283 results
The aim of this study is to investigate what proportion of HBeAg negative, inactive carriers of the hepatitis B virus with low (< 20,000 IU/mL) load will lose HBsAg when treated with nucleot(s)ide analogue/Peg-IFN combination therapy.
The objectives are:- to provide access to telaprevir for subjects with chronic HCV genotype 1 infection who wererandomized to the control group in the C216 trial and who failed therapy for virologicreasons;- to evaluate efficacy, safety, and…
CD8 T-cell expansions in HIV patients, treated with HAART, who have long-term suppression of HIV-RNA
To determine the nature of these expanded CD8 T-cell subsets, by performing apoptosis resistance assays and phenotypic analysis of markers that are primarily found on so-called exhausted cells.
Primary: To determine the pharmacokinetics of oseltamivir in children and in adults with significant co-morbiditiesSecondary: To examine whether the pharmacokinetics in our studied populations are comparable with the PK in other populations To…
Primary objective is to assess the safety and reactogenicity during the entire study period in subjects aged 66 years (previously enrolled in the FLU NG-036 EXT 025 Y1 study) vaccinated with the FLU NG vaccine or with Fluarix*, and in subjects aged…
Main objective• To determine the safety and tolerability of multiple dosing of SPC3649Secondary objectives• To assess the pharmacokinetics (PK) of multiple dosing of SPC3649 administered by i.v. and s.c. route in healthy volunteers• To evaluate the…
The primary objective of this study is to demonstrate the superior antiviral efficacy of the combination of peginterferon alpha-2a plus telbivudine vs peginterferon alpha-2a monotherapy as demonstrated by HBV DNA non-detectability using the COBAS…
The primary objective of this study is to evaluate the efficacy of SCH 503034800 mg TID PO in combination with PegIntron 1.5 *g/kg QW SC plus ribavirin (800 - 1400 mg/day) in previously untreated adult chronic hepatitis C (CHC) subjects infected…
The objective of this study is to evaluate the concentrations in blood after a single administration of 100 mg TMC125. The various administration formulations will be compared to demonstrate that the formulations can be exchanged. The administration…
Primary objectives : to investigate the safety and tolerability of multiple oral doses of JTK-652 administered for 14 days to healthy male subjectsSecondary objectives : tot determine the pharmacokinetics of multiple oral doses of JTK-652…
Primary Objective:The primary objective of the maraviroc expanded access program is to facilitate access to maraviroc for subjects, who have limited therapeutic options and to collect safety data in a larger and more diverse patient population than…
- To evaluate the effect of steady-state TMC278 25 mg q.d. on the steady-state pharmacokinetics of R- and S-methadone.- To evaluate the potential effect of TMC278 on the pharmacodynamic effects of methadone therapy; - To evaluate the steady state…
The primary objective of this trial is to compare the immunogenicity and safety (local and systemic reactions) of a reduced dose intradermal IPV (NVI) booster vaccination administered with a jet injector to a standard full dose intramuscular IPV (…
Monitoring of resitance development in HIV
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.
Primary objective is to evaluate the HIV-1 specific immunity after two vaccinations with the HIV-1 specific recombinant vaccinia vaccine NYVAC-B, compared to placebo. Secondary objectives are the evaluate of the change in plasma HIV-1 RNA in…
The primary objective is to study the effect of a 16-week treatment with a PPAR-* agonist versus placebo on effectiveness of subsequent standard treatment with PEG-IFN and RBV, measured as SVR, in previously non-responders or relapsers with CHC…
This study involves research and the objective of this study is to investigate the effect of esomeprzole on the single-dose pharmacokinetics (i.e., how a drug moves through the body) of telaprevir. And to obtain additional data regarding the safety…
Primary : to investigate the safety, tolerability and antiviral activity of multiple oral doses of JTK-652 administered for 4 weeks in subjects with chronic hepatitis C infection (genotype 1a, 1b)Secondary : to investigate the pharmacokinetics of…
The objective of this study is to compare the bioavailability of 100 and 200 mg pills that are produced in different ways: coated or non-coated. Bioavailability means the amount of medication which is available for use in the body. In this study the…