HIV-1-infection
Conditions
Keywords
Breastfeeding, Therapeutic drug monitoring, Breast milk to maternal plasma ratio, Antiretroviral therapy
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.
Interventions
DIAGNOSTIC_TESTTherapeutic 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
Sponsors
Amsterdam University Medical Center
Erasmus Medical Center
UMC Utrecht
Radboud University Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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 |
| HIV RNA in mother | At every follow up visit (1,2,3,4,5,6 months post partum) | copies/ml |
| Hemoglobin in mother | 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) | (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) |
Countries
Netherlands
Outcome results
None listed