Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amsterdam University Medical Center | OTHER |
| Erasmus Medical Center | OTHER |
| UMC Utrecht | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute infant dose | (AID; µg/kg/day) = Cmilk * Vmilk | 6 months post partum |
| Relative infant dose | Dosage infant (AID)/dosage mother |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| The place of the infant in population-specific percentile distributions of weight for age |
Inclusion criteria
Exclusion Criteria:
No exclusion criteria will be used at the screening for the trial.
Not provided
Not provided
Not provided
women living with HIV using antiretroviral medication who chose to breastfeed their child
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525GA | Netherlands | ||
| Amsterdamumc |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 19, 2026 | |
| Reset | Mar 12, 2026 |
Not provided
Not provided
Not provided
Not provided
breastmilk, maternal plasma and infant plasma
| 6 months post partum |
| 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 |
| Viral load in breastmilk | HIV RNA (copies/ml) | 6 months post partum |
| At every follow up visit (1,2,3,4,5,6 months post partum) |
| HIV RNA in infant | (copies/ml) | At every follow up visit (1,2,3,4,5,6 months post partum) |
| 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) |
| Kidney function | (estimated glomerular filtration rate - KDIGO) | At every follow up visit (1,2,3,4,5,6 months post partum) |
| 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 | copies/ml | At every follow up visit (1,2,3,4,5,6 months post partum) |
| Amsterdam |
| North Holland |
| Netherlands |
| Erasmusmc | Rotterdam | South Holland | Netherlands |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 19, 2026 | Mar 12, 2026 |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D016903 | Drug Monitoring |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided