PANNA-B TDM: Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Measurement of drug concentration in plasma of mother and if possible of child and in breastmilk
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Outcome Measures
Primary Outcome Measures
- 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
- 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)
- Viral load in breastmilk [6 months post partum]
HIV RNA (copies/ml)
Other Outcome Measures
- Adverse events in infant [At every follow up visit (1,2,3,4,5,6 months post partum)]
As reported by the parents/caregivers and/or paediatrician
- 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)]
(copies/ml)
- Adverse events in mother [At every follow up visit (1,2,3,4,5,6 months post partum)]
As reported by mother and/or treating physician
- Kidney function [At every follow up visit (1,2,3,4,5,6 months post partum)]
(estimated glomerular filtration rate - KDIGO)
- Alanine aminotranferase in mother [At every follow up visit (1,2,3,4,5,6 months post partum)]
- Bilirubin in mother [At every follow up visit (1,2,3,4,5,6 months post partum)]
- Hemoglobin in mother [At every follow up visit (1,2,3,4,5,6 months post partum)]
- HIV RNA in mother [At every follow up visit (1,2,3,4,5,6 months post partum)]
copies/ml
Eligibility Criteria
Criteria
Inclusion criteria
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Patients of at least 18 years of age at the moment of screening
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Patients with HIV-1 as documented with positive HIV antibody test, HIV RNA of antigen test
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Patients breastfeeding their infant
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Patients using antiretrovirals for the treatment of HIV-1 with a marketing authorisation in Europe (table 1 in Appendix)
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Patients using current antiretrovirals for a minimum of 2 weeks to assure drug concentrations are in steady state
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Radboud University Medical Center
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Erasmus Medical Center
- UMC Utrecht
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PANNA-B TDM