ACTG 397--SAQUINAVIR COMBINATION THERAPIES IN HIV CHILD

$0M01FY2002RRNIH

Johns Hopkins University, Baltimore MD

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Abstract

The hypothesis of this Phase II trial is that two treatment combinations, indicated below, will be effective in reducing HIV viral load and will be well tolerated. Children will be randomized to one of the 2 following 2 treatment arms: Arm 1: Saquinavir soft gel capsule (50 mg/kg po TID; maximum, 1200 mg po TID), plus two nucleoside reverse transcriptase inhibitors (NRTIs) of choice Arm 2: Saquinavir soft gel capsule (50 mg/kg po BID; maximum 1200 mg po BID) plus nelfinavir (55 mg/kg po BID; maximum 1500 mg po BID) plus one or two NRTIs of choice The primary specific aim of this study is to assess the tolerance and safety of orally administered saquinavir soft gel capsule (SQV-SGC) given in combination with two NRTIs or orally administered SQV-SGC and nelfinavir and one or two NRTIs.

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