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

NCT04862975 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Matt Kelly, MD · Duke University

  • Kevin Watt, MD · University of Utah

  • Stephen Balevic, MD · Duke University

  • Angelique Boutzoukas, MD · Duke University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862975 on ClinicalTrials.gov