11 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…
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…
To decrease the cumulative incidence of (hematological) relapse
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…
To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old
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 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.
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…
Objectives. The goals of the current protocol is therefore the natural follow-up of the objectives achieved with the previous grants and, in particular, of projects designed to discern new models for the successful conduct of clinical trials in…
- 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…
Objectives: - to increase the proportion of patients with non-severe GVHD within 180 days post-allo-SCT - to reduce the progression rate - to improve the progression free survival- to asses the impact on the quality of life using a time restricted…