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The added effect of oral ondansetron to care-as-usual on persisting
vomiting in children aged 6 months to 6 years, presenting at primary care
out of hours service with acute gastro-enteritis and concomitant vomiting

The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…

A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial

PrimaryIn HCV-infected subjects who have previously been treated with MK-5172 and received at least one dose:1. To evaluate the durability of SVR in subjects who remained HCV RNA LLoQ (either TND or TDu) throughout the follow-up period of the…

A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment

The primary objective of this study is:- To evaluate the effect of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) on renal parameters at Week 24The secondary objectives of this study are:- To…

Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men

The objective of the current proposal is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and intra-anal high-grade, HPV16 positive AIN, who failed on…

A Study to Evaluate the Relative Bioavailability and Effect of Food on Two Formulations of the MK-3682A Fixed-Dose Combination Tablets (MK-3682/MK-5172/MK-8742, 300 mg/ 100 mg/50 mg) in Healthy Adult Subjects.

Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…

A phase 1 open-label study to characterize the metabolism and excretion of a single dose of radiolabeled AL-335 administered in combination with Odalasvir and Simeprevir and administered alone in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent AL-335 is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). AL-335 to be administered will be labeled with 14-…

Immune phenotyping in chronic HCV patients treated with Sofosbuvir and Daclatasvir combination for 12 or 24 weeks * SODA study

Primary objectiveThe primary objective for this study is to analyse the impact of inhibition of viral replication by interferon-free therapy consisting of Sofosbuvir and Daclatasvir (±Ribavirin) on the phenotype and function of the innate immune…

A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection

Primary ObjectivesThe primary objectives are to evaluate in infants who are hospitalized with RSV infection:• the pharmacokinetics of JNJ-53718678 after multiple oral doses;• the safety and tolerability of JNJ-53718678 when administered for 7 days.…

Ledipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis. HepNed-001 study

To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotype 4 patients without cirrhosis.

Once daily DArunavir/ritonavir in HIV-infected children 6-12 years old: a PHarmacokiNEtic validation of model-based dosing recommendations (DAPHNE)

To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old

Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of ACUTE hepatitis C genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2)

The goal of this study is to document the efficacy of a shortened 8-week therapy with grazoprevir and elbasvir in patients with acute HCV genotype 1 or 4 infection.

A Kaletra ONCE daily Randomised Trial of the
pharmacokinetics, safety and efficacy of twice-daily
versus once-daily lopinavir/ritonavir tablets dosed by
weight as part of combination antiretroviral therapy in
HIV-1 infected children (PENTA 18).

Evaluating the current dosing guidelines in children taking the half-strength paediatric tablets will provide reassurance that the recommended lopinavir/ritonavir dose provides adequate drug exposure and maintains efficacy.This trial will evaluate…

A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon α-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

The primary objective of this study is to evaluate the efficacy of TDF plus Peginterferon *-2a (PEG) combination therapy for 48 weeks versus standard of care TDF monotherapy or PEG monotherapy for 48 weeks in non-cirrhotic CHB subjects as determined…

An Open-Label Study of GS-7977+ Ribavirin with or without Peginterferon Alfa-2a in Subjects with Chronic HCV Infection who Participated in Prior Gilead HCV Studies

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 (…

A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of protease inhibitors to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml

1. To assess the effect of the switch from protease inhibitors to raltegravir on endothelial function. 2. To assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on…

Bioequivalence study in healthy volunteers of a new paediatric formulation of valacyclovir used for prophylaxis and treatment of VZV and HSV infections in children, phase I (VALID I)

In this trial will be investigated if a new formulation of valacyclovir, e.g. oral solution, is bioequivalent to valacyclovir tablets. This comparison will be made by determining pharmacokinetic parameters (AUC0-*, Cmax, and tmax) of both…

Efficacy of 12 week boceprevir in addition to standard of care therapy consisting of peginterferon-alpha-2b and ribavirin for the treatment of acute HCV genotype 1 in HIV co-infected patients. A proof of concept feasibility clinical trial.

Document the efficacy and tolerability of 12 weeks of Boceprevir (Victrelis®) therapy in addition to standard of care (SOC) therapy consisting of weekly weight based peginterferon alfa-2b (Pegintron®) SC and ribavirin PO BID, for the treatment of…

MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV;Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…

Augmenting response to entecavir using a temporary peginterferon alpha-2a add-on strategy for the treatment of HBeAg-positive chronic hepatitis B (ARES study)
- Long-term follow-up of a peginterferon alpha-2a add-on strategy in chronic hepatitis B patients treated with entecavir

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-…

A pilot study on the efficacy and pharmacokinetics of a switch from nevirapine with emtricitabine, tenofovir or lamivudine, tenofovir or lamivudine, zidovudine to rilpivirine with emtricitabine, tenofovir in virologically suppressed HIV-1 infected patients.

Primary objective:To evaluate the efficacy of a RPV based HAART in patients that switch from NVP with FTC, TDF or lamivudine (3TC), TDF or 3TC, zidovudine (ZDV) to RPV/FTC/TDF.Secondary objectives:To measure the impact (strength and duration) of NVP…