NCT00002164

Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Agouron Pharmaceuticals · Industry
• Sex: All
• Age: 1 Day – 13 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.

Detailed description

This is a study of the safety, tolerability and pharmacokinetics of a Viracept pediatric powder formulation with milk or formula. First a single dose will be administered. After the patient population is divided into 4 groups by age, an optimal dose will be determined for each group. This optimal dose will be given 3 times a day for a 6 week primary observation period, plus an optional 6 month extension. NOTE: During the single dose portion of this study, patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy. During multiple dose administration of Viracept, antiretroviral therapy will be intensified by either adding or modifying therapy. Antiretroviral therapies will be limited to those currently licensed including zidovudine, lamivudine, stavudine, didanosine or zalcitabine.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Nelfinavir mesylate

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States