412 results
OT population excludes patients lost to follow-up, or that discontinued DTG for reasons of intolerance or toxicity. ITT = all patients that took at least 1 DTG tabletPrimary objective:* To evaluate the efficacy of DTG monotherapy in maintaining…
MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…
The primary objectives of this study are:• To evaluate the safety and tolerability of GS-9620 in subjects with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV)• To evaluate the efficacy of GS-9620 at Week 24…
Our hypothesis in patients admitted to the ICU because of septic shock is that fluid loading guided by transpulmonary thermodilution derived stroke volume variation (SVV) and extravascular lung water (EVLW) results in more ventilator free days (VFDs…
The main objective of this study is to investigate the effectiveness of the self-help program compared to a waiting-list control group in reducing depressive symptoms. Secondary objectives include the investigation of moderators and mediators of…
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…
Primary Objective: In the CORAL study we want to determine whether increasing the inoculation dose of diarrhoeagenic E. coli to 5*10^10 CFU and addition of a second challenge 1*10^10 CFU will result in an increased effect-size and duration of…
In the current study we investigate the safety of the HBAI20 vaccine. Furthermore, the efficacy of the HBAI20 vaccine in non-responders is investigated.
The primary objective of the study is to establish the ocular safety and tolerability, and systemic safety of 3 different concentrations of preservative-free PHMB in healthy subjects.
The aim of this study is to evaluate if IV albumin administration improves short-term survival in patients with advanced cirrhosis (serum creatinine * 1.2 mg/dl, serum sodium * 130 mEq/l and/or serum bilirubin *4 mg/dl), signs of systemic…
The primary objectives are:In HIV-1 positive, treatment-naive subjects with pre-treatment HIV RNA * 1,000 copies/mL:1) To evaluate the non-inferior antiretroviral activity of MK-1439A q.d. compared to ATRIPLA q.d. as measured by the proportion of…
Main objective:- To evaluate the non-inferiority of switching to the FTC/RPV/TAF FDC as compared to continuing FTC/RPV/TDF FDC in virologically suppressed HIV-1 infected subjects as determined by maintaining HIV-1 RNA < 50 copies/mL at Week…
Primary objective:To determine whether endotoxin tolerance can be prevented by acetylsalicylic acid prophylaxis or can be reversed by acetylsalicylic acid treatment, expressed as an augmentation of pro-inflammatory cytokine levels during the second…
Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.
The primary objective of this randomized controlled trial is to compare the clinical effect of decontamination of the implant surface during the non-surgical treatment of peri-implantitis using air polishing or ultrasonic treatment. Secondary…
Primary endpoint: Evaluation of the safety of the novel anti-TB vaccine RUTI® (25*g FCMtb) in patients with MDR-TB favourably responding to second-line, standard MDRTB treatment through clinical, microbiological, and radiological response criteria.…
To assess the safety, tolerability and pharmacokinetic/-dynamic response, of single escalating doses of ADRECIZUMAB (0.5 mg/kg, 2mg/kg and 8 mg/kg administered as single infusion over 1 hour) in healthy male subjects.
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…
Primary objective: Does a personalised behaviour intervention comprising of targeted in depth screening on mental health problems and drug use increase help seeking behaviour among MSM who are at high risk for STIs and HIV. Secondary objectives:…
To evaluate the effect on severity of dyspnoea of administration of oxygen through High Flow Nasal Cannula compared to oxygen delivery through Low Flow Nasal Prongs in children hospitalized for bronchiolitis with moderate to severe dyspnoea.