Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how certain HIV medications, called antiretrovirals, pass into breast milk after a mother takes a single dose. The medications being tested are doravirine, raltegravir, and a combination of tenofovir alafenamide, emtricitabine, and bictegravir. Understanding how these drugs are present in breast milk is important because if the concentration is too high, it could harm the breastfeeding infant, but if it’s too low, it may not protect the child if they were to get infected with HIV.

To participate in this study, women must be at least 18 years old, healthy, and finished breastfeeding, but still able to produce milk. They should have given birth at least 10 days before the study starts and must be willing to sign consent forms. Participants will receive a single dose of one of the medications and will have their milk and blood tested to see how much of the drug is present. This study is currently recruiting participants, and it's a great opportunity to help improve our understanding of how these vital medications can affect breastfeeding mothers and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • At least 18 years of age at the moment of screening
• • At least 10 days post partum
• • At the end of breastfeeding period; subject is able to produce breastmilk at least two times a day and is no longer feeding infant at start of study
• • Able and willing to sign an informed consent
• Exclusion Criteria:
• • Relevant co-medication or comorbidity that might interfere with drug absorption, distribution, metabolism or excretion
• • Inability to take drugs according to the instructions (i.e. with food)
• • Presence of positive HIV screening or HIV RNA
• • Presence of HBsAg or HBcAg without anti-HBs
• • Presence of grade III/IV anaemia (i.e. Hb \<4.6 mmol/L or \<7.4 g/dL).
• • Presence of hereditary forms of severe galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

Trial Officials