VX-950-TiDP24-C124: A Phase I Trial to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state.
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|ClinicalTrials.gov Identifier: NCT00775125|
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : December 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Telaprevir HIV||Drug: Telaprevir; Darunavir; Ritonavir; Fosamprenavir||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label, Randomized, 2-way Crossover Trial in 40 Healthy Subjects to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state.|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
- Effect of steady-state DRV/rtv 600/100 mg b.i.d. and steady-state of fAPV/rtv 700/100 mg on the steady-state PK of telaprevir 750 mg q8h and 1125 mg q12h and vice versa. Steady-state PK on telaprevir 750 mg q8h and 1125 mg q12h alone.
- The secondary objective is to determine the short-term safety and tolerability of coadministration of telaprevir and DRV/rtv, and telaprevir and fAPV/rtv.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775125
|Study Director:||Tibotec-Virco Virology BVBA Clinical Trial||Tibotec BVBA|