Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

Prior treatment

• Any concomitant condition which, in the opinion of the participant's healthcare provider, the site principal investigator (PI), a research nurse, or designee conducting the study, would preclude participation in the study.
• Mother has pumped any breastmilk at all in between the last 6 direct infant feedings prior to sample collection.
• Infant was fed breastmilk in any manner besides nursing at mother's breast for any of the last 6 feedings prior to sample collection.
• Previous enrollment on this study.

Other

• Known pregnancy of mother during sample collection.

• Lactating women ≥18 years of age who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
• Informed consent, according to local IRB/REB/IEC guidelines, prior to any study-related procedures.
• If the mother is receiving more than one DOI, the mother must have taken all DOIs that she is receiving concomitantly for the 6 doses prior to sample collection.
• Mother participant is fluent in English or Setswana.
• Willing to provide at least 1 of the below required samples between the co-enrolled mother/infant pair:
  • Maternal breastmilk
  • Infant blood