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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 phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

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…

Immunological effect of early extra MMR immunization in infants between 6 and 12 months of age in an outbreak setting

Main: To assess the effect of an early extra measles immunization between 6and 12 months of age on the development of humoral and cell-mediatedimmunity against measles following routine MMR immunization at 14months of age.Secundary:Determine effect…

The role of the intestinal microbiome in enteric and systemic vaccine immune responses

Primary Objective: to investigate the role of the gut microbiota in RVV immune response Secondary Objectives: To investigate the role of the gut microbiota in tetanus and pneumococcal vaccine immune responses

A two-stage, controlled, open-label, dose-ascending first-in-man study to assess the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine

To evaluate the safety, tolerability and immunogenicity of a Twincer®-administered dry powder influenza vaccine in healthy adults.

Exhaustion of T cells in HIV-1 and HIV-2 infection

1. Determine whether different classes of epigenetic modifiers affect HIV-1-specific T cell immunity.a. Investigate whether HIV-specific T cell exhaustion can be reversed by inhibitors of different classes of epigenetic modifiers.b. Examine whether…

Follow-up of the immune response ten years after intradermal or subcutaneous yellow fever vaccination

To investigate the long term (ten years) protective immune response to fractional yellow fever vaccination (1/5th of the standard dose, injected intradermally), compared to the standard subcutaneous vaccination

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…

Prospective assessment of mumps virus transmission

Main objective: To quantify mumps transmission parameters in exposed individuals, comparing symptomatic and asymptomatic cases, to understand and model ongoing transmission; Secondary: to assess cellular immuunresponses in mumps exposed infected and…

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…

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…

Immunity after yellow fever vaccination in HIV positive travelers - YELLAR study

Primary Objective: To determine the height and duration of viremia, the seroconversion rate and the level of neutralising antibodies in relation to - the actual number of CD4 positive cells- the nadir of CD4 positive cells- the duration of CD4 count…

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…

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 study of more time-efficient and cost-effective pre-exposure rabies vaccination schedules to secure timely adequate protection prior to military deployment

1. To reduce the time required for pre-exposure rabies vaccination of military personnel2. To reduce costs of pre-exposure rabies vaccination of military personnel 3. To obtain a non-inferior immune response to a shortened, low-dosed scheme compared…

A multi-center, prospective, blinded validation study to assess the accuracy of a host-response based diagnostics for distinguishing between bacterIal and viral etiology in pediatric patients with lower respiratory tract infections and fever without source

To externally validate the accuracy of a host-response based diagnostics for differentiating between bacterial and viral etiology in pediatric patients aged 2 to 60 months with LRTI or FWS.

A Phase 3, Open Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically Suppressed, HIV 1 Positive Subjects

The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, and GT6 Infection

Primary Objective(s) & HypothesisObjective: 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…

Bioequivalence of Crushed Stribild with a normal breakfast or with drip feed compared to the whole tablet.

Primary objective:To assess the bioequivalence of single dose STB after administration of standardized breakfast followed by a whole tablet (reference) and a crushed and suspended tablet (intervention I).To assess the bioequivalence of single dose…