CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 164 enrolled
Drug / intervention
Dolutegravir +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04862975
NCT04862975N/ACompleted
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Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

Duke University·observational·Posted Apr 28, 2021·Updated Feb 6, 2025

In Brief

An observational study evaluating Dolutegravir, Lamivudine, and 2 other interventions for Lactating Women on Select DOI and 2 related conditions. Completed, enrolled 164 participants across 4 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLactating Women on Select DOI, Breastmilk Fed Infants of Mothers on Select DOI, HIV Infections
CountriesSouth Africa
CollaboratorsThe Emmes Company, LLC

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 28, 2021
Enrollment StartJan 9, 2024
Primary CompletionJan 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.2 years ago

Interventions

Dolutegravirdrug

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

Lamivudinedrug

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

Emtricitabinedrug

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 Fumaratedrug

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.