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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 opdateret af: 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).

Studieoversigt

Status

Ukendt

Betingelser

HIV-infektioner

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding

400

Fase

Fase 4

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

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.
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

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

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. februar 2001

Datoer for studieregistrering

Først indsendt

2. marts 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

308B
ESS40013

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