Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed (PANNA-B TDM)

Radboud University Medical Center

Status: Completed

Conditions: HIV-1-infection

Treatments: Diagnostic Test: Therapeutic drug monitoring in plasma of mother and child and in breastmilk

Study type: Observational

Funder types: Other

Identifiers

NCT05642481

PANNA-B TDM

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

16 participants in 1 patient group

Antiretroviral drugs with marketing authorisation in Europe

Description:

This study includes subjects who already take antiretroviral drugs to treat HIV-1 with a marketing authorisation in Europe. These drugs already have a marketing authorisation and are prescribed by the treating physician of the subject. No adjustments to their treating regimen are made in order to participate in this study. All antiretrovirals with a marketing authorisation in Europe are eligible for inclusion in this study, but most subjects are expected to use a backbone of nucleoside reverse transcriptase inhibitors combined with either dolutegravir, raltegravir, darunavir or rilpivirine

Treatment:

Diagnostic Test: Therapeutic drug monitoring in plasma of mother and child and in breastmilk