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Safety and protective efficacy of BCG vaccination against controlled human malaria infection

The primary objective is to determine the safety and tolerability BCG vaccination followed by controlled human malaria infection; and to determine the protective efficacy BCG vaccination against a controlled human malaria infection.

CRP-POCT in suspected airway infected patients in the long-term care facility

The main objective is to investigate the additional value of CRP-POCT (C-reactive protein point-of-care-test) testing in patients suspected of airway infections in long-term care facilities.

The role of paroxetine in patients taking telaprevir-based HCV therapy: lack of a drug-drug interaction? (ROLEX)

Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…

Pharmacokinetic and safety pilotstudy of RAltegravir and atazanavir in a once DAily dose regimen in HIV-1 in-fected patients (PRADA)

Primary: To compare the pharmacokinetics of raltegravir 400 mg twice daily vs. ralte-gravir 800 mg once daily (QD) by intrasubject comparison. Secondary: To determine the efficacy of an antiretroviral regimen consisting of raltegravir 800mg QD,…

A multiple dosing study to demonstrate the safety, tolerability, pharmacokinetics and efficacy potential of intravenously administered ANXV (a recombinant human Annexin A5) in patients with confirmed moderate to severe COVID-19; The CO-ANNEXIN Study.

Primary Objective:To evaluate the efficacy potential, safety and tolerability of intravenously administered ANXV, in ascending doses, and two different dosing regimens, in patients with confirmed moderate to severe COVID-19.Secondary Objectives:To…

A PHASE II, RANDOMISED, ADAPTIVE, OPEN-LABEL
PLATFORM TRIAL TO EVALUATE EFFICACY AND
SAFETY OF MULTIPLE COMBINATION THERAPIES IN
PARTICIPANTS WITH CHRONIC HEPATITIS B

Primary* To estimate the effect of NME combination therapies on inducing a functional cure over the control arm.Secondary * To characterize the efficacy profile of NME combination therapies.* To characterize the PD profile of NME combination…

Safety of Rifampicin at High Dose for the Treatment of Adult Subjects with Complex Drug Susceptible Pulmonary and Extrapulmonary Tuberculosis

Primary Objective: To evaluate the safety of high-dose rifampicin (35 mg/kg/d) supplemented with standard doses of isoniazid, pyrazinamide, and ethambutol for 8 weeks in adult subjects with pulmonary or extrapulmonary DS-TB belonging to difficult to…