The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children

Inclusion Criteria

Patients must have:

• HIV infection according to standard definitions employed by the Pediatric AIDS Clinical Trials Group.
• Laboratory evidence of immunosuppression (Centers for Disease Control and Prevention [CDC] categories 2 and 3), or symptomatic HIV disease (CDC categories A, B, and C).
• At least 4 patients (2 in each parts 1 and 2) will be enrolled in each of three age strata:
• 6 months to 2 years; greater than 2 years to 6 years; and greater than 6 years to 13 years. NOTE:

• For the purposes of analysis only, patients will be stratified by age.

  1. Patients must be protease inhibitor therapy naive.

• Antiretroviral agents other than those prescribed by the investigator.
• Biologic response modifiers (other than erythropoietin, G-CSF, short course [<14 days] corticosteroids, or intravenous immune globulin).
• Other investigational drugs.
• Drugs known to significantly interact with saquinavir and/or nelfinavir. Patients must be protease inhibitor therapy naive.