersey
      • Somers Point, New Jersey, Forenede Stater, 08244
        • South Jersey Infectious Diseases Inc
      • Somerville, New Jersey, Forenede Stater, 08876
        • ID Care Inc
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Garden State Infectious Diseases / E I P Kennedy Health Sys
    • New York
      • New York, New York, Forenede Stater, 10011
        • Gervais Frechette
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Akron, Ohio, Forenede Stater, 44304
        • Summa Health System
    • Oregon
      • Portland, Oregon, Forenede Stater, 97219
        • Fanno Creek Clinic
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02908
        • Roger Williams Med Ctr
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38104
        • Methodist Healthcare
    • Texas
      • Houston, Texas, Forenede Stater, 77004
        • Joseph Gathe
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth Univ

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

13 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:

  • Have a viral load of 1,000 or more copies/ml.
  • Have taken protease inhibitors (PIs).
  • Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs.
  • Are now taking antiretroviral therapy.
  • Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18.
  • Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken APV or LPV for more than 1 week.
  • Have taken tenofovir disoproxil fumarate (TDF) or adefovir.
  • Have taken more than 2 PIs.
  • Are unable to take 2 active RTIs, as specified by the study.
  • Have an active CDC Category C disease.
  • Have certain abnormal laboratory tests.
  • Are pregnant or breast-feeding.
  • Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient.
  • Have a history of significant kidney or bone disease.
  • Are not able to take drugs by mouth and cannot absorb them.
  • Have had pancreatitis or hepatitis within the previous 6 months.
  • Have a drug allergy or other allergy which might cause a problem during the study.
  • Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study.
  • Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug.
  • Have had any HIV vaccine within 3 months before taking the study drug.
  • Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study.
  • Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study.
  • Are not able to take the study drugs.
  • Have inadequate kidney function.

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
  • Interventionel model: Parallel tildeling

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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. maj 2001

Datoer for studieregistrering

Først indsendt

15. oktober 2001

Først indsendt, der opfyldte QC-kriterier

15. oktober 2001

Først opslået (Skøn)

16. oktober 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2005

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2005

Sidst verificeret

1. juni 2002

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 316C

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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