Clinical trial NCT05642481: Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
Official title: Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1-infection
Keywords: Breastfeeding
Therapeutic drug monitoring
Breast milk to maternal plasma ratio
Antiretroviral therapy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Erasmus Medical Center
name: UMC Utrecht
First posted: 2022-12-08
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women living with HIV using antiretroviral medication who chose to breastfeed their child

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Breastmilk to maternal plasma ratio
timeFrame: 6 months post partum
Secondary outcomes:
measure: Absolute infant dose
timeFrame: 6 months post partum
measure: Relative infant dose
timeFrame: 6 months post partum
measure: Comparison of absolute infant dose to approved pediatric dose
timeFrame: 6 months post partum
measure: Viral load in breastmilk
timeFrame: 6 months post partum
Other outcomes:
measure: Adverse events in infant
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
measure: The place of the infant in population-specific percentile distributions of weight for age
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
measure: HIV RNA in infant
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
measure: Adverse events in mother
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
measure: Kidney function
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
measure: Alanine aminotranferase in mother
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
measure: Bilirubin in mother
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
measure: Hemoglobin in mother
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
measure: HIV RNA in mother
timeFrame: At every follow up visit (1,2,3,4,5,6 months post partum)
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdamumc
state: Noord Holland
city: Rotterdam
country: Netherlands
facility: Erasmusmc
state: Zuid Holland
Study officials:
References: