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

Recruiting

• Conditions: HIV-1-infection
• Interventions: Diagnostic Test: Therapeutic drug monitoring in plasma of mother and child and in breastmilk

• Registration Number: NCT05642481
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-08
• Study Start: 2023-03-01
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antiretroviral drugs with marketing authorisation in Europe	Therapeutic drug monitoring in plasma of mother and child and in breastmilk	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

Primary Outcome Measures

Name	Time	Method
Breastmilk to maternal plasma ratio	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 Outcome Measures

Name	Time	Method
Viral load in breastmilk	6 months post partum	HIV RNA (copies/ml)
Absolute infant dose	6 months post partum	(AID; µg/kg/day) = Cmilk \* Vmilk
Relative infant dose	6 months post partum	Dosage infant (AID)/dosage mother
Comparison of absolute infant dose to approved pediatric dose	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)

Trial Locations

Locations (3)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands

Amsterdamumc; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Erasmusmc; 🇳🇱 Rotterdam, Zuid Holland, Netherlands