drugset / Trial / NCT00437476
Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-HCV Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in patients naive for HIV and HCV. Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART.
Timeline
- Start
- 2007-02
- Primary completion
- 2010-07
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lopinavir | Other / unclassified | 200 mg | — |
| Subject | Ritonavir | Other / unclassified | 50 mg | — |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | — |
| Background | Ribavirin | Small molecule | 1 g | — |
| Background | Ribavirin | Small molecule | 1.2 g | — |