Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

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.

Timeline

Start

2023-03-01

Primary completion

2024-11-01

Completion

2025-04-28

Drugs

Indications