Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Nov 29, 2022
Trial Information
Current as of January 14, 2025
Unknown status
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.
About Radboud University Medical Center
Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nijmegen, Gelderland, Netherlands
Amsterdam, Noord Holland, Netherlands
Rotterdam, Zuid Holland, Netherlands
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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