HivPhase 4PANNA-B PKNCT05648201
Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers
A Phase 4 study testing Doravirine 100Mg Tab and Biktarvy 50/200/25 Tab in people with Hiv, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
No to little data exists on penetration of antiretroviral drugs in breastmilk. Too high concentrations may lead to infant toxicity and too low concentrations may lead to development of resistance in case the infant inadvertently becomes infected with the virus. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Doravirine 100Mg Tab and Biktarvy 50/200/25 Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to 28 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 18 years of age at the moment of screening
- At least 10 days post partum
- At the end of breastfeeding period; subject is able to produce breastmilk at least two times a day and is no longer feeding infant at start of study
- Able and willing to sign an informed consent
Who cannot join
- Relevant co-medication or comorbidity that might interfere with drug absorption, distribution, metabolism or excretion
- Inability to take drugs according to the instructions (i.e. with food)
- Presence of positive HIV screening or HIV RNA
- Presence of HBsAg or HBcAg without anti-HBs
- Presence of grade III/IV anaemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL).
- Presence of hereditary forms of severe galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
No to little data exists on penetration of antiretroviral drugs in breastmilk. Too high concentrations may lead to infant toxicity and too low concentrations may lead to development of resistance in case the infant inadvertently becomes infected with the virus.
The aim of this trial is to determine the concentration of currently often used ARV (doravirine, raltegravir, bictegravir, tenofovir alafenamide, emtricitabine) in breast milk after administration of a single dose Study design: This is a single centre, single dose, open label, pharmacokinetic study in healthy volunteers.
Read more
Study population: Adult, healthy volunteers at the end of their breastfeeding period Intervention: Administration of one dose of either doravirine (DOR) 100mg, raltegravir (RAL) 1200mg or a combination of tenofovir alafenamide 25mg, emtricitabine 200mg and bictegravir 50mg (BIC/FTC/TAF).
Main study parameters/endpoints: Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio.
Read the detailed description
Rationale: Although current guidelines advise against breastfeeding while using antiretrovirals in people living with HIV, some women choose to breastfeed because advantages of breastfeeding may exceed the possible risk of HIV transmission to the newborn. However, no sound recommendation can be made on which antiretrovirals are most suitable during breastfeeding, because no to little data on penetration of these drugs in breastmilk exist. Too high concentrations may lead to infant toxicity and too low concentrations may lead to development of resistance in case the infant inadvertently becomes infected with the virus.
Objective: to determine the concentration of currently often used ARV (doravirine, raltegravir, bictegravir, tenofovir alafenamide, emtricitabine) in breast milk after administration of a single dose Study design: This is a single centre, single dose, open label, pharmacokinetic study in healthy volunteers.
Study population: Adult, healthy volunteers at the end of their breastfeeding period Intervention: Administration of one dose of either doravirine (DOR) 100mg, raltegravir (RAL) 1200mg or a combination of tenofovir alafenamide 25mg, emtricitabine 200mg and bictegravir 50mg (BIC/FTC/TAF).
Main study parameters/endpoints: Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from this study, but will contribute to knowledge on breastmilk transfer of ARV and possibly enable people living with HIV to make an informed decision on breastfeeding while using these medications.
No harm is expected from participation in this study, but possible side effects should be anticipated. Known side effects of DOR are nausea (4%) and headache (3%), abnormal dreams and insomnia (1-10%), dizziness and somnolence and fatigue (1-10%). BIC/FTC/TAFs and RALs known side effects are: headache (5%), diarrhoea (5%) and nausea (4%), depression and abnormal dreams and fatigue (1-10%), suicidal ideation (0,1-1%), angio-edema (0,1-1%) and Steven Johnson syndrome (0,01-0,1%) and osteonecrosis (0,01-0,1%). Due to the fact that only one dose of the drugs will be ingested, the risk of development of one or more of these side effects is considered to be low.
Participation in this study requires subjects to be admitted for 12 hours, a visit the next morning and a return visit 7 days later. During the sampling day an intravenous indwelling catheter is installed for collection of blood samples. A total volume of 25-50ml of blood, 2 urine samples and 6 breastmilk samples (expressed using a personal electronic pump) are collected. No harm is to be expected from these sample collection procedures.
- Conditions
- Hiv
- Being tested
- Doravirine 100Mg Tab, Biktarvy 50/200/25 Tab
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doravirine 100Mg TabDrug
Also called pifeltro
1 single dose of 100mg taken orally
Biktarvy 50/200/25 TabDrug
Also called biktarvy
1 single dose of 50/200/25 taken orally
| Study group | Role | What they receive |
|---|---|---|
| Doravirine | Experimental | 1 single dose of 100mg doravirine taken orally Receives: Drug: Doravirine 100Mg Tab |
| Biktarvy | Experimental | 1 single dose of 25/200/50mg taken orally Receives: Drug: Biktarvy 50/200/25 Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
M:P Ratio
Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio
Measured: 24hours after ingestion of study drug
Secondary outcomes (6)
AUCtau
AUC over dosing interval
Measured: 24hours after ingestion of study drug
Cmax
Peak plasma concentration
Measured: Within 24 hours after ingestion of study drug
Ctrough
Concentration at the end of dosing interval
Measured: 24hours after ingestion of study drug
Clearance of Study Drugs
Clearance of the study drugs
Measured: 24hours after ingestion of study drug
Apparent Volume of Distribution
Apparent volume of distribution of study drug
Measured: 24hours after ingestion of study drug
Half Life
Half life of study drug
Measured: 24hours after ingestion of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Mar 2023
- Primary completion1 Nov 2024
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HivStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Angela Colbers, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648201
- Sponsor's protocol ID
- PANNA-B PK
- Acronym
- PANNA-B PK
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2022
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers
- ClinicalTrials.gov ID
- NCT05648201
- Acronym / sponsor ID
- PANNA-B PK / PANNA-B PK
- Conditions
- Hiv
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Merck Sharp & Dohme LLC
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Posted 16 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No to little data exists on penetration of antiretroviral drugs in breastmilk. Too high concentrations may lead to infant toxicity and too low concentrations may lead to development of resistance in case the infant inadvertently becomes infected with the virus.
The aim of this trial is to determine the concentration of currently often used ARV (doravirine, raltegravir, bictegravir, tenofovir alafenamide, emtricitabine) in breast milk after administration of a single dose Study design: This is a single centre, single dose, open label, pharmacokinetic study in healthy volunteers.
Study population: Adult, healthy volunteers at the end of their breastfeeding period Intervention: Administration of one dose of either doravirine (DOR) 100mg, raltegravir (RAL) 1200mg or a combination of tenofovir alafenamide 25mg, emtricitabine 200mg and bictegravir 50mg (BIC/FTC/TAF).
Main study parameters/endpoints: Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio.
Detailed description
Rationale: Although current guidelines advise against breastfeeding while using antiretrovirals in people living with HIV, some women choose to breastfeed because advantages of breastfeeding may exceed the possible risk of HIV transmission to the newborn. However, no sound recommendation can be made on which antiretrovirals are most suitable during breastfeeding, because no to little data on penetration of these drugs in breastmilk exist. Too high concentrations may lead to infant toxicity and too low concentrations may lead to development of resistance in case the infant inadvertently becomes infected with the virus.
Objective: to determine the concentration of currently often used ARV (doravirine, raltegravir, bictegravir, tenofovir alafenamide, emtricitabine) in breast milk after administration of a single dose Study design: This is a single centre, single dose, open label, pharmacokinetic study in healthy volunteers.
Study population: Adult, healthy volunteers at the end of their breastfeeding period Intervention: Administration of one dose of either doravirine (DOR) 100mg, raltegravir (RAL) 1200mg or a combination of tenofovir alafenamide 25mg, emtricitabine 200mg and bictegravir 50mg (BIC/FTC/TAF).
Main study parameters/endpoints: Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from this study, but will contribute to knowledge on breastmilk transfer of ARV and possibly enable people living with HIV to make an informed decision on breastfeeding while using these medications.
No harm is expected from participation in this study, but possible side effects should be anticipated. Known side effects of DOR are nausea (4%) and headache (3%), abnormal dreams and insomnia (1-10%), dizziness and somnolence and fatigue (1-10%). BIC/FTC/TAFs and RALs known side effects are: headache (5%), diarrhoea (5%) and nausea (4%), depression and abnormal dreams and fatigue (1-10%), suicidal ideation (0,1-1%), angio-edema (0,1-1%) and Steven Johnson syndrome (0,01-0,1%) and osteonecrosis (0,01-0,1%). Due to the fact that only one dose of the drugs will be ingested, the risk of development of one or more of these side effects is considered to be low.
Participation in this study requires subjects to be admitted for 12 hours, a visit the next morning and a return visit 7 days later. During the sampling day an intravenous indwelling catheter is installed for collection of blood samples. A total volume of 25-50ml of blood, 2 urine samples and 6 breastmilk samples (expressed using a personal electronic pump) are collected. No harm is to be expected from these sample collection procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doravirine | Experimental | Drug: Doravirine 100Mg Tab1 single dose of 100mg doravirine taken orally |
| Biktarvy | Experimental | Drug: Biktarvy 50/200/25 Tab1 single dose of 25/200/50mg taken orally |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At least 18 years of age at the moment of screening
- At least 10 days post partum
- At the end of breastfeeding period; subject is able to produce breastmilk at least two times a day and is no longer feeding infant at start of study
- Able and willing to sign an informed consent
Key exclusion criteria (6 listed)
- Relevant co-medication or comorbidity that might interfere with drug absorption, distribution, metabolism or excretion
- Inability to take drugs according to the instructions (i.e. with food)
- Presence of positive HIV screening or HIV RNA
- Presence of HBsAg or HBcAg without anti-HBs
- Presence of grade III/IV anaemia (i.e. Hb <4.6 mmol/L or <7.4 g/dL).
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 |
|---|---|---|
| Doravirine 100Mg TabAlso: pifeltro1 single dose of 100mg taken orally | Drug | Doravirine |
| Biktarvy 50/200/25 TabAlso: biktarvy1 single dose of 50/200/25 taken orally | Drug | Biktarvy |
Primary outcome
M:P Ratio
Time frame: 24hours after ingestion of study drug
Area under the plasma and milk concentration curve are used to calculate milk to plasma ratio
6 secondary outcomes
AUCtau
Time frame: 24hours after ingestion of study drug
Cmax
Time frame: Within 24 hours after ingestion of study drug
Ctrough
Time frame: 24hours after ingestion of study drug
Clearance of Study Drugs
Time frame: 24hours after ingestion of study drug
Apparent Volume of Distribution
Time frame: 24hours after ingestion of study drug
Half Life
Time frame: 24hours after ingestion of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Angela Colbers, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doravirine 100Mg Tab and Biktarvy 50/200/25 Tab in people with Hiv, run by Radboud University Medical Center at 1 site 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 4 inclusion and 6 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
M:P Ratio (time frame: 24hours after ingestion of study drug). 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 16 Apr 2026.