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

This study is no longer recruiting patients.

Sponsored by: GlaxoSmithKline
Information provided by: AIDS Clinical Trials Information Service

Purpose

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).

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Abacavir sulfate, Lamivudine and Zidovudine
 Drug: Efavirenz
Phase IV

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Safety Study

Official Title: 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

Further Study Details: 

Expected Total Enrollment:  400

Study start: February 2001

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.

Eligibility

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information


Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85006,  United States

Arkansas
      Health for Life Clinic, Little Rock,  Arkansas,  72205,  United States

California
      Pacific Horizons Med Group, San Francisco,  California,  94115,  United States

      Orange County Ctr for Special Immunology, Fountain Valley,  California,  92708,  United States

Colorado
      Beacon Clinic / Boulder Community Hosp, Boulder,  Colorado,  80304,  United States

District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States

      Dupont Circle Physicians Group, Washington,  District of Columbia,  200091104,  United States

Florida
      Infectious Disease Consultants, Altamonte Springs,  Florida,  32701,  United States

      Univ of Miami / Jackson Memorial Hosp, Miami,  Florida,  33136,  United States

      North Broward Hosp District / HIV Clinical Research, Fort Lauderdale,  Florida,  33311,  United States

      SBMA Research, Miami Beach,  Florida,  33140,  United States

Georgia
      Infectious Disease Specialists of Atlanta, Decatur,  Georgia,  30033,  United States

Illinois
      Cook County Gen Hosp / Division of Infect Diseases, Chicago,  Illinois,  60612,  United States

      Northstar Med Clinic, Chicago,  Illinois,  60657,  United States

Kentucky
      University of Louisville / ID Division, Louisville,  Kentucky,  40202,  United States

Louisiana
      HIV Outpatient Clinics / LA State Univ Med Ctr, New Orleans,  Louisiana,  70112,  United States

Massachusetts
      Boston Med Ctr, Boston,  Massachusetts,  02118,  United States

Michigan
      Dr Paul Benson, Berkley,  Michigan,  48072,  United States

Minnesota
      Hennepin County Med Ctr, Minneapolis,  Minnesota,  55415,  United States

      Regions Hosp / HIV/AIDS Program, St. Paul,  Minnesota,  55101,  United States

Mississippi
      CRC of Mississippi, Jackson,  Mississippi,  39202,  United States

Nevada
      Wellness Ctr / Las Vegas, Las Vegas,  Nevada,  89102,  United States

New Jersey
      NJCRI, Newark,  New Jersey,  07103,  United States

      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States

New York
      SUNY / Health Sciences Ctr at Brooklyn, Brooklyn,  New York,  11203,  United States

      Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ, New York,  New York,  10021,  United States

North Carolina
      East Carolina Univ School of Medicine, Greenville,  North Carolina,  27858,  United States

      ID Consultants, Charlotte,  North Carolina,  28203,  United States

Ohio
      Summa Health System, Akron,  Ohio,  44304,  United States

Oklahoma
      Associates in Med and Mental Health, Tulsa,  Oklahoma,  74114,  United States

      Univ of Oklahoma Infectious Disease Institute, Oklahoma City,  Oklahoma,  73117,  United States

Tennessee
      Univ of Tennessee Med Ctr at Knoxville, Knoxville,  Tennessee,  37920,  United States

Texas
      Texas Tech Health Sciences Ctr, El Paso,  Texas,  79905,  United States

      Infectious Diseases Associates of Houston, Houston,  Texas,  77030,  United States

      Diversified Med Practices, PA, Houston,  Texas,  77027,  United States

      Therapeutic Concepts, Houston,  Texas,  77004,  United States

      AIDS Outreach Center, Fort Worth,  Texas,  76104,  United States

      Tarrant County Infectious Diseases Associates, Fort Worth,  Texas,  76104,  United States

      Metroplex Infectious Disease, Fort Worth,  Texas,  76104,  United States

Virginia
      Infectious Disease Physicians Inc, Annandale,  Virginia,  22003,  United States

      Infectious Disease Consultants, Fairfax,  Virginia,  22030,  United States

Washington
      Swedish Med Ctr, Seattle,  Washington,  98122,  United States

More Information

Study ID Numbers:  308B; ESS40013
Record last reviewed:  March 2002
Last Updated:  October 13, 2004
Record first received:  March 2, 2001
ClinicalTrials.gov Identifier:  NCT00011895
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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