HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Dosage Forms, Anti-HIV Agents
Brief summary
To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.
Detailed description
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.
Interventions
DRUGSaquinavir
Sponsors
Hoffmann-La Roche
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: 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.)
Exclusion criteria
Concurrent Medication: Excluded: PIs other than SQV. Prior Medication: Excluded: Any PIs (see note in General Criteria--Inclusion).
Countries
United States
Outcome results
None listed