5 results
To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…
This study is a Phase II, non-randomized, open label trial to evaluate Safety and Antiviral activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents.
The primary objective of this trial is to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple ARV regimens and have limited treatment options with the currently approved antiretrovirals.The…
The objective of this study is to evaluate the concentrations in blood after a single administration of 100 mg TMC125. The various administration formulations will be compared to demonstrate that the formulations can be exchanged. The administration…
Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…