Inclusion Criteria
Patients must have:
- At least six months of prior cumulative ZDV therapy.
- Qualifying plasma HIV RNA count of >= 4 log10 copies/ml obtained within 2 weeks of randomization.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
- Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.
- Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days).
- Signs and symptoms of bilateral peripheral neuropathy >= grade 2 at the time of screening.
- Inability to tolerate oral medication.
- Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
Concurrent Medication:
Excluded:
- Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential.
- Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy.
Patients with any of the following prior conditions or symptoms are excluded:
- History of acute or chronic pancreatitis.
- Prior history of bilateral peripheral neuropathy.
- Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days) within 30 days prior to study entry.
Prior Medication:
Excluded:
- Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria).
- Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.
- Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir.
- Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen.
Risk Behavior:
Excluded:
- Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis.
Required:
At least 6 months of prior cumulative ZDV therapy.