Summary
The Pharmacokinetic and Safety of Antiretroviral and Related Drugs in Lactating Women and Breastmilk Fed Infants (BMS02) study will help answer important questions about breastfeeding for women living with HIV/AIDS around the world.
Botswana, like many other countries in Africa, was hit hard by the HIV/AIDs pandemic more than a decade ago. However, with its government’s leadership and commitment to providing free antiretroviral medications, the once devastating disease has become a chronic condition for many.
Today, over 20% of the adult population lives with HIV and 82% of those people take antiretroviral medications every day. But many women taking these medications who are also breastfeeding their infants have unanswered questions about safety. While studies indicate that the transmission of HIV from mother to child is reduced if the mother is on antiretroviral medications, there are not many studies that describe the extent of antiretroviral drug transfer into breastmilk.
Because of the prevalence of HIV in Botswana and its government’s commitment to treating the disease, many women are likely to be interested in helping to find answers to these important questions. The BMS02 study will specifically study the following drugs:
- Dolutegravir
- Emtricitabine
- Tenofovir disoproxil fumarate
- Lamivudine
A better understanding of the safety of common antiretroviral medications in breastfeeding infants will provide data to help clinical professionals everywhere to advise breastfeeding mothers who live with HIV/AIDs. Confirmed safety might promote breastfeeding and benefit both mothers and their children.
Mothers who participate in the study provide samples of breastmilk, their blood, their infants’ blood, or a combination to help researchers understand which drugs pass into breastmilk and determine the safest dose.
OVERVIEW
Status:
Enrolling
ClinicalTrials.gov identifier:
NCT04862975
Principal Investigator:
Angelique Boutzoukas, MD, MPH
Duke Health, Durham, NC
Co-Investigators:
Matthew Kelly, MD, MPH
Duke University Associate Professor of Pediatrics and Global Health
Duke Health, Durham, NC