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

CompletedN/A

Sponsor: Radboud University Medical Center

Conditions: HIV-1-infection

Interventions: Therapeutic drug monitoring in plasma of mother and child and in breastmilk

Countries: Netherlands

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Nijmegen, Gelderland, Netherlands
Amsterdam, North Holland, Netherlands
Rotterdam, South Holland, Netherlands