NCT05642481Completed
Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 16 (actual)
- First submitted
- 9 Nov 2022
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Radboud University Medical Center
- Diseases
- HIV
- NCT number
- NCT05642481
What you commit to
- Study type: Observational
- Participants enrolled: 16
- From 1 Mar 2023 to the primary completion date, 1 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- No exclusion criteria will be used at the screening for the trial.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AmsterdamUMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| ErasmusMC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.