Clinical trials: sponsored by Radboud University Medical Center
HIV Infections
Pharmacokinetic Study of Two Generic Co-formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)
This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded formulation.
- Trial name
- SURF (NCT00665951)
- Testing
- Lopinavir/ritonavir
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV Infection, HIV Infections
Pharmacokinetic and Safety Study of Raltegravir and Atazanavir in a Once Daily Dose Regimen in HIV-1 Infected Patients
The licensed dose of raltegravir is 400 mg twice daily with or without food. Raltegravir is metabolized predominantly through glucuronidation by UGT1A1.
- Trial name
- PRADA (NCT00943540)
- Testing
- raltegravir QD, atazanavir, lamivudine (or emtricitabine)
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
HIV Infection, Fungal Infection
Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir
The purpose of this study is to determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is to determine the safety of combined use of…
- Trial name
- EPOS (NCT00817765)
- Testing
- Posaconazole, Fosamprenavir, Ritonavir
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV Infections, Hyperlipidemia
Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
- Trial name
- NCT00184951
- Testing
- Rosuvastatin
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Neoplasms, Chronic Myeloid Leukemia
Effects of a Digital Patient Platform (CMyLife) for Patients With Chronic Myeloid Leukemia (CML) on Information Provision, Patient Empowerment, Medication Compliance, Guideline Adherence and Quality of Life
A controlled before-after study is performed in order to gain insights into the effectiveness of the CMyLife platform in terms of medication compliance, guideline adherence, quality of life, information provision and patient…
- Conditions
- Neoplasms, Chronic Myeloid Leukemia, Patient Portals, Telemedicine
- Trial name
- NCT04595955
- Testing
- CMyLife
- Where
- Netherlands
- Volunteers
- 99 people
- Sponsor
- Radboud University Medical Center
Peritoneal Carcinomatosis
Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy
Currently, there is a lack of knowledge on the effect of additional flushing after HIPEC on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure.
- Trial name
- GUTOX (NCT03364907)
- Testing
- HIPEC with flushing afterwards, HIPEC without flushing afterwards
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
HIV, Hypercholesterolaemia
Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.
Dyslipidemia is highly prevalent among patients with HIV infection and contributes to the increased cardiovascular disease risk in this patient population.
- Trial name
- AVIATOR (NCT01779687)
- Testing
- raltegravir, Atorvastatin
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV Infections
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.
- Trial name
- GRAPPA (NCT00665717)
- Testing
- Pravastatin, Raltegravir, Pravastatin and raltegravir
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV Infections
The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women.
Pharmacokinetic study of Saquinavir and Ritonavir in HIV-infected pregnant women
- Trial name
- NCT00145561
- Testing
- Saquinavir and Ritonavir
- Where
- 10 sites in Germany, Netherlands and 3 more
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
HIV, Depression
Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL).
Depression is the most common mental health disorder among HIV-patients. Recognizing and treating depression is important in order to improve quality of life and health outcomes in those living with HIV.
- Trial name
- RECITAL (NCT01978782)
- Testing
- raltegravir, citalopram
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Morbid Obesity
Micafungin Pharmacokinetics in Obese Patients
Because micafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections.
- Trial name
- MICADO (NCT03102658)
- Testing
- Micafungin
- Where
- 2 sites in Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Morbid Obesity
Dosing Obese With Noxafil® Under a Trial (DONUT)
Although posaconazole is approved for the prophylaxes and treatment of invasive fungal infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not specified.
- Trial name
- DONUT (NCT03246386)
- Testing
- Posaconazole Injection [Noxafil] 300mg, Posaconazole Injection [Noxafil] 400mg
- Where
- 2 sites in Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Metastatic Castration Resistant Prostate Cancer
Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected miRNAS can be used to personalize enzalutamide therapy.
- Trial name
- ILUMINATE (NCT02471469)
- Testing
- Enzalutamide, 160mg, 40 mg soft capsules, once daily
- Where
- 3 sites in Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Cancer
Pazopanib Tolerability When Given With Food
Pazopanib (Votrient) is registered for the treatment of patients with advanced renal cell carcinoma and patients with soft tissue sarcoma who have received prior chemotherapy.
- Trial name
- DIET (NCT02138526)
- Testing
- pazopanib, continental breakfast
- Where
- Netherlands
- Volunteers
- 78 people
- Sponsor
- Radboud University Medical Center
Hepatitis C, Swallowing Disorder
Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.
Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor…
- Trial name
- COPA (NCT03513393)
- Testing
- velpatasvir
- Where
- Netherlands
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Hepatitis C, Deglutition Disorders
Bioequivalence Study of Crushed Elbasvir/Grazoprevir Compared to the Whole Tablet
Elbasvir/grazoprevir (Zepatier®) is a once-daily tablet for the treatment of chronic hepatitis C virus (HCV) GT1a, 1b or 4 infection containing the NS5A inhibitor elbasvir (ELB) 50 mg and the NS3/4A protease inhibitor grazoprevir…
- Trial name
- CRUSADE-2 (NCT03817619)
- Testing
- Zepatier whole tablet, Zepatier crushed tablet
- Where
- Netherlands
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Bacterial Infections
Pharmacokinetics of Ciprofloxacin in Critically Ill Patients
Optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking resulting in large variation of achieved exposure and possible inadequate therapy.
- Trial name
- CAPOEIRA (NCT03016845)
- Where
- 4 sites in Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Morbid Obesity
Liposomal Amphotericin B (AmBisome) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ASPEN)
Dosing guidelines for liposomal amphotericin B (AmBisome) in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of AmBisome in this specific patient population is still largely unknown.
- Trial name
- NCT02320604
- Testing
- Administration of study drug
- Where
- 2 sites in Netherlands
- Volunteers
- 16 people
- Sponsor
- Radboud University Medical Center
HIV Infection
Pharmacokinetic Study on Raltegravir and Lamotrigine
The purpose of this study is to determine whether interactions between raltegravir and lamotrigine take place and to study the safety of the combination raltegravir/lamotrigine before used in HIV patients.
- Trial name
- GRANOLA (NCT00618241)
- Testing
- lamotrigine, Raltegravir
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Infectious and Communicable Diseases
Compliance With Hand Hygiene in Nursing Homes: Go for a Sustainable Effect (CHANGE)
Hand hygiene (HH) appears to be a simple, non-complex procedure to prevent healthcare-associated infections (HAIs), implementation in daily routine is difficult.
- Trial name
- CHANGE (NCT02817282)
- Testing
- Hand hygiene implementation strategy
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center