The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs

Hoffmann-La Roche400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

400

Conditions

HIV Infections

Interventions

SaquinavirDRUG

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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).

Locations (1)

Consumer Contact

Nutley, New Jersey, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.