NCT05642481

Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, longitudinal, mother-infant pair, therapeutic drug monitoring study. The aim of this study is to determine concentrations of antiretroviral drugs in plasma and breastmilk in people living with HIV who chose to breastfeed while using antiretrovirals. At a planned hospital visit an extra maternal blood sample (1 to 2 per visit) and extra infant blood sample (1 per visit) will be collected, as well as a breastmilk sample (1 to 2 per visit). Ideally, sample collection will take place at least during the 1, 3 and 6 month post partum follow up visit. Measured concentrations will be used to calculate milk to plasma ratios, relative and absolute infant dosages.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Therapeutic drug monitoring in plasma of mother and child and in breastmilk	Measurement of drug concentration in plasma of mother and if possible of child and in breastmilk

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-12-08
• Last updated: 2025-12-09

Locations

3 sites across 1 country: Netherlands