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CompletedNCT04862975BMS02Updated Feb 6, 2025

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

An observational study in Lactating Women on Select DOI, Breastmilk Fed Infants of Mothers on Select DOI and HIV Infections, sponsored by Duke University. Completed at 4 sites in South Africa. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by Duke University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
164
Ages
18 Years and older
Sex
Female
01

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.

Read the 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.

02

Conditions studied

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

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 164 is below the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Approximately 50 eligible lactating women and their breastmilk fed infants per DOI will be co-enrolled. Participants may be enrolled for one or more DOIs with a single consent. The co-enrollment of mothers and more than 1 infant (multiple birth) is permitted.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
164 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Drug of Interest

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

    Drug: Dolutegravir · Drug: Lamivudine · Drug: Emtricitabine · Drug: Tenofovir Disoproxil Fumarate

Interventions

  • DrugDolutegravir

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

    Also known as: Dolutegravir Sodium, DTG

  • DrugLamivudine

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

    Also known as: 3TC

  • DrugEmtricitabine

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

    Also known as: FTC

  • DrugTenofovir 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.

    Also known as: Tenofovir DF, TDF

06

What researchers measure

Primary outcomes

  1. Drug concentration in maternal plasma

    Drug concentration of a DOI in maternal plasma

    Time frame: Baseline

  2. Drug concentration in maternal breastmilk

    Drug concentration of a DOI in maternal breastmilk

    Time frame: Baseline

  3. Drug concentration in infant plasma

    Drug concentration of a DOI in infant plasma

    Time frame: Baseline

  4. Milk/Plasma ratio

    The drug exposure of selected DOIs will be evaluated using milk/plasma ratio

    Time frame: Baseline

  5. Estimated daily infant dose

    The drug exposure of selected DOIs will be evaluated using the estimated daily infant dose

    Time frame: Baseline

  6. Relative infant dose

    The drug exposure of selected DOIs will be evaluated using relative infant dose

    Time frame: Baseline

  7. Infant/maternal exposure ratio

    The drug exposure of selected DOIs will be evaluated using infant/maternal exposure ratio

    Time frame: Baseline

Other outcomes

  1. PK of selected DOIs in lactating women and breastmilk fed infants as measured by Clearance (CL) or apparent clearance (CL/F).

    Clearance (CL) or apparent clearance (CL/F)

    Time frame: Baseline

  2. PK of selected DOIs in lactating women and breastmilk fed infants as measured by volume of distribution (V) or apparent volume of distribution (V/F)

    Volume of distribution (V) or apparent volume of distribution (V/F)

    Time frame: Baseline

  3. PK of selected DOIs in lactating women and breastmilk fed infants as measured by elimination Half-life (t1/2).

    Elimination Half-life (t1/2)

    Time frame: Baseline

  4. PK of selected DOIs in lactating women and breastmilk fed infants as measured by absorption rate constant (ka).

    Absorption rate constant (ka)

    Time frame: Baseline

  5. PK of selected DOIs in lactating women and breastmilk fed infants as measured by area under the curve (AUC).

    Area under the curve (AUC)

    Time frame: Baseline

  6. PK of selected DOIs in lactating women and breastmilk fed infants as measured by elimination rate constant (kel).

    Elimination rate constant (kel)

    Time frame: Baseline

  7. PK of selected DOIs in lactating women and breastmilk fed infants as measured by maximum concentration (CMAX).

    Maximum concentration (CMAX)

    Time frame: Baseline

  8. PK of selected DOIs in lactating women and breastmilk fed infants as measured by time to reach maximum concentration (TMAX).

    Time to reach maximum concentration (TMAX)

    Time frame: Baseline

  9. Correlation of PK parameters (drug concentration in maternal breastmilk) with maternal BMI

    Correlation of drug concentration of each DOI in maternal breastmilk with maternal BMI

    Time frame: Baseline

  10. Correlation of PK parameters (drug concentration in maternal plasma) with maternal BMI

    Correlation of drug concentration of each DOI in maternal plasma with maternal BMI

    Time frame: Baseline

  11. Correlation of PK parameters (drug concentration in infant plasma) with maternal BMI

    Correlation of drug concentration of each DOI in infant plasma with maternal BMI

    Time frame: Baseline

  12. Correlation of PK parameters (milk/plasma ratio) with maternal BMI

    Correlation of milk/plasma ratio of each DOI with maternal BMI

    Time frame: Baseline

  13. Correlation of PK parameters (estimated daily infant dose) with maternal BMI

    Correlation of estimated daily infant dose of each DOI with maternal BMI

    Time frame: Baseline

  14. Correlation of PK parameters (relative infant dose) with maternal BMI

    Correlation of relative infant dose of each DOI with maternal BMI

    Time frame: Baseline

  15. Correlation of PK parameters (infant/maternal exposure ratio) with maternal BMI

    Correlation of infant/maternal exposure ratio for each DOI with maternal BMI

    Time frame: Baseline

  16. Safety ESIs for infants

    Will be collected from the medical record at the time of sample collection

    Time frame: Baseline

07

Study locations

4 sites
  • 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
08

References and documents

Publications

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Individual participant data

Plan to share: Yes — After the study is completed, information about the study, including de-identified study data, will be submitted to the NIH data repository (https://dash.nichd.nih.gov and referred to below as "DASH"). With NIH approval, the data submitted to DASH may be used by other researchers for future research. The study data submitted to DASH will be de-identified, meaning it will not include any information that can identify the participant. The study team may also share the de-identified study data with other researchers. When the participant's de-identified study data are provided to other researchers for the purposes of future research, it will be done without obtaining additional permission from the participant.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04862975
Lead sponsor
Duke University
Collaborators
The Emmes Company, LLC
Responsible party
Sponsor
First posted
Apr 28, 2021
Start date
Jan 9, 2024
Primary completion
Jan 30, 2025
Completion
Jan 30, 2025
Last update
Feb 6, 2025

Study contacts

Matt Kelly, MD
principal investigator · Duke University
Kevin Watt, MD
principal investigator · University of Utah
Stephen Balevic, MD
principal investigator · Duke University
Angelique Boutzoukas, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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