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Infection serology in persons with putative exposure to flaviviruses through imported Aedes albopictus mosquitoes in the Netherlands

To make a risk estimation of the risk for public health, research is needed about:1. How many Ae. Albopictus are being introduced in the Nederlands?2. Does Ae. albopictus settle permanently in the Nederlands? If yes, where?3. Do the imported…

A Phase I, open-label, randomized, 2-way crossover trial in 40 healthy subjects to investigate the potential pharmacokinetic interactions between telaprevir and darunavir/ritonavir and between telaprevir and fosamprenavir/ritonavir at steady-state

The primary objective is to determine the effect of co-administration of telepravir, given as 2 tablets of 375 mg every 8 hours and DRV/rtv or fAPV/rtv on the amount of telaprevir and DRV/rtv or fAPV/rtv in the body. The secondary objective is to…

The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA)

In vitro data indicate that raltegravir is not a substrate of UGT1A4 or UGT2B7, but there is no evidence that raltegravir itself does not influence metabolism of other agents mediated by either UGT1A4 or UGT2B7.

Ribavirin: its dosing regime

Is the area under the curve (AUC) of the dose ribavirin once daily equal to the AUC of a half dose twice daily?

A blinded, randomized, placebo-controlled trial in genotype 1 hepatitis C-infected subjects to evaluate the efficacy, safety, tolerability and pharmacokinetics of repeated doses of TMC435350, with or without peginterferon alpha-2a and ribavirin.

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…

A Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106 Who did not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

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…

A Phase I, open-label, randomized, 2-way crossover trial in 2 parallel panels of 20 healthy subjects each to investigate the pharmacokinetic interaction between lopinavir/ritonavir (LPV/rtv) and telaprevir, and between atazanavir/ritonavir (ATV/rtv) and telaprevir, all at steady-state.

The first aim of the study is to investigate the effect of telaprevir on the concentration of LPV/rtv and ATV/rtv in the blood and the effect of LPV/rtv and of ATV/rtv the concentration of telaprevir in the blood.The second aim is to investigate the…

"HIV (ge) VAT" Vascular care in HIV infected patients; Reduction of vascular risks in HIV-1 infected patients
A pilot study

To study the impact of treating potentially modifiable vascular risk factors in HIV-1 infected patients by a nurse-led vascular intervention program

A Phase IIa randomized, open-label study of telaprevir (VX-950) administered every 12 or every 8 hours in combination with either Peg-IFN alfa2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment naive subjects with chronic genotype 1 hepatitis C infection.

The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics, and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with Peg IFN alfa2a (…

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection who are on Opiate Substitution Therapy.

3.1 Primary Objective(s): 1) Objective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety ad Efficacy of GS-9620 for the Treatment of Virally-Suppressed Subjects with Chronic Hepatitis B

The primary objectives of this study are:• To evaluate the safety and tolerability of GS-9620 in subjects with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV)• To evaluate the efficacy of GS-9620 at Week 24…

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA* Once-Daily in Treatment-Naïve HIV-1 Infected Subjects

The primary objectives are:In HIV-1 positive, treatment-naive subjects with pre-treatment HIV RNA * 1,000 copies/mL:1) To evaluate the non-inferior antiretroviral activity of MK-1439A q.d. compared to ATRIPLA q.d. as measured by the proportion of…

A Phase 3, Randomized, Double-Blind Study to Evaluate the
Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/
Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/
Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1
Positive, Antiretroviral Treatment- Naïve Adults

The primary objective of this study is:• To evaluate the efficacy of a single-tablet regimen (STR) containingelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STRcontaining elvitegravir/cobicistat/emtricitabine/…

Pharmacokinetics, safety and efficacy of atazanavir /dolutegravir/lamivudine regimen as maintenance regimen in patients with intolerance and/or resistance to NRTIs, NNRTIs and RTV: a pilot study (PRADA II study)

Primary objective:To assess the pharmacokinetics of the alternative maintenance QD regimen combining atazanavir, dolutegravir and lamivudine in HIV infected patients. Secondary objectives:To asses short term efficacy of the combination of atazanavir…

A drug-drug interaction study between the novel anti-HCV agent DAclatasvir and The antidiabetic agent mEtformine in healthy volunteers.

Primary objective:•To assess the effect of multiple dose daclatasvir (60mg QD) on the pharmacokinetics (AUC, Cmax, Ctrough, CLr) of multiple dose metformin (1,000mg BID) by intra-subject comparison, in healthy subjects.Secondary objective:•To assess…

A drug-drug interaction study between the novel anti-HCV agent daclatasvir and the antiretroviral agents atazanavir/ritonavir or atazanavir/cobicistat in healthy volunteers.

Primary objective:To compare the effect of multiple dose atazanavir/cobicistat on the multiple dose phar-macokinetics of daclatasvir with the effect of atazanavir/ritonavir on the multiple dose of daclatasvir by intra-subject comparison in healthy…

A phase 1, open-label study to characterize the absorption, metabolism and excretion of
14C-JNJ-63623872 after a single dose in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent JNJ-63623872 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The compound to be administered will be…

Safety and immunogenicity of HBAI20 adjuvanted Hepatitis B vaccine in naive adults and non-responders

In the current study we investigate the safety of the HBAI20 vaccine. Furthermore, the efficacy of the HBAI20 vaccine in non-responders is investigated.

A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection with Advanced Cirrhosis and Child-Pugh (CP)-B Hepatic Insufficiency.

The Primary Objectives are:(1) To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA…

The effect of oral ondansetron on referral rate in children aged 6 months to 6 years attending in primary care out of hours service with acute gastro-enteritis and vomiting.

The primary objective is to study the effect of oral Ondansetron and oral rehydration therapy on the number of referrals to a pediatric emergency department in children aged 6 months to 6 years attending an out-of-hours primary care service (OHS)…