NCT04862975

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 164 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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 provider, and their co-enrolled infants ≤180 days of age who receive maternal breastmilk.

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 healthcare providers, and their infants who receive maternal breastmilk ≤180 days postpartum. To understand drug transfer into breastmilk and determine subsequent infant exposure, biological samples will be collected from lactating women (blood and breastmilk) and infants (blood). The opportunistic design of this study will allow for a minimal risk study, an expanded enrollment net, evaluation of antiretroviral drugs, and capitalization of procedures performed per SOC to maximize study efficiency and data collection and minimize potential risk to participants. The data collected through this initiative will provide valuable PK, dosing, and safety information for drugs in this vulnerable population in order to inform public health.

Conditions

• Lactating Women on Select DOI
• Breastmilk Fed Infants of Mothers on Select DOI
• HIV Infections

Interventions

Type	Name	Description
DRUG	Dolutegravir	Dolutegravir will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
DRUG	Lamivudine	Lamivudine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
DRUG	Emtricitabine	Emtricitabine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
DRUG	Tenofovir Disoproxil Fumarate	Tenofovir Disoproxil Fumarate will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.

Timeline

• Start date: 2024-01-09
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2021-04-28
• Last updated: 2025-02-06

Locations

4 sites across 1 country: South Africa