The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Ritonavir  Drug: Abacavir sulfate  Drug: Nelfinavir mesylate  Drug: Lamivudine  Drug: GW433908	Phase III

Further Study Details: 

Expected Total Enrollment:  624

Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.

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 (consent of parent or guardian needed if under 18).
• Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
• Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
• Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
• Have an active/acute CDC Category C event.
• Are unable to absorb or take medicines by mouth.
• Are pregnant or breast-feeding.
• Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
• Have had pancreatitis or hepatitis within the last 6 months.
• Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
• Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
• Have received an HIV vaccine within 3 months before the study drug will be taken.
• Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
• Have received experimental treatments.
• Have allergies which might interfere with the study, in the opinion of the doctor.

California
      Park Ctr for Health / Keith Vrhel, San Diego,  California,  92103,  United States
      AIDS Healthcare Foundation, Los Angeles,  California,  90027,  United States
      AIDS Research Alliance, West Hollywood,  California,  90069,  United States
      Orange County Ctr for Special Immunology, Fountain Valley,  California,  92708,  United States
      LAGLC, Los Angeles,  California,  90028,  United States
      Kaiser Hospital, Sacramento,  California,  95825,  United States
District of Columbia
      Dupont Circle Physicians Group, Washington,  District of Columbia,  200091104,  United States
Florida
      Univ of Miami Dept of Medicine, Miami,  Florida,  33136,  United States
      Infectious Disease Consultants, Altamonte Springs,  Florida,  32701,  United States
      Gary Richmond MD, Fort Lauderdale,  Florida,  33316,  United States
      CRI of South Florida, Coral Gables,  Florida,  33146,  United States
      Therafirst Med Ctr, Fort Lauderdale,  Florida,  33308,  United States
      Specialty Med Care Ctrs of South Florida Inc, Miami,  Florida,  33142,  United States
      Infectious Diseases Associates, Sarasota,  Florida,  34239,  United States
      Infectious Disease Research Inst, Tampa,  Florida,  33614,  United States
      Jeffrey Levenson, St. Petersburg,  Florida,  33710,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
      Med College of Georgia, Augusta,  Georgia,  30912,  United States
      SMO USA, Conyers,  Georgia,  30013,  United States
Indiana
      Indiana Univ Med School, Indianapolis,  Indiana,  46202,  United States
Massachusetts
      Brigham and Women's Hosp, Boston,  Massachusetts,  02115,  United States
      Hawthorne Med Associates / PAACA, New Bedford,  Massachusetts,  02745,  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
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
      VAMC New Jersey Healthcare System, East Orange,  New Jersey,  07018,  United States
New York
      SUNY / Erie County Med Ctr at Buffalo, Buffalo,  New York,  14215,  United States
      North Shore Univ Hosp, Manhasset,  New York,  11030,  United States
      Bronx Veterans Affairs Med Ctr, Bronx,  New York,  10468,  United States
      St Lukes - Roosevelt Hosp Ctr, New York,  New York,  10019,  United States
Ohio
      Univ of Cincinnati / Holmes Hosp, Cincinnati,  Ohio,  452670405,  United States
Pennsylvania
      Milton S Hershey Med Ctr, Hershey,  Pennsylvania,  170330850,  United States
      Hahnemann Univ Hosp, Philadelphia,  Pennsylvania,  19102,  United States
South Carolina
      Burnside Clinic, Columbia,  South Carolina,  29206,  United States
Tennessee
      Methodist Healthcare, Memphis,  Tennessee,  38104,  United States
Texas
      Joseph C Gathe, Houston,  Texas,  77004,  United States
      Nicholas Bellos, Dallas,  Texas,  75246,  United States

Study ID Numbers:  316B; APV30002
Record last reviewed:  March 2002
Last Updated:  October 13, 2004
Record first received:  January 23, 2001
ClinicalTrials.gov Identifier:  NCT00009061
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08