Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radboud University Medical Center
• Collaborators: Merck Sharp & Dohme LLC; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria:

• At least 18 years of age at the moment of screening

• At least 10 days post partum

• At the end of breastfeeding period; subject is able to produce breastmilk at least two times a day and is no longer feeding infant at start of study

• Able and willing to sign an informed consent

Exclusion Criteria:

• Relevant co-medication or comorbidity that might interfere with drug absorption, distribution, metabolism or excretion

• Inability to take drugs according to the instructions (i.e. with food)

• Presence of positive HIV screening or HIV RNA

• Presence of HBsAg or HBcAg without anti-HBs

• Presence of grade III/IV anaemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL).

• Presence of hereditary forms of severe galactose intolerance, total lactase deficiency or glucose-galactose malabsorption