25 results
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…
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone.
This study is a Phase II, non-randomized, open label trial to evaluate Safety and Antiviral activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents.
The primary objective is to select one of two platinum strategies to be used in this regimen for use as experimental arm in Phase III. This is a screening feasibility study addressing purely investigational approaches.
Primary objective is to evaluate whether or not using antibiotics reduces to time to full recovery of an attack of uncomplicated (mild) diverticulitis. Secondary objectives are to evaluate complications, quality of life, readmission rate, recurrence…
This is a scientific research with the aim to investigate the bioavailability of a combination of the drugs TMC114 and TMC41629 . The three dosage forms, each only once ingested. In addition, even in this study the safety of the use and possible…
The objective of the study (phase 2) is to evaluate the effectiveness of AMG 102 in combination with Mitoxantrone and Prednisone in previously treated subjects with castrate resistant prostate cancer.
To assess clinical parameters and biomarkers in blood and urine in predicting bacteremia, need for hospital admission, clinical and bacteriologic cure and mortality in patients with fUTI.To determine whether a 7-day duration of antibiotic treatment…
The primary objective is to determine the absorption of orally administered antibiotics in patients with SBS, to guide in clinical decision making when faced with catheter related infections.
- To assess the effectiveness of rectal culture-guided antimicrobial prophylaxis for transrectal prostate biopsy (random ultrasound-guided, targeted MRI-guided or targeted MRI-ultrasound fusion guided) on infectious complications. - To compare the…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
In this study we want to assess the hepatic cyst penetration capacity of intravenously administered antibiotics (ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam) by comparing blood and cyst fluid concentrations in patients…
To demonstrate non-inferiority of oral fosfomycin-trometamol compared to oral ciprofloxacin as a step-down treatment for E.coli AF-UTI in women for the cumulative incidence of survival and clinical cure (resolution of symptoms) 6-10 days post-…
Primary objective: To study the pharmacokinetics of gentamicin, tobramycin, vancomycin and ciprofloxacin in morbidly obese patients and compare with normal weight patients. Secondary objectives: To assess the influence of covariates (such as TBW,…
The primary objectives are to determine the inhibitory effect of intravenously administered C1-inhibitor as well as the influence of depletion of the human microbiota on allergic lung inflammation induced by house dust mite (HDM) plus…
To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old
To determine the relative bioavailability of ciprofloxacin oral suspension versus oral tablets in pediatric cancer patients, and to determine the absolute bioavailability of tablets and suspension utilizing the 100% bioavailability of intravenous…
To suppress low-level viremia to a level below 50cp/mL in patients using cART by switching their current non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI to DRV boosted with ritonavir (RTV) (DRV/r). Secondary objectives are to reduce the…
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…