drugset / Trial / NCT00896051
TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and anti-HIV effect of this regimen will also be studied. A total of 46 patients will be enrolled.
Timeline
- Start
- 2009-08
- Primary completion
- 2012-04
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | 300 mg | Oral |
| Subject | Atazanavir | Other / unclassified | 400 mg | Oral |
| Subject | Etravirine | Small molecule | 200 mg | — |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |