NCT05648201CompletedPhase 4
Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 5 Dec 2022
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Nov 2024
- Lead sponsor
- Radboud University Medical Center
- Diseases
- HIV
- NCT number
- NCT05648201
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 20
- From 1 Mar 2023 to the primary completion date, 1 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Presence of positive HIV screening or HIV RNA
Lab values
- 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
Other
- Presence of HBsAg or HBcAg without anti-HBs
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.