29 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…
The primary objective is to evaluate the antiviral efficacy of TMC435 in combination with PegIFN*-2a and RBV.In addition to this, the study provides access to TMC435 treatment in combination with PegIFN/RBV to (1) subjects whoparticipated in the…
The primary objectives of this study are:* To determine the efficacy of GS-7977 + RBV with or without Peginterferon alfa-2a (PEG) as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (…
To investigate the use of a temporary peginterferon alpha-2a add-on strategy during entecavir therapy in patients with HBeAg-positive chronic hepatitis B by comparing the efficacy of this regimen versus entecavir monotherapy.To evaluate the long-…
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 Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin inpatients with chronic hepatitis C viral (HCV) infection· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414)…
Primary:* To determine the efficacy of PSI-7977 in combination with RBV administered for 12 weeks compared with PEG/RBV administered for 24 weeks in treatment-naïve patients with HCV genotype 2 or 3 as assessed by the rate of SVR12 (HCV RNA of…
1. To determine the safety and tolerability of TMC649128/TMC619688 during multiple dosing in treatmentnaïve and treatment-experienced genotype 1 HCV-infected subjects at different dose regimens as 10-days and 14-days monotherapy.2. To determine the…
to study the safety and tolerability of HM10660A (LAPS-interferon alpha-2b), including immunogenicity, as compared to Pegasys® (PEG-interferon alpha-2a)to study the pharmacokinetics and pharmacodynamics of HM10660A (LAPS interferon alpha-2b) as…
Primary:To estimate the difference in SVR rates between T12/PR24 and T12/PR48 treatment regimens in subjects who achieve eRVR.Secondary:To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naïve subjects with…
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…
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 primary objectives of this trial are the following:- to determine the dose dependency of the antiviral effect of TMC435350 during 1 week ofmonotherapy in treatment-naïve HCV-infected subjects;- to determine the dose dependency of the antiviral…
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…
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.
To compare to control (Group A) (peginterferon alfa-2a [Peg IFN-*-2a] and ribavirin [RBV] for 48 weeks) the proportion of subjects who achieve sustained viral response (SVR, undetectable HCV RNA 24 weeks after completion of treatment) when given…
To provide access to a telaprevir-based treatment to subjects of the Control Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate response to treatment (according to treatment stopping rules). Safety, tolerability, and HCV…
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…