HIV Infections Clinical Trial
Official title:
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
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.
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.
;
Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
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