A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

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.