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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside antiretroviral drugs (part 2), in HIV-infected infants and children.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Anti-Retroviral Agents; Nelfinavir; Saquinavir

Criteria

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.