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

2014-08-27 03:59:14 | BioPortfolio

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.

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

Nelfinavir mesylate

Location

UCLA School of Medicine / Dept of Pediatrics
Los Angeles
California
United States
90024

Status

Completed

Source

NIH AIDS Clinical Trials Information Service

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:14-0400

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