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The applicability of rapid serological and molecular testing for Corona SARS-2 in a Dutch population during the COVID-19 outbreak.

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SARS-CoV-2 vaccination response in people living with HIV

Main study: primary vaccination regimenPrimary Objective: 1. To determine the difference in the antibody response against SARS-CoV-2 in PLWH 4 weeks after the completed vaccination schedule with one of the two available mRNA vaccines (BNT162b2 or…

The TRISTARDS trial - ThRombolysIS Therapy for ARDS
A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19.

Main objective is to evaluate the efficacy and safety of two (Part 1) different dosing regimen and of one dosing regimen (Part 2) of intravenous alteplase given for up to 5 days on top of standard of care (SOC) compared with SOC alone in ARDS…

TURN-COVID Biobank:
The Dutch cohort study for the evaluation of the use of neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2

This study has been transitioned to CTIS with ID 2024-515263-60-00 check the CTIS register for the current data. - A. What are the SARS-CoV-2 viral load kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral…

Five-year boostability after single-visit single-dose intramuscular rabies pre-exposure prophylaxis.

The aim of this study is to demonstrate that a single dose of rabies vaccine can induce an equally rapid and adequate anamnestic antibody response as 2-dose PrEP to revaccination five years later.

Establishing immunogenicity and safety of needle-free intradermal delivery by nanoporous ceramic skin patch of mRNA SARS-CoV-2 vaccine as a revaccination strategy in healthy volunteers

Primary objective - to describe immunogenicity and safety in healthy volunteers of the intradermal dermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with…

Relative bioavailability study to investigate a potential interaction between dolutegravir (DTG) and tenofovir alafenamide fumarate/emtricitabine (F/TAF) administered as paediatric tablet formulations.

Primary objectives:- To assess the relative bioavailability of TAF and TFV after a single-dose FTC/TAF 3x60/7.5 mg DT (reference TAF) compared to TAF and TFV after a single-dose FTC/TAF 3x 60/7.5mg DT in combination with a single dose of DTG 30mg as…

A PHASE II, RANDOMISED, ADAPTIVE, OPEN-LABEL
PLATFORM TRIAL TO EVALUATE EFFICACY AND
SAFETY OF MULTIPLE COMBINATION THERAPIES IN
PARTICIPANTS WITH CHRONIC HEPATITIS B

Primary* To estimate the effect of NME combination therapies on inducing a functional cure over the control arm.Secondary * To characterize the efficacy profile of NME combination therapies.* To characterize the PD profile of NME combination…

Establishing the safety, tolerability and immunogenicity of intradermal delivery of mRNA SARS-CoV-2 vaccine in healthy adults

Primary objectives:- to describe tolerability, safety and immunogenicity in healthy adults of the intradermal delivery of one or two fractional doses of 10 µg and 20 µg mRNA-1273 LPN vaccine (Moderna).- to compare the immunogenicity in healthy…

LRAs United as a Novel Anti-HIV strategy (LUNA): a randomized controlled trial.

The longitudinal assessment of the BAFi pyrimethamine and of the HDACi valproic acid on the HIV reservoir size in HIV patients on antiretroviral therapy.

The role of pregnancy on susceptibility and antibody dependent enhancement of immune cells for Zika virus infection

The aim of this study is to determine whether white blood cells from pregnant women are more susceptible to infection with the Zika virus compared to white blood cells from non-pregnant women. We do this by collecting two tubes of blood from…

A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallelgroup, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alfenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed

Primary:To demonstrate the non-inferior antiviral activity of CAB LA + RPV LA every two months compared to a BIK single tablet regimen administered once daily over 12 months in suppressed HIV-1 infected antiretroviral therapy (ART)-experienced…

Serologic surveillance of SARS-CoV-2 during the 2020 pandemic in exposed and unexposed healthcare workers in an academic hospital in Amsterdam

1. to monitor how seroconversion rates of SARS-coV progress during the COVID-19 pandemic in health care workers with direct contact with COVID-19 suspected or confirmed patients compared to a control group without this exposure, and 2. assess the…

A Phase 2, Comparative Randomised Trial to Evaluate the impact of reduced COVID-19 mRNA vaccination regimen on immunological responses and reactogenicity in paediatric subjects with prior SARS-CoV-2 immunity

Primary ObjectiveTo determine if the humoral immune response of a single compared to a two dose COVID-19 vaccination regimen is non-inferior in paediatric subjects who are immunologically primed by natural infection. Secondary Objective(s) 1.To…

Role of host cell DNA methylation analysis in predicting non-regression or regression of high-grade anal intraepithelial neoplasia in HIV+ men trial (MARINE)

In this study we clinically validate if host cell DNA methylation markers can predict (non-)regression of HGAIN, thus determining the need of immediate treatment versus active surveillance and the safety of withholding treatment. This could prevent…

Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)

This study has been transitioned to CTIS with ID 2024-515487-31-00 check the CTIS register for the current data. The primary objective of this study is to describe the pharmacokinetics of antiretroviral agents, for which no or limited available…

Identifying mucosal defence mechanisms against viral infections in patients with COPD and consequences for the development of exacerbations

We aim to characterize innate anti-viral defence responses in the upper airways of COPD patients.

Immunity against SARS-CoV-2 in immune-suppressed patients: increased risk of insufficient
immunological memory or sufficient protection against re-infection? A Target to B! substudy

- To compare the course and determinants of the SARS-CoV-2-specific humoral and cellular immune response in AID patients upon primary SARS-CoV-2 infection to that in healthy controls (HC)- To determine the seroconversion rate, magnitude and…

Detecting the antigen-specific B-cell-response to rabies vaccination.

The goal of this study is to develop a flow-cytometric assay that is able detect antigen-specific B-cells to rabies vaccine.

Biomarker-based Early Anti-inflammatory Therapy for severe COVID-19

Identifying the pro-inflammatory biomarker profile in the pathophysiology of acute sever lung disease in SARS-CoV-2 infection, and using this profile to identify the patients who are at risk of developing acute severe lung disease and multi-organ…