Clinical trials: sponsored by Radboud University Medical Center
Human Immunodeficiency Virus, Children
Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children
Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination antiretroviral therapy for treatment of HIV-infected adults according to international guidelines.
- Trial name
- DAPHNE (NCT02285478)
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Radboud University Medical Center
Prostate Cancer
Improving Bio-availability of the Expensive Oral Oncolytic Drug Abiraterone by Food Intake
Abiraterone is a selective inhibitor of androgen biosynthesis that potently and irreversibly blocks CYP17, a crucial enzyme in testosterone and estrogen synthesis.
- Trial name
- SNACK (NCT02883166)
- Testing
- abiraterone
- Where
- Netherlands
- Volunteers
- 14 people
- Sponsor
- Radboud University Medical Center
Varicella Zoster Virus Infection, Herpes Simplex Virus Infection
Palatability Testing of a New Paediatric Formulation of Valacyclovir
Palatability testing of a new paediatric formulation of valacyclovir in children 4-12 years of age and at least one of their parents.
- Trial name
- VALID-0 (NCT01682109)
- Testing
- Valacyclovir
- Where
- Netherlands
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Candidiasis
Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients
The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine fluconazole and free fluconazole concentrations in 20 ICU patients, who will get…
- Trial name
- PACIFIC (NCT02666716)
- Testing
- fluconazole
- Where
- 3 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
Invasive Fungal Infection
Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates
The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU patients, who will get caspofungin as standard…
- Trial name
- CASCADE (NCT01533558)
- Testing
- caspofungin
- Where
- 4 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
HIV Infections, HCV Infections
Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir
The objective of this study is to evaluate the effect of boceprevir (steady state) on the pharmacokinetics of a single dose of raltegravir.
- Trial name
- OPAL (NCT01288417)
- Testing
- boceprevir, raltegravir
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV-infection, Pregnancy
The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance
The primary objective of this two-phase trial is as follows: To determine the elimination half-life of NVP in HIV positive pregnant women receiving it as a single dose in labour in addition to the ZDV and 3TC with or without…
- Conditions
- HIV-infection, Pregnancy, Mother to Child Transmission
- Trial name
- VITA 2 (NCT01187719)
- Testing
- phenytoin
- Where
- 2 sites in Tanzania, Zambia
- Volunteers
- 66 people
- Sponsor
- Radboud University Medical Center
HCV Infections, Gastric Acid-related Disorders
Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO)
The objective of this study is to determine the effect of multiple dose omeprazole on the pharmacokinetics of boceprevir and vice versa.
- Trial name
- PROMO (NCT01470690)
- Testing
- boceprevir, Omeprazole
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Breast Cancer
PharmacoKINEtics of TAMoxifen and Its Metabolites in Breast Cancer Patients: the Influence of a Dose Increase in Phenotypic Poor Metabolizers of CYP2D6 (KINETAM)
All women on tamoxifen receive the standard dose of 20mg QD, irrespective of the use of potential CYP2D6 inhibitors, and are not tested for CYP2D6 polymorphisms prior to start of tamoxifen treatment.However CYP2D6 polymorphisms…
- Trial name
- KINETAM (NCT01192308)
- Testing
- Tamoxifen 40mg QD
- Where
- Netherlands
- Volunteers
- 42 people
- Sponsor
- Radboud University Medical Center
Obesity Morbid
Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT)
Because anidulafungin 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
- ADOPT (NCT02021123)
- Testing
- Anidulafungin 100mg single dose iv
- Where
- 2 sites in Netherlands
- Volunteers
- 8 people
- Sponsor
- Radboud University Medical Center
Chronic Granulomatous Disease
Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)
The purpose of this study is to find a dose for a twice daily regimen for posaconazole (PSZ) as prophylactic treatment in children with CGD, based on the PSZ trough level.
- Trial name
- iPOD (NCT00799071)
- Testing
- posaconazole (PSZ)
- Where
- 2 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- Radboud University Medical Center
HIV Infections
Pharmacokinetics Study on Nevirapine Resistance in Tanzania
Primary pharmacokinetics of single dose nevirapine the effect of single dose carbamazepine on the pk of single dose nevirapine resistance against nevirapine before and after.
- Trial name
- NCT00294892
- Testing
- carbamazepine and nevirapine, Nevirapine
- Where
- Tanzania
- Volunteers
- 144 people
- Sponsor
- Radboud University Medical Center
Tumor
Pharmacokinetic Study on the Addition of Aprepitant to Cisplatin - Etoposide Treatment in Lung Cancer Patients
The purpose of this study is to determine whether aprepitant can be used in the Cisplatin - Etoposide chemotherapeutic regimen.
- Trial name
- ACE (NCT00588835)
- Testing
- aprepitant, Dexamethasone and Ondansetron during CE-treatment
- Where
- 2 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
HIV Infections
Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA)
The effect of fosamprenavir/ritonavir (steady state) on the pharmacokinetics of a single dose of olanzapine will be studied. In this study, the investigators expect an inducible effect of fosamprenavir/ritonavir on the CYP1A2 and…
- Trial name
- FORZA (NCT00977301)
- Testing
- fosamprenavir/ritonavir, olanzapine
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV Infections, Depression
The Influence of GINkGo Biloba on the Pharmacokinetics of the UGT Substrate raltEgraviR (GINGER)
The objective of this study is to evaluate the effect of ginkgo biloba (steady state) on the pharmacokinetics of a single dose of the UGT-substrate raltegravir. Furthermore the safety profile of the combination is studied.
- Conditions
- HIV Infections, Depression, Mild Cognitive Impairment
- Trial name
- GINGER (NCT01246804)
- Testing
- raltegravir single dose, ginkgo biloba multiple dose
- Where
- Netherlands
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Invasive Fungal Infection
Pharmacokinetics of Micafungin in Patients Intensive Care Unit
In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected cohort of patients with suspected or proven invasive fungal infections.
- Trial name
- MIMIC (NCT01783379)
- Testing
- micafungin
- Where
- 4 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
Depressive Disorder, Major
Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or…
- Trial name
- NCT00928980
- Testing
- Mindfulness Based Cognitive Therapy, Optimal Medical Care
- Where
- 13 sites in Netherlands
- Volunteers
- 317 people
- Sponsor
- Radboud University Medical Center
Tuberculosis
Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia
Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.
- Trial name
- NCT00306319
- Testing
- moxifloxacin
- Where
- Indonesia
- Volunteers
- 23 people
- Sponsor
- Radboud University Medical Center
Delirium
pRophylactic halopEriDol Use for Delirium in iCu patiEnts With a High Risk for Delirium
The aim of this study is to determine the effects of a low dosage of prophylactic haloperidol in patients with a high risk to develop delirium, defined by an expected ICU length of stay of >1 day.
- Trial name
- REDUCE (NCT01785290)
- Testing
- Haloperidol 1 mg/q8h, Haloperidol 2 mg/q8h
- Where
- Netherlands
- Volunteers
- 1,800 people
- Sponsor
- Radboud University Medical Center
HIV Infections, Malaria
Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately, there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by induction of atovaquone metabolism.
- Trial name
- NCT00421473
- Testing
- Atovaquone / Proguanil
- Where
- 5 sites in Netherlands
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center