NCT05648201

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 hiv

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
12 months until next milestone

Results Posted

Study results publicly available

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

December 5, 2022

Results QC Date

December 31, 2025

Last Update Submit

March 31, 2026

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

  • M:P Ratio

    Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio

    24hours after ingestion of study drug

Secondary Outcomes (6)

  • AUCtau

    24hours after ingestion of study drug

  • Cmax

    Within 24 hours after ingestion of study drug

  • Ctrough

    24hours after ingestion of study drug

  • Clearance of Study Drugs

    24hours after ingestion of study drug

  • Apparent Volume of Distribution

    24hours after ingestion of study drug

  • +1 more secondary outcomes

Other Outcomes (1)

  • Infant Dose

    24hours after ingestion of study drug

Study Arms (2)

Doravirine

EXPERIMENTAL

1 single dose of 100mg doravirine taken orally

Drug: Doravirine 100Mg Tab

Biktarvy

EXPERIMENTAL

1 single dose of 25/200/50mg taken orally

Drug: Biktarvy 50/200/25 Tab

Interventions

Doravirine 100Mg TabDRUG

1 single dose of 100mg taken orally

Also known as: pifeltro
Doravirine
Biktarvy 50/200/25 TabDRUG

1 single dose of 50/200/25 taken orally

Also known as: biktarvy
Biktarvy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubject has to be able to produce breastmilk
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

doravirinebictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
L.C. van der Wekken-Pas
Organization
Radboudumc
wendy.vanderwekken-pas@radboudumc.nl
0031681485606

Study Officials

  • Angela Colbers, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 13, 2022

Study Start

March 1, 2023

Primary Completion

November 1, 2024

Study Completion

April 28, 2025

Last Updated

April 16, 2026

Results First Posted

April 16, 2026

Record last verified: 2025-09

Locations

NL(1)