drugset / Trial / NCT00460746
Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
Phase 3
Completed
10 enrolled
Tibotec, Inc
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are to remain unchanged.
Timeline
- Start
- 2007-05
- Primary completion
- 2008-10
- Completion
- 2008-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 200 mg | Oral |
| Subject | Darunavir | Small molecule | 600 mg | Oral |
| Subject | Etravirine | Small molecule | 200 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |