drugset / Trial / NCT00964327

TMC114-C201: A Study to Determine the Antiviral Activity of TMC114 in Patients With Multiple Protease Inhibitor (PI) Resistant Human Immunodeficiency Virus (HIV) Strains

NCT00964327

Phase 2 Completed 42 enrolled Tibotec Pharmaceuticals, Ireland
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the antiviral activity, safety and tolerability of 14 days of different doses of TMC114 to treat HIV-1 positive patients whose condition is failing on a current treatment regimen that includes a protease inhibitor (PI) (a medication used to reduce the amount of HIV virus in the blood).To be considered for the study, patients must have a documented resistance to at least 2 of the current PIs. Pharmacokinetics and pharmacodynamics of TMC114 will also be assessed.

Timeline

Start
2001-08
Primary completion
2003-10
Completion
2003-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 400 mg
Subject Darunavir Small molecule 800 mg
Subject Darunavir Small molecule 1200 mg