This randomized, multicenter study will compare the safety and efficacy of Lexiva plus ritonavir versus Kaletra (Lopinavir/ritonavir) over 48 weeks in ART (anti-retroviral therapy)-naive HIV-1 infected subjects while utilizing the Abacavir/lamivudine (ABC/3TC) FDC (fixed-dose combination tablet) as a NRTI (nucleoside reverse transcriptase inhibitor) backbone. This clinical research study evaluates the safety and efficacy (how well it works) of marketed HIV drugs [PI (protease inhibitor) plus NRTIs] given to HIV-infected patients who have not received prior therapy. All subjects will be screened and monitored at 12 scheduled clinic visits over a 48-week period. Abnormal laboratory values or certain side effects may require additional clinic visits over the course of the study.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Lexiva (GW433908)  Drug: Ritonavir  Drug: Kaletra  Drug: Epivir  Drug: Ziagen	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Persons with HIV-1 infections who have not started any antiretroviral medication regimen
• HIV-1 RNA (viral load) >1,000 c/mL
• Participants must be able to provide informed consent
• Have not received more than 14 days of prior treatment with HIV drugs
• Meet laboratory test criteria
• Women must abstain from sexual intercourse or use acceptable contraception
• Must be able to take study medications as directed and complete all study visits and evaluations during the 48-week study

Exclusion Criteria:

• Enrolled in other HIV treatment studies
• Pregnant or breastfeeding

Other protocol inclusion or exclusion criteria to be evaluated by the research physicians.

Alabama
      Birmingham,  Alabama,  35233,  United States
Arizona
      Phoenix,  Arizona,  85006,  United States
California
      Beverly Hills,  California,  90211,  United States
      San Diego,  California,  92106,  United States
      Newport Beach,  California,  92663,  United States
      San Francisco,  California,  94115,  United States
      Berkley,  California,  94705,  United States
      Sacramento,  California,  95825,  United States
Colorado
      Denver,  Colorado,  80220,  United States
District of Columbia
      Washington,  District of Columbia,  20036,  United States
      Washington,  District of Columbia,  20037,  United States
      Washington,  District of Columbia,  20057,  United States
Florida
      Altamonte Springs,  Florida,  32701,  United States
      Pembroke Pines,  Florida,  33024,  United States
      Miami,  Florida,  33101,  United States
      Fort Lauderdale,  Florida,  33308,  United States
      Tampa,  Florida,  33602,  United States
      Tampa,  Florida,  33607,  United States
      Tampa,  Florida,  33614,  United States
      Bradenton,  Florida,  34205,  United States
Georgia
      Atlanta,  Georgia,  30308,  United States
      Atlanta,  Georgia,  30339,  United States
Illinois
      Maywood,  Illinois,  60153,  United States
      Chicago,  Illinois,  60612,  United States
      Chicago,  Illinois,  60612,  United States
      Chicago,  Illinois,  60613,  United States
      Chicago,  Illinois,  60657,  United States
Indiana
      Indianapolis,  Indiana,  46202,  United States
      Indianapolis,  Indiana,  46202,  United States
Kentucky
      Lexington,  Kentucky,  40536,  United States
Maine
      Portland,  Maine,  04102,  United States
Maryland
      Baltimore,  Maryland,  21201,  United States
Massachusetts
      Boston,  Massachusetts,  02115,  United States
      Boston,  Massachusetts,  02118,  United States
Minnesota
      Minneapolis,  Minnesota,  55404,  United States
Mississippi
      Jackson,  Mississippi,  39202,  United States
Missouri
      St. Louis,  Missouri,  63108,  United States
New Jersey
      Newark,  New Jersey,  07103,  United States
      Voorhees,  New Jersey,  08043,  United States
      Somers Point,  New Jersey,  08244,  United States
      Hillsborough,  New Jersey,  08844,  United States
New York
      New York,  New York,  10014,  United States
      Bronx,  New York,  10461,  United States
      Bronx,  New York,  10468,  United States
      Stony Brook,  New York,  11794,  United States
      Rochester,  New York,  14604,  United States
North Carolina
      Chapel Hill,  North Carolina,  27516,  United States
      Durham,  North Carolina,  27710,  United States
      Greenville,  North Carolina,  27858,  United States
      Charlotte,  North Carolina,  28209,  United States
Ohio
      Toledo,  Ohio,  43614,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  19102,  United States
      Philadelphia,  Pennsylvania,  19107,  United States
Rhode Island
      Providence,  Rhode Island,  02906,  United States
South Carolina
      Columbia,  South Carolina,  29206,  United States
Tennessee
      Knoxville,  Tennessee,  37920,  United States
      Memphis,  Tennessee,  38163,  United States
Texas
      Dallas,  Texas,  75208,  United States
      Dallas,  Texas,  75246,  United States
      Dallas,  Texas,  75246,  United States
      Fort Worth,  Texas,  76104,  United States
      Houston,  Texas,  77004,  United States
      Houston,  Texas,  77030,  United States
Virginia
      Charlottesville,  Virginia,  22908,  United States
      Hampton,  Virginia,  23666,  United States
      Lynchburg,  Virginia,  24501,  United States
Washington
      Seattle,  Washington,  98111,  United States
      Seattle,  Washington,  98122,  United States
      Spokane,  Washington,  99204,  United States
Wisconsin
      Milwaukee,  Wisconsin,  53226,  United States
Austria
      Vienna,  A-1090,  Austria
      Vienna,  A-1090,  Austria
      Vienna,  A-1140,  Austria
Belgium
      Luxembourg,  1210,  Belgium
      Leuven,  3000,  Belgium
      LIEGE,  4000,  Belgium
      Charleroi,  6000,  Belgium
      Gent,  9000,  Belgium
Canada, Alberta
      Calgary,  Alberta,  T2P 1H9,  Canada
Canada, Ontario
      Ottawa,  Ontario,  K1N 6N5,  Canada
      Toronto,  Ontario,  M4N 3M5,  Canada
      Toronto,  Ontario,  M4T 3A7,  Canada
      Toronto,  Ontario,  M5B 1W8,  Canada
      Toronto,  Ontario,  M5G 2N2,  Canada
Canada, Quebec
      Montreal,  Quebec,  H2L 4P9,  Canada
      Montreal,  Quebec,  H2L 5B1,  Canada
      Montreal,  Quebec,  H2L 5B1,  Canada
France
      Bordeaux Cedex,  33076,  France
      Lyon cedex 02,  69288,  France
      Lyon Cedex 03,  69437,  France
      Paris,  75010,  France
      Paris,  75018,  France
      Paris Cedex 10,  75475,  France
      Paris Cedex13,  75651,  France
      Paris Cedex 14,  75679,  France
      Paris Cedex 20,  75970,  France
      Le Kremlin Bicetre Cedex,  94275,  France
Germany
      Berlin,  13353,  Germany
      Hamburg,  20095,  Germany
      Hamburg,  20099,  Germany
Germany, Bayern
      Muenchen,  Bayern,  80331,  Germany
      Fuerth,  Bayern,  90762,  Germany
Germany, Hessen
      Frankfurt,  Hessen,  60590,  Germany
Germany, Niedersachsen
      Hannover,  Niedersachsen,  30159,  Germany
Germany, Nordrhein-Westfalen
      Dortmund,  Nordrhein-Westfalen,  44137,  Germany
Italy
      Milano,  20157,  Italy
      Milano,  20157,  Italy
      Busto Arsizio,  21052,  Italy
Latvia
      Riga,  LV1006,  Latvia
Poland
      Warszawa,  01 201,  Poland
Portugal
      Lisboa,  1069-166,  Portugal
      Lisboa,  1150,  Portugal
      Lisboa,  1649-035,  Portugal
      Cascais,  2750,  Portugal
Switzerland
      Munchenstein,  4142,  Switzerland
      Lugano,  6900,  Switzerland
      St. Gallen,  9007,  Switzerland
      Zurich,  CH-8091,  Switzerland

Study ID Numbers:  100732
Record last reviewed:  January 2005
Last Updated:  January 18, 2005
Record first received:  June 17, 2004
ClinicalTrials.gov Identifier:  NCT00085943
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08