Merck BF Study

STUDY BASICS

Are you breastfeeding and ready to completely wean your baby from breastmilk? If you are age 18-45 and HIV negative, you may be eligible to help to advance HIV prevention research. Women in this study take 1 dose of an investigational drug and then researchers measure how much of the medication gets into their blood and breastmilk.

STUDY PURPOSE

The purpose of this study is to understand how much of an investigational drug used to prevent HIV gets into breastmilk and blood of healthy, HIV negative women. 

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants are:

• Women at least 18 years old
• HIV negative and healthy
• Lactating women ready to permanently wean their babies from breastmilk

WHAT PARTICIPANTS CAN EXPECT

Participants must be ready to wean and permanently stop feeding their baby breastmilk. They must also be willing to attend approximately 11 in-person study visits and keep their milk supply up to 3 weeks by pumping their breastmilk.   

Each woman will attend a screening visit to learn more about the study and to assess their overall health and ability to complete the study. The screening visit will include bloodwork, urine tests, drug testing, and heart rhythm tracings (EKG).  

Women who enroll in the study take one dose of the study drug and remain at Magee in the research center for the day (approximately 9-10 hours) to monitor levels of the study drug in their blood and breastmilk. They will receive instructions on home breastmilk collection.  

They return to the research center each morning for the next week, then at 14 and 21 days if still producing milk. Blood and breastmilk are collected to monitor the study drug levels. Participants also complete a phone call that takes place 42 days (6 weeks) after taking the study drug.