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Markers for neurocognitive impairment in congenitally CMV infected infants: MARVELYS study

1. To characterize long-term neurologic- and cognitive disorders, audiological and ophthalmological alterations in cCMV-infected children.2. To identify immunological, neurological host factors and virological factors that are predictive of…

Biomarkers of the HIV reservoir

Primary objectivesLongitudinal quantification of the total latent HIV reservoir with determination of the size of the replication competent HIV reservoir and investigate potential biomarkers of the HIV reservoir size and nature.Cross compare the…

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…

A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

The primary objective of this Registry is:• To evaluate HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral containing regimen…

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…

Quality of life viral and Immunological dynamics in patients with effectively suppressed HIV who switch second or furtherline cART to a Once daily High genetic barrier Antiretroviral regimen of boosted darunavir and dolutegravir

The primary objective is to investigate quality of life after switch to a combination therapy including boosted DRV and DTG. Secondary objectives are to investigate 1) the residual viral replication, 2) level of virus production from infected cells…

Monitoring the intrahepatic immune responses in chronic HBV patients after long-term treatment with tenofovir

Study of the phenotype and function of NK cells obtained from peripheral blood and liver of patients who are successfully being treated for at least 3-4 years for their chronic HBV infection with tenofovir in a flow-up study (METC nr. 2008-271).

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-…

Investigation of the effects of switching to a high genetic barrier protease inhibitor based regimen on low level viremia, immune activation and neurocognitive performance in patients on antiviral therapy

Primary: to investigate the most importants determinants of the viral dynamics of low-level viremia. Secondary: to investigate the effects on immune activation, neurocognitive performance and periodontal status.

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…

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.

Palatability testing of a new paediatric formulation of valacyclovir for the prophylaxis and treatment of VZV and HSV infections in children - VALID 0

PrimaryTo determine whether the palatability of a newly developed formulation of valacyclovir is non-inferior to administration of crushed and suspended tablets in children, is the primary objective of the second phase of the trial.The primary…

A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection

The primary objective of this Registry is:*To evaluate the long term effects of Hepatitis B Virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144 The secondary objective of this Registry is :*To evaluate the long…

Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years

This study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer…

Evaluation of measuring viral loads in self-sampled dried blood spots

The objectives of this study are: 1) To assess the user friendliness of the DBS self-sampling technique.2) To assess the quality of ssDBS.3) To estimate the agreement between viral loads in ssDBS and laboratory spotted DBS (labDBS).

Immunity to varicella-zoster virus in patients before and after lung transplantation

Objective of the study is to evaluate efficacy of VZV vaccination in lung transplantation patients, intended to prevent morbidity by VZV infection. Efficacy of vaccination will be measured by means of determining cellular immunity to VZV. Cellular…

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

The effect of cold exposure on influenza induced immune responses

determine the effect of cold exposure on influenza induced immune responses

Identification and characterization of the latent HIV-infected reservoir in long-term anti-retroviral therapy (ART) suppressed patients

To identify and quantify the HIV reservoir in T-cell subsets of patients who have been on ART for almost 20 years.