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Completed

NCT Number: NCT05642481

Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed

This is a prospective, multi-center, longitudinal, mother-infant pair, therapeutic drug monitoring study. The aim of this study is to determine concentrations of antiretroviral drugs in plasma and breastmilk in people living with HIV who chose to breastfeed while using antiretrovirals. At a planned hospital visit an extra maternal blood sample (1 to 2 per visit) and extra infant blood sample (1 per visit) will be collected, as well as a breastmilk sample (1 to 2 per visit). Ideally, sample collection will take place at least during the 1, 3 and 6 month post partum follow up visit. Measured concentrations will be used to calculate milk to plasma ratios, relative and absolute infant dosages.

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Key information

Conditions

HIV-1-infection Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Radboudumc, Nijmegen, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of at least 18 years of age at the moment of screening
  • Patients with HIV-1 as documented with positive HIV antibody test, HIV RNA of antigen test
  • Patients breastfeeding their infant
  • Patients using antiretrovirals for the treatment of HIV-1 with a marketing authorisation in Europe (table 1 in Appendix)
  • Patients using current antiretrovirals for a minimum of 2 weeks to assure drug concentrations are in steady state
  • Patients who are able and willing to sign an informed consent

Exclusion criteria

No exclusion criteria will be used at the screening for the trial.

Treatment and study plan

Therapeutic drug monitoring in plasma of mother and child and in breastmilk

Diagnostic Test

Measurement of drug concentration in plasma of mother and if possible of child and in breastmilk

Primary outcomes

  1. Breastmilk to maternal plasma ratio

    Time frame: 6 months post partum

    Total concentration of antiretrovirals in breastmilk and plasma of the mother at a single time point to determine milk to plasma ratio.

Secondary outcomes

  1. Absolute infant dose

    Time frame: 6 months post partum

    (AID; µg/kg/day) = Cmilk * Vmilk

  2. Relative infant dose

    Time frame: 6 months post partum

    Dosage infant (AID)/dosage mother

  3. Comparison of absolute infant dose to approved pediatric dose

    Time frame: 6 months post partum

    For agents approved for pediatric use the absolute infant dose is compared to the approved pediatric dose (abacavir, emtricitabine, lamivudine, zidovudine, efavirenz, nevirapine, atazanavir, lopinavir, maraviroc, dolutegravir, raltegravir, ritonavir)

  4. Viral load in breastmilk

    Time frame: 6 months post partum

    HIV RNA (copies/ml)

Other outcomes

  1. Adverse events in infant

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

    As reported by the parents/caregivers and/or paediatrician

  2. The place of the infant in population-specific percentile distributions of weight for age

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

  3. HIV RNA in infant

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

    (copies/ml)

  4. Adverse events in mother

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

    As reported by mother and/or treating physician

  5. Kidney function

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

    (estimated glomerular filtration rate - KDIGO)

  6. Alanine aminotranferase in mother

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

  7. Bilirubin in mother

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

  8. Hemoglobin in mother

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

  9. HIV RNA in mother

    Time frame: At every follow up visit (1,2,3,4,5,6 months post partum)

    copies/ml

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Amsterdam University Medical Center
  • Erasmus Medical Center
  • UMC Utrecht

Registry information

Acronym: PANNA-B TDM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2022
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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