A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

Roche

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Saquinavir; Drug: Ritonavir; Drug: Nelfinavir mesylate; Drug: Delavirdine mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002178

229J

NR15539

Details and patient eligibility

About

To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.

Full description

Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• HIV RNA >= 5000 copies/ml by Amplicor assay.
• Signed, informed consent from parent or legal guardian for patients less than 18 years old.

Previous treatment with antiretrovirals.