The purpose of this study is to test the short-term safety of a new once-daily fixed-dose combination tablet containing two drugs for treatment of HIV.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Investigational HIV drug	Phase III

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

Criteria

Inclusion Criteria:

• HIV-1 infection
• Subjects have not ever received any prior HIV treatment for more than 14 days
• Have a viral load of at least 1,000 copies/mL.

Exclusion Criteria:

• Enrollment in other investigational drug studies
• Women who are pregnant or breastfeeding
• History of allergy or hypersensitivity to abacavir or lamivudine
• Certain medical conditions evaluated by your doctor may make you ineligible

Alabama
      Momtgomery,  Alabama,  36105,  United States
Arizona
      Phoenix,  Arizona,  85015,  United States
      Glendale,  Arizona,  85306,  United States
      Tucson,  Arizona,  85745,  United States
Arkansas
      Little Rock,  Arkansas,  72207,  United States
California
      Los Angeles,  California,  90022,  United States
      Los Angeles,  California,  90027,  United States
      Los Angeles,  California,  90027,  United States
      Los Angeles,  California,  90028,  United States
      Los Angeles,  California,  90048,  United States
      Beverly Hills,  California,  90210,  United States
      Beverly Hills,  California,  90211,  United States
      Long Beach,  California,  90806,  United States
      Long Beach,  California,  90806,  United States
      Long Beach,  California,  90813,  United States
      Arleta,  California,  91331,  United States
      Tarzana,  California,  91356,  United States
      Tarzana,  California,  91356,  United States
      Pomona,  California,  91768,  United States
      Palm Springs,  California,  92262,  United States
      Palm Springs,  California,  92262,  United States
      Riverside,  California,  92507,  United States
      Newport Beach,  California,  92663,  United States
      Salinas,  California,  93912,  United States
      San Francisco,  California,  94114,  United States
      San Francisco,  California,  94114,  United States
      San Francisco,  California,  94114,  United States
      San Francisco,  California,  94114,  United States
      Oakland,  California,  94602,  United States
      Millvalley,  California,  94941,  United States
      Santa Rosa,  California,  95404,  United States
Colorado
      Denver,  Colorado,  80206,  United States
Connecticut
      Glastonbury,  Connecticut,  06033,  United States
      New Haven,  Connecticut,  06520,  United States
      Stratford,  Connecticut,  06614,  United States
      Norwalk,  Connecticut,  06851,  United States
District of Columbia
      Washington,  District of Columbia,  20037,  United States
Florida
      Daytona Beach,  Florida,  32117,  United States
      Tallahassee,  Florida,  32308,  United States
      Gainesville,  Florida,  32601,  United States
      Altamonte Springs,  Florida,  32701,  United States
      Orlando,  Florida,  32806,  United States
      Orlando,  Florida,  32806,  United States
      Orlando,  Florida,  32806,  United States
      Melbourne,  Florida,  32935,  United States
      Key West,  Florida,  33040,  United States
      Pompano Beach,  Florida,  33062,  United States
      Pompano Beach,  Florida,  33062,  United States
      Coral Springs,  Florida,  33065,  United States
      Coral Gables,  Florida,  33134,  United States
      Miami Beach,  Florida,  33139,  United States
      Miami Beach,  Florida,  33139,  United States
      Miami Beach,  Florida,  33139,  United States
      South Miami,  Florida,  33143,  United States
      Ft. Lauderdale,  Florida,  33145,  United States
      North Miami,  Florida,  33161,  United States
      Miami,  Florida,  33176,  United States
      Ft. Lauderdale,  Florida,  33316,  United States
      Plantation,  Florida,  33317,  United States
      Oakland Park,  Florida,  33334,  United States
      West Palm Beach,  Florida,  33401,  United States
      North Palm Beach,  Florida,  33408,  United States
      Tampa,  Florida,  33614,  United States
      Tampa,  Florida,  33614,  United States
      Tampa,  Florida,  33614,  United States
      St. Petersburg,  Florida,  33710,  United States
      Ft. Myers,  Florida,  33901,  United States
      Ft. Myers,  Florida,  33901,  United States
      Inmokalee,  Florida,  34142,  United States
      Sarasota,  Florida,  34239,  United States
      Safety Harbor,  Florida,  34695,  United States
Georgia
      Lawrenceville,  Georgia,  30045,  United States
      Austell,  Georgia,  30106,  United States
      Riverdale,  Georgia,  30274,  United States
      Atlanta,  Georgia,  30309,  United States
      Atlanta,  Georgia,  30309,  United States
      Atlanta,  Georgia,  30312,  United States
      Atlanta,  Georgia,  30312,  United States
      Atlanta,  Georgia,  30318,  United States
      Atlanta,  Georgia,  30329,  United States
      Atlanta,  Georgia,  30342,  United States
      Atlanta,  Georgia,  30342,  United States
      Columbus,  Georgia,  31906,  United States
Idaho
      Boise,  Idaho,  83704,  United States
Illinois
      Elgin,  Illinois,  60120,  United States
      Joilet,  Illinois,  60432,  United States
      East St. Louis,  Illinois,  62207,  United States
Indiana
      Indianapolis,  Indiana,  46204,  United States
Iowa
      Des Moines,  Iowa,  50309,  United States
Kentucky
      Louisville,  Kentucky,  40202,  United States
      Henderson,  Kentucky,  42420,  United States
Louisiana
      New Orleans,  Louisiana,  70115,  United States
      New Orleans,  Louisiana,  70117,  United States
      Baton Rouge,  Louisiana,  70816,  United States
Maryland
      Bethesda,  Maryland,  20816,  United States
      Silver Spring,  Maryland,  20910,  United States
      Baltimore,  Maryland,  21209,  United States
      Baltimore,  Maryland,  21218,  United States
Massachusetts
      Springfield,  Massachusetts,  01107,  United States
      Lowell,  Massachusetts,  01854,  United States
      Boston,  Massachusetts,  02215,  United States
Michigan
      Berkley,  Michigan,  48072,  United States
Missouri
      Chesterfield,  Missouri,  63017,  United States
      St. Louis,  Missouri,  63117,  United States
      Kansas City,  Missouri,  64110,  United States
      Kansas City,  Missouri,  64112,  United States
Nevada
      Las Vegas,  Nevada,  89102,  United States
New Jersey
      East Orange,  New Jersey,  07017,  United States
      East Orange,  New Jersey,  07018,  United States
      Westfield,  New Jersey,  07090,  United States
      Newark,  New Jersey,  07102,  United States
      Jersey City,  New Jersey,  07304,  United States
      Berkley,  New Jersey,  07306,  United States
      Englewood,  New Jersey,  07631,  United States
      Galloway,  New Jersey,  08205,  United States
      Somers Point,  New Jersey,  08244,  United States
      Clinton,  New Jersey,  20735,  United States
New Mexico
      Santa Fe,  New Mexico,  87505,  United States
New York
      New York,  New York,  10003,  United States
      New York,  New York,  10003,  United States
      New York,  New York,  10003,  United States
      New York,  New York,  10003,  United States
      New York,  New York,  10011,  United States
      New York,  New York,  10016,  United States
      New York,  New York,  10019,  United States
      New York,  New York,  10019,  United States
      New York,  New York,  10019,  United States
      New York,  New York,  10022,  United States
      Staten Island,  New York,  10304,  United States
      Scarsdale,  New York,  10583,  United States
      Manhasset,  New York,  11030,  United States
      Brooklyn,  New York,  11215,  United States
      Brooklyn,  New York,  11237,  United States
      Albany,  New York,  12208,  United States
North Carolina
      Winston Salem,  North Carolina,  27103,  United States
      Huntersville,  North Carolina,  28078,  United States
      Charlotte,  North Carolina,  28211,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  19103,  United States
      Philadelphia,  Pennsylvania,  19107,  United States
      Philadelphia,  Pennsylvania,  19143,  United States
South Carolina
      Spartanburg,  South Carolina,  29303,  United States
Tennessee
      Johnson City,  Tennessee,  37614,  United States
      Memphis,  Tennessee,  38102,  United States
      Memphis,  Tennessee,  38104,  United States
Texas
      Dallas,  Texas,  75205,  United States
      Dallas,  Texas,  75219,  United States
      Long View,  Texas,  75604,  United States
      Tyler,  Texas,  75708,  United States
      Fort Worth,  Texas,  76104,  United States
      Houston,  Texas,  77004,  United States
      Houston,  Texas,  77098,  United States
      Houston,  Texas,  77098,  United States
      Houston,  Texas,  77098,  United States
Virginia
      Annandale,  Virginia,  22003,  United States
      Richmond,  Virginia,  23224,  United States
Washington
      Spokane,  Washington,  99204,  United States
Wisconsin
      Milwaukee,  Wisconsin,  53212,  United States

Study ID Numbers:  101822
Record last reviewed:  October 2004
Record first received:  October 16, 2004
ClinicalTrials.gov Identifier:  NCT00094367
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10