Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
No to little data exists on penetration of antiretroviral drugs in breastmilk. Too high
concentrations may lead to infant toxicity and too low concentrations may lead to development
of resistance in case the infant inadvertently becomes infected with the virus.
The aim of this trial is to determine the concentration of currently often used ARV
(doravirine, raltegravir, bictegravir, tenofovir alafenamide, emtricitabine) in breast milk
after administration of a single dose Study design: This is a single centre, single dose,
open label, pharmacokinetic study in healthy volunteers.
Study population: Adult, healthy volunteers at the end of their breastfeeding period
Intervention: Administration of one dose of either doravirine (DOR) 100mg, raltegravir (RAL)
1200mg or a combination of tenofovir alafenamide 25mg, emtricitabine 200mg and bictegravir
50mg (BIC/FTC/TAF).
Main study parameters/endpoints: Area under the plasma and milk concentration curve are used
to calculate milk to plasma ratio.
Phase:
Phase 4
Details
Lead Sponsor:
Radboud University Medical Center
Collaborators:
Merck Sharp & Dohme LLC ZonMw: The Netherlands Organisation for Health Research and Development