To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule
formulation (SQV-SGC) in combination with other antiretroviral drugs.
All patients receive SQV as monotherapy or in combination with other antiretroviral drugs
chosen by the investigator and patient. (This study provides only SQV.) Patients may not
choose another protease inhibitor (PI) as part of their combination therapy; furthermore,
patients taking PIs other than SQV must undergo a 5-day washout period before study-drug
administration. Patients are monitored for adverse events and changes in routine laboratory
tests, plasma viral load, and CD4+ T cell levels. Outcomes are analyzed by stratifying
patients according to CD4+ T cell levels and prior history with protease inhibitors.
Antiretroviral treatments other than PIs.
Patients must have:
- HIV infection.
- No prior experience with PIs. (Note:
- At least 75 percent of patients must be naive to PIs.)
PIs other than SQV.
Any PIs (see note in General Criteria--Inclusion).