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

HIV-1-infection Clinical Trial

— PANNA-B TDM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642481
• Other study ID #: PANNA-B TDM
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2022
• Source: Radboud University Medical Center
• Contact: Lena van der Wekken-Pas, MD
• Phone: 0031243611111
• Email: wendy.vanderwekken-pas[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Diagnostic Test:
• Therapeutic drug monitoring in plasma of mother and child and in breastmilk
Measurement of drug concentration in plasma of mother and if possible of child and in breastmilk

Locations

Country	Name	City	State
Netherlands	Amsterdamumc	Amsterdam	Noord Holland
Netherlands	Radboudumc	Nijmegen	Gelderland
Netherlands	Erasmusmc	Rotterdam	Zuid Holland

Sponsors (4)

Lead Sponsor	Collaborator
Radboud University Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events in infant	As reported by the parents/caregivers and/or paediatrician	At every follow up visit (1,2,3,4,5,6 months post partum)
Other	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)
Other	HIV RNA in infant	(copies/ml)	At every follow up visit (1,2,3,4,5,6 months post partum)
Other	Adverse events in mother	As reported by mother and/or treating physician	At every follow up visit (1,2,3,4,5,6 months post partum)
Other	Kidney function	(estimated glomerular filtration rate - KDIGO)	At every follow up visit (1,2,3,4,5,6 months post partum)
Other	Alanine aminotranferase in mother		At every follow up visit (1,2,3,4,5,6 months post partum)
Other	Bilirubin in mother		At every follow up visit (1,2,3,4,5,6 months post partum)
Other	Hemoglobin in mother		At every follow up visit (1,2,3,4,5,6 months post partum)
Other	HIV RNA in mother	copies/ml	At every follow up visit (1,2,3,4,5,6 months post partum)
Primary	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	Absolute infant dose	(AID; µg/kg/day) = Cmilk * Vmilk	6 months post partum
Secondary	Relative infant dose	Dosage infant (AID)/dosage mother	6 months post partum
Secondary	Comparison of absolute infant dose to approved pediatric dose	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)	6 months post partum
Secondary	Viral load in breastmilk	HIV RNA (copies/ml)	6 months post partum