Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV-1-infection
- Sponsor
- Radboud University Medical Center
- Enrollment
- 16
- Locations
- 3
- Primary Endpoint
- Breastmilk to maternal plasma ratio
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •No exclusion criteria will be used at the screening for the trial.
Outcomes
Primary Outcomes
Breastmilk to maternal plasma ratio
Time Frame: 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 Outcomes
- Absolute infant dose(6 months post partum)
- Relative infant dose(6 months post partum)
- Comparison of absolute infant dose to approved pediatric dose(6 months post partum)
- Viral load in breastmilk(6 months post partum)