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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how certain medications for HIV, known as antiretrovirals, are transferred from mothers to their breastmilk while they breastfeed. The study aims to understand how much of these drugs is in the mother's blood and in her breastmilk, which is important for ensuring the safety and health of both mothers and their infants. By collecting blood samples from both the mother and the infant, as well as breastmilk samples at various check-ups after giving birth, researchers can find out how much medication the baby might be receiving through breastfeeding.

To participate in this study, women must be at least 18 years old, have a confirmed HIV infection, and be breastfeeding an infant. They also need to have been taking certain approved HIV medications for at least two weeks before joining the trial. There are no specific exclusion criteria for this trial, which means that if you meet the inclusion criteria, you could be eligible to participate. Participants can expect to provide additional blood and breastmilk samples during scheduled visits, helping researchers gather important information that could improve treatment for mothers living with HIV and their babies.

Gender

FEMALE

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.