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A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…

Pharmacokinetic study of the HCV protease inhibitor bocePRevir and the proton pump inhibitor OMeprazOle (PROMO)

Primary objectiveTo determine the effect of multiple dose OME on the pharmacokinetics (AUC0-8h, Cmax, C8h) of BOC.Secondary objectives:To determine the effect of steady state BOC on the pharmacokinetics (AUC0-8h, Cmax, C8h) of multiple dose OME.To…

Pharmacokinetic study of the HCV protease inhibitor bO-cePrevir and the HIV integrase inhibitor rALtegravir (OPAL)

Primary objectiveTo determine the effect of steady state boceprevir on the pharmacokinetics (AUC0-12h, Cmax, C12h) of a single dose raltegravir.Secondary objectives:To determine the effect of a single dose raltegravir on the pharmacokinetics (AUC0-…

Safety and immunogenicity of seasonal and pandemic inactivated whole virion influenza vaccine in healthy adults

The goal of this study is to assess the safety and immunogenicity of the seasonal and pandemic inactivated whole virion influenza vaccines produced with the production process set up by the NVI for technology transfer (proof of principle).

An open-label randomised two-year trial comparing two first-line regimens in HIV-infected antiretroviral naïve subjects:
darunavir/r + tenofovir/emtricitabine vs. darunavir/r + raltegravir

Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…

TREATMENT WITH CMV PP65 SPECIFIC T CELLS GENERATED BY USE OF A CMV PP65 PROTEIN-SPANNING PEPTIDE POOL IN PATIENTS WITH CMV REACTIVATION OR CMV DISEASE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION

• To assess the feasibility, tolerability and safety of administration of donor or patient derived CMV pp65-specific T cells in patients with CMV reactivation or CMV disease after alloSCT.• To determine the presence of CMV specific T cells at…

The efficacy of mepolizumab treatment on rhinovirus induced asthma exacerbations

With this project we aim to determine the efficacy of anti-IL-5 treatment (mepolizumab) on virus-induced exacerbations in allergic asthma patients.Specific research questionsDoes IL-5 neutralisation:1) reduce the inflammatory response (T cell…

An open-label trial with TMC278 25 mg q.d. in combination with a
background regimen containing 2 nucleoside/nucleotide reverse
transcriptase inhibitors in HIV-1 infected subjects, who participated in
TMC278 clinical trials.

Primary ObjectiveThe primary objective of the trial is to provide continued access to TMC278 for subjects who were randomized andtreated with TMC278 in the Phase IIb (e.g., TMC278-C204 [C204]) or Phase III trials (e.g., TMC278-TiDP6-C209[ECHO] and…

A ONE-WAY DRUG DRUG INTERACTION STUDY TO ASSESS THE EFFECT OF EFAVIRENZ ON THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF BMS-790052 IN HEALTHY SUBJECTS

Primary: To assess the effect of multiple oral doses of 600 mg efavirenz once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary: To assess the safety of multiple oral doses of BMS-790052 given alone and together with…

An Open-Label Two-Way Drug-Drug Interaction Study to Assess the Effect of Tenofovir on the Pharmacokinetics of BMS-790052 and the Effect of BMS-790052 on the Pharmacokinetics of Tenofovir in Healthy Subjects

The purpose of the study is to investigate the effect of multiple oral doses of Tenofovir on how quickly and to what extent BMS-790052 is absorbed and eliminated from the body and the effect of multiple oral doses of BMS-790052 on how quickly and to…

A One-Way Drug-Drug Interaction Study to Assess the Effect of Ritonavir-boosted Atazanavir on the
Pharmacokinetics, Safety and Tolerability of BMS-790052 in Healthy Subjects

Primary Objective: To assess the effect of multiple oral doses of atazanavir 300 mg + ritonavir 100 mg once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary Objective(s): To assess the safety of multiple oral doses of BMS-…

A Phase I/IIa Study Assessing Single and Multiple Doses of study drug in Healthy and Genotype 1 HCV-Infected Subjects

Primary:* To evaluate safety and tolerability.* To evaluate antiviral activity.Secondary:* To evaluate plasma and urine PK.* To evaluate the effect of food on the PK of the study drug.

A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylaat Administered with Ribavirin

- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…

A Phase Ib, double-blind, randomized, placebo-controlled trial in genotype 1 HCV-infected patients to determine the safety, tolerability, pharmacokinetics and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin

1. To determine the safety and tolerability of TMC649128/TMC619688 during multiple dosing in treatmentnaïve and treatment-experienced genotype 1 HCV-infected subjects at different dose regimens as 10-days and 14-days monotherapy.2. To determine the…

A randomized, double-blind placebo- and active-controlled study of the pharmacokinetics, pharmacodynamics and safety of single ascending doses of HM10660A (LAPS-Interferon Alpha-2B) in healthy male subjects

to study the safety and tolerability of HM10660A (LAPS-interferon alpha-2b), including immunogenicity, as compared to Pegasys® (PEG-interferon alpha-2a)to study the pharmacokinetics and pharmacodynamics of HM10660A (LAPS interferon alpha-2b) as…

Long-Term Follow-Up of Subjects in a Phase 1, 2, or 3 Clinical Trial in Which Boceprevir or Narlaprevir was Administered for the Treatment of Chronic Hepatitis C.

This study will be conducted in two parts as described below:Part 1 will include subjects who participated in a Phase 1, 2, or 3 clinical study in which boceprevir was administered.Part 2 will include subjects who participated in a Phase 1, 2, or 3…

The BOKITO-1B study: tenofovir DF bone and kidney toxicity. Pharmacology in HBV-monoinfected patients.

The main objective of this study is to compare the incidence of KPTD in mildly renally impaired HBV-infected persons on TDF to the incidence in patients with normal renal function. Secondary goals are to relate tenofovir plasma, intracellular and…

Lowering viral load with nucleos(t)ide analogues prior to peg-interferon alfa-2b treatment to increase sustained response in HBeAg-positive chronic hepatitis B (PADD-study)

To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral loadDetermine the effect of PEG-IFNa on NK cell function and…

The BOKITO-2B Study: Tenofovir DF Bone and Kidney Toxicity.;Incidence and reversibility in HBV-monoinfected patients.

The main objective of this study is to assess incidence of, clinical determinants for, dose reduction in and reversibility of tenofovir associated renal insufficiency and KPTD.Secondary objectives are to assess kidney tubular function in patients…

Long term clinical outcome of treatment for chronic hepatitis C in patients with advanced fibrosis

The aim of this study is to determine the clinical benefit of effective antiviral treatment in patients with advanced fibrosis due to chronic hepatitis C infection.