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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 400 mg | — |
| Subject | Darunavir | Small molecule | 800 mg | — |
| Subject | Darunavir | Small molecule | 1200 mg | — |