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

Further Study Details: 

Expected Total Enrollment:  400

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.

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.

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

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