To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir, indinavir and nelfinavir after multiple oral dosing. To determine the steady-state pharmacokinetics of saquinavir, indinavir, and nelfinavir in combination with 141W94 after multiple oral dosing. To assess the safety and tolerability of multiple doses of 141W94 when combined with saquinavir, indinavir and nelfinavir.
Patients will be randomized to receive open label 141W94 in combination with saquinavir, indinavir and nelfinavir. The randomized phase will be preceded by a single dose pharmacokinetic interaction study of 141W94 and indinavir in 12 patients. Data from this single dose investigation will be used to determine the dose of indinavir to be used in the randomized phase.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
ViRx Inc
San Francisco, California, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, United States
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