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Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

23. juni 2005 oppdatert av: GlaxoSmithKline

A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects

The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone.

An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.

Studietype

Intervensjonell

Registrering

400

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85006
        • Phoenix Body Positive
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205
        • Health for Life Clinic
    • California
      • Fountain Valley, California, Forente stater, 92708
        • Orange County Ctr for Special Immunology
      • San Francisco, California, Forente stater, 94115
        • Pacific Horizons Med Group
    • Colorado
      • Boulder, Colorado, Forente stater, 80304
        • Beacon Clinic / Boulder Community Hosp
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 200091104
        • Dupont Circle Physicians Group
      • Washington, District of Columbia, Forente stater, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Altamonte Springs, Florida, Forente stater, 32701
        • Infectious Disease Consultants
      • Fort Lauderdale, Florida, Forente stater, 33311
        • North Broward Hosp District / HIV Clinical Research
      • Miami, Florida, Forente stater, 33136
        • Univ of Miami / Jackson Memorial Hosp
      • Miami Beach, Florida, Forente stater, 33140
        • SBMA Research
    • Georgia
      • Decatur, Georgia, Forente stater, 30033
        • Infectious Disease Specialists of Atlanta
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Cook County Gen Hosp / Division of Infect Diseases
      • Chicago, Illinois, Forente stater, 60657
        • Northstar Med Clinic
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • University of Louisville / ID Division
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • HIV Outpatient Clinics / LA State Univ Med Ctr
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Boston Med Ctr
    • Michigan
      • Berkley, Michigan, Forente stater, 48072
        • Dr Paul Benson
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55415
        • Hennepin County Med Ctr
      • St. Paul, Minnesota, Forente stater, 55101
        • Regions Hosp / HIV/AIDS Program
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39202
        • CRC of Mississippi
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89102
        • Wellness Ctr / Las Vegas
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center
      • Newark, New Jersey, Forente stater, 07103
        • NJCRI
    • New York
      • Brooklyn, New York, Forente stater, 11203
        • SUNY / Health Sciences Ctr at Brooklyn
      • New York, New York, Forente stater, 10021
        • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28203
        • ID Consultants
      • Greenville, North Carolina, Forente stater, 27858
        • East Carolina Univ School of Medicine
    • Ohio
      • Akron, Ohio, Forente stater, 44304
        • Summa Health System
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73117
        • Univ of Oklahoma Infectious Disease Institute
      • Tulsa, Oklahoma, Forente stater, 74114
        • Associates in Med and Mental Health
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37920
        • Univ of Tennessee Med Ctr at Knoxville
    • Texas
      • El Paso, Texas, Forente stater, 79905
        • Texas Tech Health Sciences Ctr
      • Fort Worth, Texas, Forente stater, 76104
        • Tarrant County Infectious Diseases Associates
      • Fort Worth, Texas, Forente stater, 76104
        • AIDS Outreach Center
      • Fort Worth, Texas, Forente stater, 76104
        • Metroplex Infectious Disease
      • Houston, Texas, Forente stater, 77027
        • Diversified Med Practices, PA
      • Houston, Texas, Forente stater, 77004
        • Therapeutic Concepts
      • Houston, Texas, Forente stater, 77030
        • Infectious Diseases Associates of Houston
    • Virginia
      • Annandale, Virginia, Forente stater, 22003
        • Infectious Disease Physicians Inc
      • Fairfax, Virginia, Forente stater, 22030
        • Infectious Disease Consultants
    • Washington
      • Seattle, Washington, Forente stater, 98122
        • Swedish Med Ctr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 13 years old.
  • Are HIV-positive.
  • Have a viral load of at least 5,000 copies/ml.
  • Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate.
  • Provide written consent of a parent or guardian, if under 18 years of age.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken nonnucleoside reverse transcriptase inhibitors.
  • Have taken other anti-HIV drugs for 2 weeks or more.
  • Have an opportunistic (AIDS-related) infection.
  • Are pregnant or breast-feeding.
  • Have had hepatitis within the past 6 months.
  • Are allergic to the study drugs or their ingredients.
  • Have a mental, physical, or substance abuse disorder.
  • Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
  • Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth.
  • Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons).
  • Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period.
  • Require foscarnet or other drugs that are shown to be effective against HIV.
  • Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives.
  • Are taking experimental drugs.
  • Are unlikely to complete the study or take the drugs.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2001

Datoer for studieregistrering

Først innsendt

2. mars 2001

Først innsendt som oppfylte QC-kriteriene

30. august 2001

Først lagt ut (Anslag)

31. august 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. juni 2005

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2005

Sist bekreftet

1. mars 2002

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 308B
  • ESS40013

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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