9 results
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…
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…
Primary: Evaluate new influenza A (H1N1) disease (pandemic influenza) incidence of vaccinated compared to unvaccinated individuals. Secondary: * Obtain data on immunogenicity of pandemic influenza vaccination:- Evaluation of the humoral immune…
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…
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…
Primary Objectives: • To determine the basic immunity against influenza H1N1 (2009) in the population.• To determine the humoral and cellular immunity after a single vaccination with Influenza A virus (H1N1) 2009 Monovalent MF59- Adjuvanted Vaccine…
To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old
- 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…
- 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…