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Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs

23. juni 2005 opdateret af: Glaxo Wellcome

A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection

The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.

Undersøgelsestype

Interventionel

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • Hosp Muniz
      • Rosario - Santa Fe, Argentina
        • CAICI
  • Brasilien
      • Campinas - SP, Brasilien
        • Universidade de Campinas
      • Manguinhos RJ, Brasilien
        • Hosp Evandro Chagas Fioernz
      • Rio de Janeiro - RJ, Brasilien
        • Hosp Univ Clementino Fraga Filho
      • Rio de Janeiro - RJ, Brasilien
        • Hosp Univ Pedro Ernesto / Univ Estadual do RJ
      • Sao Paulo - SP, Brasilien
        • Hosp Sao Paulo da Universidade Federal de Sao Paulo
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Southern Alberta HIV Clinic / Foothills Hosp
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Saint Paul's Hosp
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Centre
      • Toronto, Ontario, Canada
        • Toronto Gen Hosp
      • Toronto, Ontario, Canada
        • Wellesley/Central Site / St Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique Medicale du Quartier Latin
      • Montreal, Quebec, Canada
        • Clinique Medicale L'Actuele
      • Ste Foy, Quebec, Canada
        • Centre Hospitalier Universitaire de Quebec
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Phoenix Body Positive
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Pacific Oaks Research
      • Los Angeles, California, Forenede Stater, 90048
        • Tower ID Med Associates
      • Los Angeles, California, Forenede Stater, 900276069
        • AIDS Healthcare Foundation
      • San Francisco, California, Forenede Stater, 94118
        • Kaiser Foundation Hospital
      • San Francisco, California, Forenede Stater, 94114
        • Davies Med Ctr / c/o HIV Institute
      • Torrance, California, Forenede Stater, 90509
        • Harbor - UCLA Med Ctr
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, Forenede Stater, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Altamonte Springs, Florida, Forenede Stater, 32701
        • IDC Research Initiative
      • Bradenton, Florida, Forenede Stater, 34205
        • Bach and Godofsky
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • TheraFirst Med Ctrs Inc
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • North Broward Hosp District
      • Fort Lauderdale, Florida, Forenede Stater, 33334
        • The Coleman Institute Inc
      • Fort Pierce, Florida, Forenede Stater, 34950
        • The Coleman Institute Inc
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30339
        • Kaiser Permanente Infectious Diseases
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60657
        • AIDS Research Alliance - Chicago
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46218
        • Infectious Disease of Indiana
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Univ of Kentucky Med Ctr
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane Univ School of Medicine
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 021182393
        • Boston Med Ctr / Evans - 556
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64132
        • Antibiotic Research Associates
    • New Jersey
      • East Orange, New Jersey, Forenede Stater, 07018
        • East Orange Veterans Administration Med Ctr
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • ID Care Inc
      • Princeton, New Jersey, Forenede Stater, 08540
        • ID Care Inc
      • Randolph, New Jersey, Forenede Stater, 07869
        • ID Care Inc
      • Somerville, New Jersey, Forenede Stater, 08876
        • ID Care Inc
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Albany Med College / Div of HIV Medicine
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore Univ Hosp / Div of Infectious Diseases
      • New York, New York, Forenede Stater, 10011
        • St Vincents Hosp / Clinical Research Program
      • New York, New York, Forenede Stater, 10019
        • St Lukes / Roosevelt Hosp / HIV Center
    • Ohio
      • Columbus, Ohio, Forenede Stater, 432101228
        • Ohio State Univ Hosp Clinic
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74107
        • Oklahoma State University / College of Osteopathic Medicine
      • Tulsa, Oklahoma, Forenede Stater, 74114
        • Associates in Med and Mental Health
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Miriam Hosp / Brown Univ
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38104
        • Methodist Healthcare
      • Memphis, Tennessee, Forenede Stater, 38163
        • Univ of Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, Forenede Stater, 75219
        • Nelson-Tebedo Community Clinic
      • Dallas, Texas, Forenede Stater, 75219
        • Dr David Donnell
      • Galveston, Texas, Forenede Stater, 77555
        • Univ of Texas Med Branch
      • Houston, Texas, Forenede Stater, 77006
        • Montrose Clinic
      • Houston, Texas, Forenede Stater, 770303498
        • Baylor College of Medicine / Dept of Medicine
      • Houston, Texas, Forenede Stater, 77030
        • Univ of Texas / Med School at Houston
      • San Antonio, Texas, Forenede Stater, 782847838
        • Univ of Texas Health Sciences Ctr
    • Virginia
      • Hampton, Virginia, Forenede Stater, 23666
        • Hampton Roads Med Specialists
  • Puerto Rico
      • Caguas, Puerto Rico, 00726
        • Caguas Regional Hosp
      • Cotto Laurel, Puerto Rico, 00780
        • Hosp San Cristobal-Edif A
      • Guaynabo, Puerto Rico, 00966
        • Carlos Leon-Valiente MD
      • Mayaguez, Puerto Rico, 00680
        • Ramon Ramirez Ronda MD
      • Santurce, Puerto Rico, 00908
        • San Juan AIDS Program

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

18 år og ældre (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 18 years of age or older.
  • Are HIV-positive.
  • Have a viral load (level of HIV in the blood) of at least 400 copies/ml within 21 days of study entry.
  • Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry.
  • Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children).

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken any antiretroviral (anti-HIV) agent.
  • Are pregnant or breast-feeding.
  • Are unable to absorb food or have trouble taking medicines by mouth.
  • Abuse alcohol or drugs to an extent that may make study participation difficult.
  • Are not likely to be able to complete the 48 weeks of study treatment.
  • Have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease.
  • Have received an investigational vaccine within the past 3 months or have received gene therapy.
  • Have a severe medical condition such as diabetes or heart trouble.
  • Have been diagnosed with AIDS.
  • Have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of Kaposi's sarcoma.
  • Are taking medications that affect the immune system within 30 days of study entry.
  • Are taking medications that may interact with the study drugs.

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

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. september 1999

Datoer for studieregistrering

Først indsendt

2. marts 2000

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. august 2000

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 225D
  • EPV2000 1

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 Lamivudin

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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