drugset / Trial / NCT01818856
Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir
Phase 1
Completed
14 enrolled
Hospitales Universitarios Virgen del Rocío
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two analogues (NRTIs) in HCV/HIV-co-infected patients.
Timeline
- Start
- 2012-12
- Primary completion
- 2013-04
- Completion
- 2013-04
Publications
- Gutierrez-Valencia A, Ruiz-Valderas R, Ben-Marzouk-Hidalgo OJ, Torres-Cornejo A, Espinosa N, Castillo-Ferrando JR, Viciana P, Lopez-Cortes LF. Telaprevir and ribavirin interaction: higher ribavirin levels are not only due to renal dysfunction during triple therapy. Antimicrob Agents Chemother. 2015;59(6):3257-62. doi: 10.1128/AAC.04795-14. Epub 2015 Mar 23.
- Gutierrez-Valencia A, Ruiz-Valderas R, Torres-Cornejo A, Viciana P, Espinosa N, Castillo-Ferrando JR, Lopez-Cortes LF. Role of ritonavir in the drug interactions between telaprevir and ritonavir-boosted atazanavir. Clin Infect Dis. 2014 Jan;58(2):268-73. doi: 10.1093/cid/cit693. Epub 2013 Oct 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atazanavir | Other / unclassified | 200 mg | — |
| Subject | Atazanavir | Other / unclassified | 300 mg | — |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
| Subject | Telaprevir | Small molecule | 750 mg | — |
| Subject | Telaprevir | Small molecule | 1125 mg | — |