TMC125-TiDP2-C197: A Phase I Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Volunteers.
|ClinicalTrials.gov Identifier: NCT00767117|
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Etravirine; Lopinavir; Ritonavir||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-label, Randomized Cross-over, 2-period, 2-way Interaction Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Subjects.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
- Determine the effect of steady-state concentrations of LPV/low dose ritonavir, on the steady-state pharmacokinetics of TMC125 and vice versa.
- Evaluate the short-term safety and tolerability of the concomitant use of TMC125 and LPV, co-administered with low-dose ritonavir in healthy volunteers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767117
|Study Director:||Tibotec Pharmaceuticals Clinical Trial||Tibotec Pharmaceutical Limited|