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MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV;Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…

Effects of oxygen status on Hypoxia Inducible Factor 1-α. A pilot proof of principle study.

The primary objective of the study is to determine the effects of hyperoxia and hypoxia in healthy volunteers on kinetics of HIF1α mRNA in circulating leukocytes. Secondary objectives are to determine the effects of hyperoxia and hypoxia on HIF1α…

Dose modifications of the new Kaletra Meltrex tablets when combined with rifampin in healthy volunteers (DAKTARI)

Primary objective:- To evaluate dose modifications of the new Kaletra Meltrex tablets (lopi-navir/ritonavir 200/50 mg) when combined with rifampicin in healthy volunteersSecondary objectives:- To evaluate the safety of combined use of the new…

A Phase IIa randomized, open-label study of telaprevir (VX-950) administered every 12 or every 8 hours in combination with either Peg-IFN alfa2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment naive subjects with chronic genotype 1 hepatitis C infection.

The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…

A single dose study to evaluate the microdose pharmacokinetics of candidate HIV integrase
strand transfer inhibitors in healthy subjects

The purpose of the study is to investigate to what extent L-1, L-2 and L-3 are tolerated when administered as micro-dose.It will also be investigated how quickly and to what extent L-1, L-2 and L-3 are absorbed and eliminated from the body (this is…

Fluconazole versus Micafungin in neonates with suspected or culture-proven Candidiasis: a randomized pharmacokinetic and safety study

Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…

The effect of postoperative glucose control with a basal bolus versus a sliding scale insulin regimen on the incidence of surgical site infections in people with type 2 diabetes mellitus: A multicentre, matched-pair, cluster-randomised controlled trial

The aim is to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to a widely used reactive sliding scale regimen. It is hypothesised that a proactive basal-bolus insulin regimen targeting glucose levels of 3.9-10…