The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.

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

Further Study Details: 

Expected Total Enrollment:  210

Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.

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 required 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 (NNRT) or protease inhibitor (PI).
• Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
• 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 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
      Ocean View Internal Medicine, Long Beach,  California,  90803,  United States
      East Bay Clinical Trial Ctr, Concord,  California,  94520,  United States
Florida
      Hillsborough County Health Dept, Tampa,  Florida,  33602,  United States
      Florida ID Group, Orlando,  Florida,  32801,  United States
      Clinical Pharmacology Services, Tampa,  Florida,  33617,  United States
Illinois
      Veterans Affairs Med Ctr of North Chicago, Chicago,  Illinois,  60064,  United States
Kansas
      Univ of Kansas Med Ctr, Kansas City,  Kansas,  661607415,  United States
New Jersey
      UMDNJ - New Jersey Med School, Newark,  New Jersey,  071032757,  United States
      Saint Michael's Med Ctr, Newark,  New Jersey,  07102,  United States
New York
      Univ of Rochester Med Ctr, Rochester,  New York,  14642,  United States
      Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx,  New York,  10461,  United States
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States
      Howard Grossman, New York,  New York,  10011,  United States
      Brookdale Univ Hosp and Med Ctr, Brooklyn,  New York,  112123198,  United States
      Addiction Research and Treatment Corp, Brooklyn,  New York,  11201,  United States
      Gervais Frechette, New York,  New York,  10011,  United States
North Carolina
      SMO-USA Inc, Charlotte,  North Carolina,  28211,  United States
Oregon
      Advanced Clinical Trials Inc, Eugene,  Oregon,  97401,  United States
Pennsylvania
      Thomas Jefferson Univ, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Southwest Texas Methodist Hosp, San Antonio,  Texas,  78229,  United States
      MacGregor Med Association, Houston,  Texas,  77054,  United States
      Walter Gaman, Irving,  Texas,  75038,  United States
      Univ of Texas Med Branch, Galveston,  Texas,  775550835,  United States

Study ID Numbers:  316A; APV30001
Record last reviewed:  July 2001
Last Updated:  October 13, 2004
Record first received:  January 13, 2001
ClinicalTrials.gov Identifier:  NCT00008554
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08