HIV Infections
Conditions
Keywords
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Brief summary
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.
Detailed 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).
Interventions
Sponsors
Hoffmann-La Roche
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed