Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana (BMS02)

Duke University

Status: Completed

Conditions: Breastmilk Fed Infants of Mothers on Select DOI; HIV Infections; Lactating Women on Select DOI

Treatments: Drug: Tenofovir Disoproxil Fumarate; Drug: Lamivudine; Drug: Emtricitabine; Drug: Dolutegravir

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04862975

HHSN275201800003I (Other Grant/Funding Number)

Pro00107262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Mothers/Infants:

1. 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.

2. Informed consent, according to local IRB/REB/IEC guidelines, prior to any study-related procedures.

3. 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.

4. Mother participant is fluent in English or Setswana.

5. 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:

1. 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.
2. Known pregnancy of mother during sample collection.
3. Mother has pumped any breastmilk at all in between the last 6 direct infant feedings prior to sample collection.
4. Infant was fed breastmilk in any manner besides nursing at mother's breast for any of the last 6 feedings prior to sample collection.
5. Previous enrollment on this study.

Trial design

164 participants in 1 patient group

Drug of Interest

Description:

Lactating moms receiving one or more antiretroviral drugs and their breastmilk fed infants per standard of care.

Treatment:

Drug: Dolutegravir

Drug: Emtricitabine

Drug: Lamivudine

Drug: Tenofovir Disoproxil Fumarate