Phase 4 N=20 Treatment

Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

Hiv

Bottom Line

View on ClinicalTrials.gov: NCT05648201 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: M:P Ratio — 0.26; 0.0085 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Doravirine 100Mg Tab (Drug); Biktarvy 50/200/25 Tab (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Radboud University Medical Center
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY M:P Ratio	0.26; 0.0085	—
SECONDARY AUCtau	—	—
SECONDARY Cmax	—	—
SECONDARY Ctrough	—	—
SECONDARY Clearance of Study Drugs	—	—
SECONDARY Apparent Volume of Distribution	—	—
SECONDARY Half Life	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05648201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.