A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects

Study start date: March 1, 1998

Inclusion Criteria Patients must have: Within 15 business days prior to randomization: CD4 cell count greater than or equal to 100 cells/mm3. HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Bilateral peripheral neuropathy. Intractable diarrhea. Proven or suspected acute hepatitis within 30 days prior to study entry. Concurrent Medication: Excluded: - Therapy for any co-existing disease that may interfere with patient ability to participate in this study. Concurrent Treatment: Excluded: Therapy for any co-existing disease that may interfere with patient ability to participate in this study. Patients with the following prior conditions are excluded: History of acute or chronic pancreatitis. Prior Medication: Excluded: Therapy for any previous disease that may interfere with patient ability to participate in this study. Excluded within 14 days prior to randomization: Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy. Excluded within 3 months of the start of this study or expected need at time of enrollment: Agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential. Inability to tolerate oral medication. Prior Treatment: Excluded: Therapy for any previous disease that may interfere with patient ability to participate in this study. Risk Behavior: Excluded: Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.