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A Study of 141W94 in Combination With Other Anti-HIV Drugs

Phase 1
Completed
Conditions
HIV Infections
Registration Number
NCT00002372
Lead Sponsor
Glaxo Wellcome
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

ViRx Inc

🇺🇸

San Francisco, California, United States

Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr

🇺🇸

Durham, North Carolina, United States

Univ of California / San Diego Treatment Ctr

🇺🇸

San Diego, California, United States

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