Status:
COMPLETED
Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana
Lead Sponsor:
Duke University
Collaborating Sponsors:
The Emmes Company, LLC
Conditions:
Lactating Women on Select DOI
Breastmilk Fed Infants of Mothers on Select DOI
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this study is to characterize the pharmacokinetics (PK) of understudied drugs administered to lactating women, receiving antiretroviral drugs per SOC as prescribed by their healthcare p...
Detailed Description
Prospective, single-site, open label, PK and safety study. Co-enrollment of lactating women ≥18 years of age receiving drugs of interest (DOIs) per standard of care (SOC), as prescribed by their healt...
Eligibility Criteria
Inclusion
- Inclusion Criteria Mothers/Infants:
- 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
- Exclusion Criteria Mothers/Infants:
- 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.
- Known pregnancy of mother during sample collection.
- 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.
Exclusion
Key Trial Info
Start Date :
January 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2025
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04862975
Start Date
January 9 2024
End Date
January 30 2025
Last Update
February 6 2025
Active Locations (4)
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1
Botswana-UPenn Partnership
Botswana, Gaborone, South Africa
2
Lesirane Clinic
Botswana, Gaborone, South Africa
3
Mogoditshane Clinic KDC
Botswana, Gaborone, South Africa
4
Old Naledi Clinic
Botswana, Gaborone, South Africa