With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Lopinavir/ritonavir  Drug: Efavirenz  Drug: Stavudine  Drug: Zidovudine  Drug: Lamivudine  Drug: Tenofovir disoproxil fumarate	Phase III

Further Study Details: 

Expected Total Enrollment:  775

Numerous treatment options are available to HIV infected patients who are antiretroviral (ARV) therapy naive, but an optimal regimen has not yet been established. This study will compare a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, a ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen, and a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen for the initial treatment of HIV infection.

Patients will be randomly assigned to one of three study arms. In Arm A, patients will receive lopinavir/ritonavir (LPV/r) twice daily and efavirenz (EFV) once daily before bed. Arm B patients will receive LPV/r twice daily, lamivudine (3TC) once daily, plus either stavudine extended release (d4T XR) once daily, zidovudine (ZDV) twice daily, or tenofovir disoproxil fumarate (TDF) once daily. Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed, ZDV twice daily, or TDF once daily before bed.

Study visits will occur every 4 weeks until Week 24, then every 8 weeks thereafter for a maximum of 96 weeks. Blood will be drawn at every visit and a urine sample will be collected every 8 weeks. Body measurements will be taken at Weeks 24, 48, 72, and 96. Whole body dual-energy x-ray absorptiometry (DEXA) scans will be done at Weeks 48 and 96. Patients must fast before study visits at Weeks 12, 24, 48, 72, and 96. Women in the study will have gynecological assessments every 24 weeks.

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

Criteria

Inclusion Criteria for Step 1:

• HIV infected
• HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry
• Willing to use acceptable means of contraception
• d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm
• Coenrolled in ACTG A5152s

Exclusion Criteria for Step 1:

• On ARV therapy for 7 days or more any time prior to study entry
• NNRTIs or 3TC at any time prior to study entry
• Current peripheral neuropathy of Grade 2 or higher
• Pregnancy or breastfeeding
• Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded.
• Human growth hormone within 30 days prior to study entry
• Initiation of testosterone or anabolic steroids within 30 days prior to study entry
• Certain other medications within 30 days of study entry
• Hypersensitivity to components of the study drug formulations
• Drug or alcohol use or dependence that would interfere with adherence to study requirements
• Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry
• Recent infection with drug-resistant HIV

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35924,  United States
California
      Stanford Univ, Stanford,  California,  94305-5107,  United States
      San Mateo County AIDS Program, Stanford,  California,  94305-5107,  United States
      Willow Clinic, Stanford,  California,  94305-5107,  United States
      Univ of California, Davis Med Ctr, Sacramento,  California,  95814,  United States
      Univ of California, San Diego Antiviral Research Ctr, San Diego,  California,  92103,  United States
      San Francisco Gen Hosp, San Francisco,  California,  94110,  United States
      Santa Clara Valley Med Ctr, Stanford,  California,  94305-5107,  United States
      UCLA School of Medicine, Los Angeles,  California,  90095-1793,  United States
      Univ of Southern California, Los Angeles,  California,  90033-1079,  United States
      Harbor General/UCLA, Torrance,  California,  90502-2052,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver, Denver,  Colorado,  80262-3706,  United States
District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
Florida
      Univ of Miami, Miami,  Florida,  33136,  United States
Georgia
      Emory Univ, Atlanta,  Georgia,  30308,  United States
Hawaii
      Univ of Hawaii, Honolulu,  Hawaii,  96816,  United States
Illinois
      Rush-Presbyterian /St. Lukes (Chicago), Chicago,  Illinois,  60612-3806,  United States
      Northwestern Univ, Chicago,  Illinois,  60611-3015,  United States
      Cook County Hosp Core Ctr, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  46202-5250,  United States
      Methodist Hosp of Indiana, Indianapolis,  Indiana,  46202-1261,  United States
      Wishard Hosp, Indianapolis,  Indiana,  46202,  United States
Iowa
      University of Iowa Hospital and Clinics, Iowa City,  Iowa,  52242-1201,  United States
Maryland
      Univ of Maryland, Institute of Human Virology, Baltimore,  Maryland,  21201,  United States
      Johns Hopkins Univ, Baltimore,  Maryland,  21287,  United States
Massachusetts
      Beth Israel Deaconess, Boston,  Massachusetts,  02215,  United States
      Harvard (Massachusetts General Hosp), Boston,  Massachusetts,  02114,  United States
      Brigham and Womens Hosp, Boston,  Massachusetts,  02215,  United States
      Boston Med Ctr (Harvard), Boston,  Massachusetts,  02118,  United States
Minnesota
      Univ of Minnesota, Minneapolis,  Minnesota,  55455-0392,  United States
Missouri
      Washington Univ (St. Louis), St. Louis,  Missouri,  63108-2138,  United States
      St. Louis Connect Care, St. Louis,  Missouri,  63108-2138,  United States
Nebraska
      Nebraska Health System, Omaha,  Nebraska,  68198-5130,  United States
New York
      Univ of Rochester Med Ctr, Rochester,  New York,  14642-0001,  United States
      Community Health Network, Inc., Rochester,  New York,  14642-0001,  United States
      St. Mary's Hospital, Rochester,  New York,  14642-0001,  United States
      SUNY-Buffalo (Rochester), Buffalo,  New York,  14215,  United States
      The Cornell Clinical Trials Unit, New York,  New York,  10021,  United States
      Chelsea Clinic, New York,  New York,  10011,  United States
      NYU/Bellevue, New York,  New York,  10016-6481,  United States
      Columbia Univ, New York,  New York,  10032-3784,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
      Univ of North Carolina, Chapel Hill,  North Carolina,  27514,  United States
      Wake County Department of Health, Chapel Hill,  North Carolina,  27514,  United States
Ohio
      MetroHealth Med Ctr, Cleveland,  Ohio,  44109-1998,  United States
      Univ of Cincinnati, Cincinnati,  Ohio,  45267-0405,  United States
      Ohio State Univ, Columbus,  Ohio,  43210-1282,  United States
      Case Western Reserve Univ, Cleveland,  Ohio,  44106-5083,  United States
      Cleveland Clinic, Cleveland,  Ohio,  44109-5083,  United States
Pennsylvania
      Univ of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2582,  United States
      Univ of Pennsylvania, Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Presbyterian Med Ctr, Norristown,  Pennsylvania,  19401,  United States
Rhode Island
      The Miriam Hosp, Providence,  Rhode Island,  02906,  United States
      Rhode Island Hosp, Providence,  Rhode Island,  02906,  United States
      Stanley Street Treatment and Resource, Providence,  Rhode Island,  02906,  United States
Tennessee
      Comprehensive Care Clinic, Nashville,  Tennessee,  37203,  United States
Texas
      Univ of Texas, Galveston, Galveston,  Texas,  77555-0435,  United States
      Univ of Texas, Southwestern Med Ctr, Dallas,  Texas,  75235-9173,  United States
Washington
      Univ of Washington (Seattle), Seattle,  Washington,  98104,  United States

Study chairs or principal investigators

Sharon Riddler, MD,  Study Chair,  University of Pittsburgh, Division of Infectious Diseases   
Richard Haubrich, MD,  Study Chair,  University of California, San Diego, Division of Infectious Diseases   

Study ID Numbers:  ACTG A5142; A5152s; A5160s
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  December 30, 2002
ClinicalTrials.gov Identifier:  NCT00050895
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08