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

NCT04862975 | Completed DMC

• 2 other identifiers: Pro00107262HHSN275201800003I
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Drug concentration in maternal plasma

  Drug concentration of a DOI in maternal plasma

  Baseline

• Drug concentration in maternal breastmilk

  Drug concentration of a DOI in maternal breastmilk

  Baseline

• Drug concentration in infant plasma

  Drug concentration of a DOI in infant plasma

  Baseline

• Milk/Plasma ratio

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

  Baseline

• Estimated daily infant dose

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

  Baseline

• Relative infant dose

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

  Baseline

• Infant/maternal exposure ratio

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

  Baseline

Other Outcomes (16)

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

  Baseline

• 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

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

  Baseline

Study Arms (1)

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

Dolutegravir DRUG

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

Drug of Interest

Lamivudine DRUG

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

Drug of Interest

Emtricitabine DRUG

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

Drug of Interest

Tenofovir Disoproxil Fumarate DRUG

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

Drug of Interest

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Informed consent, according to local IRB/REB/IEC guidelines, prior to any study-related procedures.
• 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.
• Mother participant is fluent in English or Setswana.
• Willing to provide at least 1 of the below required samples between the co-enrolled mother/infant pair:
• Maternal breastmilk
• Infant blood

You may not qualify if:

• 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.
• Known pregnancy of mother during sample collection.
• Mother has pumped any breastmilk at all in between the last 6 direct infant feedings prior to sample collection.
• Infant was fed breastmilk in any manner besides nursing at mother's breast for any of the last 6 feedings prior to sample collection.
• Previous enrollment on this study.

Sponsors & Collaborators

• Duke University: lead
• The Emmes Company, LLC: collaborator

Study Sites (4)

Botswana-UPenn Partnership

Botswana, Gaborone, South Africa

Location

Lesirane Clinic

Botswana, Gaborone, South Africa

Location

Mogoditshane Clinic KDC

Botswana, Gaborone, South Africa

Location

Old Naledi Clinic

Botswana, Gaborone, South Africa

Location

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Related Links

• UNICEF Botswana Key Demographic Indicators
• FDA: Clinical Lactation Studies: Considerations for Study Design Guidance for Industry

Biospecimen

Retention: SAMPLES WITH DNA

Leftover specimens will be sent to the National Institutes of Child Health and Human Development (NICHD) repository for unknown future use.

MeSH Terms

Conditions

HIV Infections

Interventions

dolutegravir; Lamivudine; Emtricitabine; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Matt Kelly, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Kevin Watt, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Stephen Balevic, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Angelique Boutzoukas, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 28, 2021
• Study Start: January 9, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded to the repository within 2 years of study completion. Biological samples will be stored indefinitely. If a participant decides to withdraw from the study, they will be instructed per the ICF to contact the site investigator. Study data and samples that have been recorded / collected prior to withdrawal will continue to be used, but no new data or samples will be collected.
• Access Criteria: In order to have access, researchers have to complete a Data access request. NICHD will review the request and either approve or deny it. IRB approval must be obtained by the researcher to access the data.

Locations

ZA (4)