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Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs

23. juni 2005 opdateret af: Glaxo Wellcome

A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects

The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.

Studieoversigt

Status

Ukendt

Betingelser

HIV-infektioner

Intervention / Behandling

Detaljeret beskrivelse

Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.

Undersøgelsestype

Interventionel

Tilmelding

624

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
- California
  - Fountain Valley, California, Forenede Stater, 92708
    - Orange County Ctr for Special Immunology
  - Los Angeles, California, Forenede Stater, 90027
    - Aids Healthcare Foundation
  - Los Angeles, California, Forenede Stater, 90028
    - LAGLC
  - Sacramento, California, Forenede Stater, 95825
    - Kaiser Hospital
  - San Diego, California, Forenede Stater, 92103
    - Park Ctr for Health / Keith Vrhel
  - West Hollywood, California, Forenede Stater, 90069
    - AIDS Research Alliance
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 200091104
    - Dupont Circle Physicians Group
- Florida
  - Altamonte Springs, Florida, Forenede Stater, 32701
    - Infectious Disease Consultants
  - Coral Gables, Florida, Forenede Stater, 33146
    - CRI of South Florida
  - Fort Lauderdale, Florida, Forenede Stater, 33316
    - Gary Richmond MD
  - Fort Lauderdale, Florida, Forenede Stater, 33308
    - Therafirst Med Ctr
  - Miami, Florida, Forenede Stater, 33142
    - Specialty Med Care Ctrs of South Florida Inc
  - Miami, Florida, Forenede Stater, 33136
    - Univ of Miami Dept of Medicine
  - Sarasota, Florida, Forenede Stater, 34239
    - Infectious Diseases Associates
  - St. Petersburg, Florida, Forenede Stater, 33710
    - Jeffrey Levenson
  - Tampa, Florida, Forenede Stater, 33614
    - Infectious Disease Research Inst
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30308
    - AIDS Research Consortium of Atlanta
  - Augusta, Georgia, Forenede Stater, 30912
    - Med College of Georgia
  - Conyers, Georgia, Forenede Stater, 30013
    - SMO USA
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Indiana Univ Med School
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02115
    - Brigham and Women's Hosp
  - New Bedford, Massachusetts, Forenede Stater, 02745
    - Hawthorne Med Associates / PAACA
- Minnesota
  - Minneapolis, Minnesota, Forenede Stater, 55404
    - Abbott-Northwestern Hosp / Clinic 42
- Missouri
  - St. Louis, Missouri, Forenede Stater, 63139
    - Southampton Healthcare Inc
- 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
  - Bronx, New York, Forenede Stater, 10468
    - Bronx Veterans Affairs Med Ctr
  - Buffalo, New York, Forenede Stater, 14215
    - SUNY / Erie County Med Ctr at Buffalo
  - Manhasset, New York, Forenede Stater, 11030
    - North Shore Univ Hosp
  - New York, New York, Forenede Stater, 10019
    - St Lukes - Roosevelt Hosp Ctr
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 452670405
    - Univ of Cincinnati / Holmes Hosp
- Pennsylvania
  - Hershey, Pennsylvania, Forenede Stater, 170330850
    - Milton S Hershey Med Ctr
  - Philadelphia, Pennsylvania, Forenede Stater, 19102
    - Hahnemann Univ Hosp
- South Carolina
  - Columbia, South Carolina, Forenede Stater, 29206
    - Burnside Clinic
- Tennessee
  - Memphis, Tennessee, Forenede Stater, 38104
    - Methodist Healthcare
- Texas
  - Dallas, Texas, Forenede Stater, 75246
    - Nicholas Bellos
  - Houston, Texas, Forenede Stater, 77004
    - Joseph C Gathe

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:

Are at least 13 years old (consent of parent or guardian needed if under 18).
Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.

Exclusion Criteria

Patients will not be eligible for this study if they:

Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
Have an active/acute CDC Category C event.
Are unable to absorb or take medicines by mouth.
Are pregnant or breast-feeding.
Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
Have had pancreatitis or hepatitis within the last 6 months.
Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
Have received an HIV vaccine within 3 months before the study drug will be taken.
Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
Have received experimental treatments.
Have allergies which might interfere with the study, in the opinion of the doctor.

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

Glaxo Wellcome

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. november 2000

Datoer for studieregistrering

Først indsendt

23. januar 2001

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. marts 2002

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

316B
APV30002

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