CompletedNot Applicable

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

South Africa164 participantsStarted 2024-01-09

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

Drug concentration in maternal plasma

Timeframe: Baseline

Drug concentration in maternal breastmilk

Timeframe: Baseline

Drug concentration in infant plasma

Timeframe: Baseline

Milk/Plasma ratio

Timeframe: Baseline

Estimated daily infant dose

Timeframe: Baseline

Relative infant dose

Timeframe: Baseline

Infant/maternal exposure ratio

Timeframe: Baseline

Trial details

NCT IDNCT04862975

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Lactating Women on Select DOI trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

Drug concentration in maternal plasma

Timeframe: Baseline

Drug concentration in maternal breastmilk

Timeframe: Baseline

Drug concentration in infant plasma

Timeframe: Baseline

Milk/Plasma ratio

Timeframe: Baseline

Estimated daily infant dose

Timeframe: Baseline

Relative infant dose

Timeframe: Baseline

Infant/maternal exposure ratio

Timeframe: Baseline