The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).
In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children \< 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
210
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, United States
Saint Jude Children's Hosp / Dept of Infect Diseases
Memphis, Tennessee, United States
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