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A multi-center, prospective, blinded validation study to assess the accuracy of a host-response based diagnostics for distinguishing between bacterIal and viral etiology in pediatric patients with lower respiratory tract infections and fever without source

To externally validate the accuracy of a host-response based diagnostics for differentiating between bacterial and viral etiology in pediatric patients aged 2 to 60 months with LRTI or FWS.

A Phase 3, Open Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically Suppressed, HIV 1 Positive Subjects

The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, and GT6 Infection

Primary Objective(s) & HypothesisObjective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy…

Bioequivalence of Crushed Stribild with a normal breakfast or with drip feed compared to the whole tablet.

Primary objective:To assess the bioequivalence of single dose STB after administration of standardized breakfast followed by a whole tablet (reference) and a crushed and suspended tablet (intervention I).To assess the bioequivalence of single dose…

Effect of Switching Atripla to Eviplera on neurocognitive and emotional functioning

This study aims to investigate the effect of switching from Atripla® to Eviplera® on neurocognitive performances (neurocognitive testing) and imaging (functional MRI scanning) in virologically suppressed HIV-infected patients and stable on atripla.

A Study to Evaluate the Comparative Bioavailability of One Tablet of 480 mg MK-8228 and Two Tablets of 240 mg MK-8228 Under Fasted Conditions in Healthy Subjects

- To compare the primary pharmacokinetic parameters AUC0-last, AUC0-*, and Cmax of MK-8228 after single dose administration of one tablet of 480 mg MK-8228 (test) and two tablets of 240 mg MK-8228 (reference) under fasting conditions.- To compare…

The role of innate lymphoid cells in asthma and rhinovirus-induced asthma exacerbations

This study aims to determine whether the ILC populations differ in the lungs of different phenotypes of asthmatic patients and healthy subjects and how these cells are regulated by bronchial epithelial cells. Furthermore we want to study how this is…

Osteoporosis and Activation Study of the Immune System in HIV

In this exploratory pilot study, we aim to investigate the role of immune activation in osteoporosis in HIV-infected patients on HAART with proven osteoporosis/ osteopenia in comparison to HIV-infected patients on HAART without osteoporosis/…

Immunogenicity and safety of an adjuvant hepatitis B vaccine (fendrix) compared to Engerix in non-responding HIV-infected patients

To study the immunogenicity and safety of adjuvanrt hepatitis B vaccin (Fendrix) compared to double-dosage of Engerix vaccination in HIV infected patients, previously failing HBV vaccinations.

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-…

Optimalization of the response to influenza virus vaccination in breast cancer and colorectal cancer patients immunocompromised due to chemotherapy

To evaluate the effect of chemotherapy on the serological and cellular immune response to influenza virus vaccination in patients with breast or colorectal cancer in order to establisch the optimal timing of vaccination during treatment with…

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…

Activation and apoptosis of peripheral T cells in relation to liver fibrosis

The primary objective is to explore the association between peripheral T-cell activation and apoptosis and hepatic fibrosis in various underlying liver diseases. Secondary objectives are 1) to investigate whether level of T cell activation and…

A Phase 1, randomized, double-blind, controlled trial to evaluate the safety and immunogenicity of increasing intranasal doses or of three intramuscular doses of the adjuvant Gram-positive Enhancer Matrix (GEM) administered with a standard dose of trivalent inactivated influenza vaccine (TIV) antigens, compared to a standard dose of TIV antigens administered either intranasally or intramuscularly in healthy adult volunteers; followed by a randomized, double-blind, controlled evaluation of safety

To assess the safety, reactogenicity, and tolerability of increasing GEM intranasal doses (1.25 mg, 2.5 mg and 5.0 mg) and intramuscular doses (0.05, 0.1, 0.2 mg) of the GEM adjuvant, each administration containing as well a standard 2010/2011 Flu…

Liver Toxicity in children with HIV Infections, case controle study (LITHI study)

The objective of this study is to gain insight in HIV infected children in the AMC in:.- the prevalence and clinical signs of livertoxicity - an association between the different compounds of combination anti-retroviral therapy (cART) and…

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)…

The ART-NECO study;Long term effective combination antiretroviral therapy (cART) and its effect on neurocognition. A prospective cohort study to assess the feasibility of two short cognitive screen tests in patients infected with HIV1 and the development of neurocognitive impairment over time

To examine neurocognition in 100 HIV1 seropositive patients on chronic effective cART using three different tests: the Montreal cognitive assessment (MoCA) , the International Aids Dementia scale (ADS) and extensive neuropsychological testing of…

Eurosupport 6: Testing the effectiveness of a computer-assisted counselling intervention on safer sex (CISS) for people living with HIV (PLHIV)

- To develop evidence-based and theory-guided target group specific interventions to improve the SRH of two specific groups of PLHIV, MSM and migrants, with particular emphasis on reduction of HIV transmission behaviour.- To test the effectiveness…