drugset / Trial / NCT00460382
Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses
Phase 2
Completed
103 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Janssen-Cilag Ltd. · collabMerck Sharp & Dohme LLC · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
Timeline
- Start
- 2007-05
- Primary completion
- 2008-03
- Completion
- 2009-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 600 mg | — |
| Subject | Etravirine | Small molecule | 200 mg | — |
| Subject | Raltegravir | Other / unclassified | 400 mg | — |
| Background | Enfuvirtide | Peptide | — | — |
| Background | Ritonavir | Other / unclassified | 100 mg | — |