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Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911.

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…

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults.

To assess non-inferiority of a regimen containing ritonavir-boosted elvitegravir versusraltegravir, each administered with a background regimen in HIV-1 infected,antiretroviral treatment-experienced adult subjects as determined by the proportion…

Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle.

Primary objectives: (1) Evaluation of the efficacy of vaccination against HPV 16, 18, 6 and 11 followed by local applications of imiquimod 5% cream compared to treatment with imiquimod alone for usual type VIN, (2) evaluation of the systemic and…

A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) in relapsed HCV-1 infected patients

The primary objective is: To evaluate the efficacy, safety and tolerability of NIM811 administered in combination with SOC in an interferon-relapser population of patients infected with chronic hepatitis C genotype-1.Secundary objectives are: * To…

A Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin with Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects

Primary: To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy(i.e. amantadine and ribavirin co-administered with oseltamivir) compared to oseltamivirmonotherapy in immunocompromised subjects diagnosed with Influenza…

A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment.

The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…

The effect of FOsamprenavir/Ritonavir on the pharmacokinetics of a single-dose of the antipsychotic agent olanZApine (FORZA)

Primary objective: To evaluate the influence of fosamprenavir/ritonavir on single-dose pharmacokinetics of olanzapine in healthy volunteersSecondary objective: To evaluate the safety of fosamprenavir/ritonavir combined with single-dose olanzapine in…

Phase I, open-label, randomized, crossover trial in healthy adults to compare the oral bioavailability of 3 concept pediatric formulations of TMC278 (solution, suspension, granules) to that of the adult 25 mg Phase III tablet formulation, and to assess the food effect for each concept formulation.

This study involves research and the objective of this study is to evaluate how much and how fast TMC278 is absorbed into the body after administration as these concept pediatric formulations compared to when administered as the 25 mg TMC278 tablet…

The effect of atorvastatine on the viral load in patients with chronic hepatitis C

Determine if maximum doses of atorvastatin are safe in patients infected with chronic hepatitis C and if the so called pleiotropic effects of atorvastatin cause a decrease in the HCV viral load.

Phase I, double blind, randomized, placebo-controlled trial in healthy subjects to examine the safety, tolerability and pharmacokinetics of increasing oral doses of TMC435350 after single and repeated dosing, followed by an open label repeated dosing session in 6 HCV-genotype 1 infected patients (non placebo-controlled).

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Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options.

The primary objective of this trial is to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple ARV regimens and have limited treatment options with the currently approved antiretrovirals.The…

A Phase 2 Study of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys??), and Ribavirin (Copegus??) in Subjects with Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response with a Prior Course of Interferon Based Therapy

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…

Obtaining Leukapheresis-derived Product from HIV-Infected Individuals

testing and validation of the procedures for the collection and the transport to the laboratory of the sponsor in the US (VIRxSYS, Gaithersburg, MD) of PBMC's donated via leukapheresis by HIV-1 infected persons in the Netherlands and the…

Monochloroacetic acid versus cryotherapy or combination therapy in the treatment of warts: A Randomised Clinical Trial (WARTS-2)

To assess the efficacy of treatment with monochloroacetic compared to treatment with cryotherapy regarding patients with handwarts and compared to combination therapy (salicylic acid and cryotherapy) regarding patients with plantar warts.WARTS-1 has…

Prednisolone Rhinosinusitis Efficacy Trial (PRET) study

To assess the effects of a 7-day course of 30 mg prednisolone daily in addition to usual care (symptomatic) treatment in adults with RS.

A prospective explorative cross sectional clinical study to investigate the neurocognitive effects of human Immunodeficiency virus and the influence of highly active anti retroviral (HAART) therapy on CSF viral replication and biomarkers for neurodegeneration in HIV infected patients on chronic therapy with HAART

1 To investigate the influence of HAART on CSF viral load, development of HIV resistance, neurotransmitters and biomarkers for neurodegeneration2 To explore the neurocognitive effects of HIV infection and its treatment3 To investigate the…

The influence of GINkGo biloba on the pharmacokinetics of the UGT substrate raltEgraviR (GINGER)

To determine the effect of chronic use of ginkgo biloba on the single-dose pharma-cokinetics (AUC0-inf, AUC0-12, Cmax, C12) of raltegravir 400mg in healthy volunteers.

Achieving appropriate exposuRe to RIBAvirin after a dose advise based on an abbreviated AUC of a first dose of ribavirin (ARRIBA)

Primary objective: To evaluate if adequate exposure to ribavirin can be achieved after a dose adjustment based on the AUC0-4h from a first dose of ribavirin.Secondary:• To evaluate how many patients need a dose adjustment to achieve adequate…

A phase IV, open label, randomized, multicountry study to evaluate immunogenicity and safety of GSK Biologicals' seasonal (2010-2011) influenza vaccine Fluarix in children previously vaccinated with GSK Biologicals' H1N1 vaccine (Pandemrix)

The objective of this study is to evaluate the immune respons against the H1N1 strain following vaccination with the first dose of trivalent inactivated influenza virus vaccine (Fluarix) in subjects previously vaccinated with 2 doses of H1N1…

A single ascending dose study to assess the safety, tolerability and pharmacokinetics of RO5428029 in healthy male subjects

To evaluate the safety, tolerability and pharmacokinetics of RO5428029 in healthy male subjects.