Clincosm LogoSign in Get a demo

BMS02: Pharmacokinetic and Safety of Antiretroviral and Related Drugs in Lactating Women and Breastmilk Fed Infants

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04862975
Collaborator
The Emmes Company, LLC (Industry)
200
Enrollment
4
Locations
8.7
Anticipated Duration (Months)
50
Patients Per Site
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Pharmacokinetic and Safety of Antiretroviral and Related Drugs in Lactating Women and Breastmilk Fed Infants
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 27, 2022
Anticipated Study Completion Date :
May 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Drug of Interest

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

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.
Other Names:
  • Dolutegravir Sodium
  • DTG

    • Drug: Efavirenz
    Efavirenz will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
    Other Names:
  • EFV

    • 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.
    Other Names:
  • FTC

    • 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.
    Other Names:
  • Tenofovir DF
  • TDF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PK of selected DOIs in lactating women and breastmilk fed infants as measured by drug concentration in breastmilk. [Baseline]

      Drug concentration in breastmilk

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

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

    3. 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) [Baseline]

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

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

      Elimination Half-life (t1/2)

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

      Elimination rate constant (kel)

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

      Absorption rate constant (ka)

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

      Area under the curve (AUC)

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

      Maximum concentration (CMAX)

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

      Time to reach maximum concentration (TMAX)

    Secondary Outcome Measures

    1. Safety profile of antiretroviral drugs and other related drugs in infants exposed to drugs in breastmilk will be performed through monitoring of adverse events. [Up to 240 days]

      See Cohorts 1-4 for listing of drugs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria Mothers/Infants:

    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. Mother must have taken all DOIs 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 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Botswana-UPenn Partnership Botswana Gaborone South Africa
    2 Lesirane Clinic Botswana Gaborone South Africa
    3 Mogoditshane Clinic KDC Botswana Gaborone South Africa
    4 Old Naledi Clinic Botswana Gaborone South Africa

    Sponsors and Collaborators

    • Duke University
    • The Emmes Company, LLC

    Investigators

    • Principal Investigator: Matt Kelly, MD, Duke University
    • Principal Investigator: Kevin Watt, MD, University of Utah
    • Principal Investigator: Stephen Balevic, MD, Duke University
    • Principal Investigator: Kanecia Zimmerman, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT04862975
    Other Study ID Numbers:
    • Pro00107262
    • HHSN275201800003I
    First Posted:
    Apr 28, 2021
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    HIV Infections
    Tenofovir
    Emtricitabine
    Efavirenz
    Dolutegravir

    Study Results

    No Results Posted as of Aug 22, 2022