TMC125-TiDP2-C197: A Phase I Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Volunteers.
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|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.
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): NCT00767117
|Study Director:||Tibotec Pharmaceuticals Clinical Trial||Tibotec Pharmaceutical Limited|