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

NCT ID: NCT04862975

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2025-01-30

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Drug of Interest

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

Dolutegravir

Intervention Type: DRUG

Dolutegravir will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.

Lamivudine

Intervention Type: DRUG

Lamivudine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.

Emtricitabine

Intervention Type: DRUG

Emtricitabine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.

Tenofovir Disoproxil Fumarate

Intervention Type: DRUG

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.

Interventions

Dolutegravir

Dolutegravir will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Dolutegravir Sodium; DTG; 3TC; FTC; Tenofovir DF; TDF

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matt Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Kevin Watt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Stephen Balevic, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Angelique Boutzoukas, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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

Countries

South Africa

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Related Links

https://www.fda.gov/media/124749/download

FDA: Clinical Lactation Studies: Considerations for Study Design Guidance for Industry

Other Identifiers

HHSN275201800003I

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00107262

Identifier Type: -

Identifier Source: org_study_id