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

NCT05642481 | Completed

• 1 other identifier: PANNA-B TDM
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV-1-infection

Keywords

Breastfeeding; Therapeutic drug monitoring; Breast milk to maternal plasma ratio; Antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• Breastmilk to maternal plasma ratio

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

  6 months post partum

Secondary Outcomes (4)

• Absolute infant dose

  6 months post partum

• Relative infant dose

  6 months post partum

• Comparison of absolute infant dose to approved pediatric dose

  6 months post partum

• Viral load in breastmilk

  6 months post partum

Other Outcomes (9)

• Adverse events in infant

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

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

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

• HIV RNA in infant

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

Study Arms (1)

Antiretroviral drugs with marketing authorisation in Europe

This study includes subjects who already take antiretroviral drugs to treat HIV-1 with a marketing authorisation in Europe. These drugs already have a marketing authorisation and are prescribed by the treating physician of the subject. No adjustments to their treating regimen are made in order to participate in this study. All antiretrovirals with a marketing authorisation in Europe are eligible for inclusion in this study, but most subjects are expected to use a backbone of nucleoside reverse transcriptase inhibitors combined with either dolutegravir, raltegravir, darunavir or rilpivirine

Diagnostic Test: Therapeutic drug monitoring in plasma of mother and child and in breastmilk

Interventions

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

Antiretroviral drugs with marketing authorisation in Europe

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women living with HIV using antiretroviral medication who chose to breastfeed their child

You may qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Amsterdam University Medical Center: collaborator
• Erasmus Medical Center: collaborator
• UMC Utrecht: collaborator

Study Sites (3)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Amsterdamumc

Amsterdam, North Holland, Netherlands

Location

Erasmusmc

Rotterdam, South Holland, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

breastmilk, maternal plasma and infant plasma

MeSH Terms

Conditions

Breast Feeding

Interventions

Drug Monitoring

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 8, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-04

Locations

NL (3)