HIV-1-infectionPANNA-B TDMNCT05642481
Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
An observational study of HIV-1-infection, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Therapeutic drug monitoring in plasma of mother and child and in breastmilk
- How many people
- 16 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Mar 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women living with HIV using antiretroviral medication who chose to breastfeed their child
Who may be able to join
- 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
Who cannot join
- No exclusion criteria will be used at the screening for the trial.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Amsterdamumc
Amsterdam, North Holland
Radboudumc
Nijmegen, Gelderland, 6525GA
Erasmusmc
Rotterdam, South Holland
About this study
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.
- Conditions
- HIV-1-infection
- Being tested
- Therapeutic drug monitoring in plasma of mother and child and in breastmilk
- Keywords
- Breastfeeding, Therapeutic drug monitoring, Breast milk to maternal plasma ratio, Antiretroviral therapy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic drug monitoring in plasma of mother and child and in breastmilkDiagnostic test
Measurement of drug concentration in plasma of mother and if possible of child and in breastmilk
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Therapeutic drug monitoring in plasma of mother and child and in breastmilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post partum
Secondary outcomes (4)
Absolute infant dose
(AID; µg/kg/day) = Cmilk * Vmilk
Measured: 6 months post partum
Relative infant dose
Dosage infant (AID)/dosage mother
Measured: 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)
Measured: 6 months post partum
Viral load in breastmilk
HIV RNA (copies/ml)
Measured: 6 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Mar 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam University Medical Center, Erasmus Medical Center, UMC Utrecht
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642481
- Sponsor's protocol ID
- PANNA-B TDM
- Acronym
- PANNA-B TDM
- Status last verified
- Apr 2025
- First submitted
- 9 Nov 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
- ClinicalTrials.gov ID
- NCT05642481
- Acronym / sponsor ID
- PANNA-B TDM / PANNA-B TDM
- Conditions
- HIV-1-infection
- Keywords
- Breastfeeding, Therapeutic drug monitoring, Breast milk to maternal plasma ratio, Antiretroviral therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Amsterdam University Medical Center, Erasmus Medical Center, UMC Utrecht
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiretroviral drugs with marketing authorisation in Europe | – | Diagnostic Test: Therapeutic drug monitoring in plasma of mother and child and in breastmilkThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women living with HIV using antiretroviral medication who chose to breastfeed their child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria will be used at the screening for the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic drug monitoring in plasma of mother and child and in breastmilkMeasurement of drug concentration in plasma of mother and if possible of child and in breastmilk | Diagnostic test | Antiretroviral drugs with marketing authorisation in Europe |
Primary outcome
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.
4 secondary outcomes
Absolute infant dose
Time frame: 6 months post partum
Relative infant dose
Time frame: 6 months post partum
Comparison of absolute infant dose to approved pediatric dose
Time frame: 6 months post partum
Viral load in breastmilk
Time frame: 6 months post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for HIV-1-infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Radboud University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastmilk to maternal plasma ratio (time frame: 6 months post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.