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

Completed

• Conditions: Lactating Women on Select DOI; Breastmilk Fed Infants of Mothers on Select DOI; HIV Infections
• Interventions: Drug: Dolutegravir; Drug: Lamivudine; Drug: Emtricitabine; Drug: Tenofovir Disoproxil Fumarate

• Registration Number: NCT04862975
• Lead Sponsor: Duke University

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 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.

Study Timeline

• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-28
• Study Start: 2024-01-09
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug of Interest	Dolutegravir	Lactating moms receiving one or more antiretroviral drugs and their breastmilk fed infants per standard of care.
Drug of Interest	Lamivudine	Lactating moms receiving one or more antiretroviral drugs and their breastmilk fed infants per standard of care.
Drug of Interest	Emtricitabine	Lactating moms receiving one or more antiretroviral drugs and their breastmilk fed infants per standard of care.
Drug of Interest	Tenofovir Disoproxil Fumarate	Lactating moms receiving one or more antiretroviral drugs and their breastmilk fed infants per standard of care.

Primary Outcome Measures

Name	Time	Method
Drug concentration in infant plasma	Baseline	Drug concentration of a DOI in infant plasma
Estimated daily infant dose	Baseline	The drug exposure of selected DOIs will be evaluated using the estimated daily infant dose
Drug concentration in maternal plasma	Baseline	Drug concentration of a DOI in maternal plasma
Drug concentration in maternal breastmilk	Baseline	Drug concentration of a DOI in maternal breastmilk
Milk/Plasma ratio	Baseline	The drug exposure of selected DOIs will be evaluated using milk/plasma ratio
Relative infant dose	Baseline	The drug exposure of selected DOIs will be evaluated using relative infant dose
Infant/maternal exposure ratio	Baseline	The drug exposure of selected DOIs will be evaluated using infant/maternal exposure ratio

Trial Locations

Locations (4)

Botswana-UPenn Partnership; 🇿🇦 Botswana, Gaborone, South Africa

Lesirane Clinic; 🇿🇦 Botswana, Gaborone, South Africa

Mogoditshane Clinic KDC; 🇿🇦 Botswana, Gaborone, South Africa

Old Naledi Clinic; 🇿🇦 Botswana, Gaborone, South Africa