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

Radboud University Medical Center16 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV-1-infection

Interventions

Therapeutic drug monitoring in plasma of mother and child and in breastmilkDIAGNOSTIC_TEST

Measurement of drug concentration in plasma of mother and if possible of child and in breastmilk

Medical Language ↔ Plain English

Inclusion criteria * Patients of at least 18 years of age at the moment of screening * Patients with HIV-1 as documented with positive HIV antibody test, HIV RNA of antigen test * Patients breastfeeding their infant * Patients using antiretrovirals for the treatment of HIV-1 with a marketing authorisation in Europe (table 1 in Appendix) * Patients using current antiretrovirals for a minimum of 2 weeks to assure drug concentrations are in steady state * Patients who are able and willing to sign an informed consent Exclusion Criteria: No exclusion criteria will be used at the screening for the trial.

Locations (3)

Radboudumc

Nijmegen, Gelderland, Netherlands

Amsterdamumc

Amsterdam, North Holland, Netherlands

Erasmusmc

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

Breastmilk to maternal plasma ratio

Total concentration of antiretrovirals in breastmilk and plasma of the mother at a single time point to determine milk to plasma ratio.