NCT04862975View on ClinicalTrials.gov

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

CompletedOBSERVATIONAL
Enrollment

164

Participants

Timeline

Start Date

January 9, 2024

Primary Completion Date

January 30, 2025

Study Completion Date

January 30, 2025

Conditions
Lactating Women on Select DOIBreastmilk Fed Infants of Mothers on Select DOIHIV Infections
Interventions
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.

Trial Locations (4)

Unknown

Botswana-UPenn Partnership, Botswana

Lesirane Clinic, Botswana

Mogoditshane Clinic KDC, Botswana

Old Naledi Clinic, Botswana

Sponsors

Lead Sponsor

Duke University
All Listed Sponsors
collaborator

The Emmes Company, LLC

INDUSTRY

lead

Duke University

OTHER

NCT04862975 - Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana | Biotech Hunter | Biotech Hunter