The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs
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To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.
Condition or disease
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.
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Ages Eligible for Study:
13 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Antiretroviral treatments other than PIs.
Patients must have:
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).