The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir  Drug: Ritonavir  Drug: GW433908	Phase III

Further Study Details: 

Expected Total Enrollment:  330

Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.

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:

• Have a viral load of 1,000 or more copies/ml.
• Have taken protease inhibitors (PIs).
• Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs.
• Are now taking antiretroviral therapy.
• Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18.
• Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have taken APV or LPV for more than 1 week.
• Have taken tenofovir disoproxil fumarate (TDF) or adefovir.
• Have taken more than 2 PIs.
• Are unable to take 2 active RTIs, as specified by the study.
• Have an active CDC Category C disease.
• Have certain abnormal laboratory tests.
• Are pregnant or breast-feeding.
• Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient.
• Have a history of significant kidney or bone disease.
• Are not able to take drugs by mouth and cannot absorb them.
• Have had pancreatitis or hepatitis within the previous 6 months.
• Have a drug allergy or other allergy which might cause a problem during the study.
• Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study.
• Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug.
• Have had any HIV vaccine within 3 months before taking the study drug.
• Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study.
• Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study.
• Are not able to take the study drugs.
• Have inadequate kidney function.

Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85006,  United States
California
      Pacific Horizons Med Group, San Francisco,  California,  94115,  United States
      Tower ID Med Associates, Los Angeles,  California,  90048,  United States
      Ocean View Internal Medicine, Long Beach,  California,  90803,  United States
      Orange Coast Med Group, Newport Beach,  California,  92663,  United States
      Bisher Akil, Los Angeles,  California,  90046,  United States
Colorado
      Denver Inf Disease Consultants, Denver,  Colorado,  80220,  United States
District of Columbia
      Physicans Home Service, Washington,  District of Columbia,  20037,  United States
Florida
      Therafirst Med Ctr, Fort Lauderdale,  Florida,  33308,  United States
      Bach and Godofsky, Bradenton,  Florida,  34205,  United States
      Community Health Care, Fort Lauderdale,  Florida,  33306,  United States
      North Broward Hosp District / HIV Clinical Research, Fort Lauderdale,  Florida,  33311,  United States
      IDC Research Initiative, Altamonte Springs,  Florida,  32701,  United States
      Florida ID Group, Orlando,  Florida,  32801,  United States
      West Florida Clinical Research Ctr, Pensacola,  Florida,  32514,  United States
      Discovery Alliance Inc, Pensacola,  Florida,  32503,  United States
Georgia
      Med College of Georgia, Augusta,  Georgia,  30912,  United States
Illinois
      Rush Med College / Dept of Infectious Diseases, Chicago,  Illinois,  60612,  United States
Massachusetts
      Boston Med Ctr / Evans - 556, Boston,  Massachusetts,  021182393,  United States
Minnesota
      Abbott-Northwestern Hosp / Clinic 42, Minneapolis,  Minnesota,  55404,  United States
Missouri
      Southampton Healthcare Inc, St. Louis,  Missouri,  63139,  United States
New Jersey
      ID Care Inc, Somerville,  New Jersey,  08876,  United States
      Garden State Infectious Diseases / E I P Kennedy Health Sys, Voorhees,  New Jersey,  08043,  United States
      South Jersey Infectious Diseases Inc, Somers Point,  New Jersey,  08244,  United States
New York
      Gervais Frechette, New York,  New York,  10011,  United States
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
Ohio
      Summa Health System, Akron,  Ohio,  44304,  United States
Oregon
      Fanno Creek Clinic, Portland,  Oregon,  97219,  United States
Rhode Island
      Roger Williams Med Ctr, Providence,  Rhode Island,  02908,  United States
Tennessee
      Methodist Healthcare, Memphis,  Tennessee,  38104,  United States
Texas
      Joseph Gathe, Houston,  Texas,  77004,  United States
Virginia
      Virginia Commonwealth Univ, Richmond,  Virginia,  23298,  United States

Study ID Numbers:  316C
Record last reviewed:  June 2002
Last Updated:  October 13, 2004
Record first received:  October 15, 2001
ClinicalTrials.gov Identifier:  NCT00025727
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08