HIV InfectionsPhase 1NCT04900974

Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women

A Phase 1 study testing Doravirine in people with HIV Infections and Pregnancy Related, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: HIV Infections, Pregnancy Related
What is being tested?: Doravirine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 9 Jun 2022to 8 Apr 2025
Phase: Phase 1
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Pregnant women living with Human Immunodeficiency Virus (HIV) ≥18 years of age
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the trial.
On stable combination Antiretroviral Therapy (cART) for at least 30 days prior to enrollment
Plasma HIV RNA < 50 copies/mL within 90 days prior to enrollment
Ability and willingness of participant to not change their cART regimen to avoid any confounding of pharmacokinetic (PK) parameters.

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o Note: Women who change cART regimens will be replaced.
Aspartate aminotransferase and alanine aminotransferase < 3x Upper Limit of Normal (ULN)
Hemoglobin lower than Division of AIDs (Acquired Immunodeficiency Syndrome) (DAIDs) Grade 2 (9.0 g/dL)

Who cannot join

Women with multiple gestation, active opportunistic infections, present obstetrical complications that would deem them unsuitable for study participation, or evidence of fetal anomalies in present pregnancy will be excluded.
Women with severe renal impairment, end stage renal disease, undergoing dialysis, or severe hepatic impairment (Child-Pugh C)
Women with a significant illness/condition at the time of enrollment that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or assessment of safety.
Women with pregnancies that have become complicated are excluded for safety reasons.
Active hepatitis C (HCV) infection as defined by anti-hepatitis C virus serology (as determined by multi-antigen EIA) and detectable HCV RNA.
Clinically significant labs greater than Grade 2 on the NIH Division of AIDs Table for Grading the Severity of Adult and Pediatric Adverse events
Receiving CYP3A inducers including carbamazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, or St. John's wort or other drugs, including antiretrovirals, that influence drug concentration or alter pharmacokinetic profiles (atazanavir, maraviroc, darunavir, norvir, efavirenz, tipranavir)
Receiving moderate to strong cytochrome p450 3A (CYP3A) inhibitors including clarithromycin, boceprevir, cobicistat, danoprevir and ritonavir, elvitegravir and ritonavir, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, paritaprevir and ritonavir, posaconazole, ritonavir, saquinavir and ritonavir, telaprevir, tipranavir and ritonavir, grapefruit juice, idelalisib, nefazodone, and nelfinavir.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

The purpose of this research study is to evaluate the effect of body changes in pregnancy on doravirine concentrations, to determine what dose of doravirine should be used. Study participants will remain on their normal antiretroviral medications (ARVs) while participating in this study as prescribed by their regular clinic provider. Study participants will come to the research clinic for three sampling visits throughout their time as a participant. Study participants will only take one dose of doravirine during each sampling visit, which will occur during the 2nd and 3rd trimesters, as well as after their baby is delivered. This study was designed intentionally to not give a dose of doravirine in the first trimester when there is the greatest chance for all drugs to potentially cause injury to the baby. Study participants that choose to participate in this study may be enrolled for up to 10 months depending on the length of their pregnancy and how the visits are scheduled.

Read the detailed description

Antiretroviral (ARV) medications are used to treat infection with human immunodeficiency virus (HIV). During pregnancy, ARV therapy keeps women healthy and decreases the spread of HIV to their babies (<1-2%).

Many changes occur in the body during pregnancy, which can alter the concentrations of drug in the body. Doravirine (DOR) is a Food and Drug Administration (FDA) approved ARV, but the extent to which the drug concentrations of doravirine change during pregnancy is unknown. Because these changes are unknown, DOR has not been approved by the FDA for use among pregnant women; however, the FDA has given the researchers permission to use it in this study Pregnant women are often excluded from clinical trials, so it can take several years after a drug gets approved before contemporary ARV is available to them.

Conditions: HIV Infections, Pregnancy Related
Being tested: Doravirine
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DoravirineDrug
100mg

Study groups in NCT04900974
Study group	Role	What they receive
Doravirine	Experimental	100mg doravirine given by mouth once at each sampling visit. Receives: Drug: Doravirine

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy
To describe single-dose total and protein-unbound Cmax of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Measured: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy
To describe single-dose total and protein-unbound Tmax of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Measured: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy
To describe single-dose total and protein-unbound C12h of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Measured: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy
To describe single-dose total and protein-unbound C24 of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Measured: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of Doravirine During Pregnancy
To describe single-dose total and protein-unbound AUC of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Measured: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.

Secondary outcomes (1)

Number of Adverse Events Reported After Single Doses of Doravirine in Pregnant Participants
To evaluate the number of Adverse Events reported after single doses of doravirine in pregnant participants living with HIV
Measured: From enrollment visit to follow-up visit, an average of 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 20228 Apr 2025

First posted25 May 2021
Study start9 Jun 2022
Primary completion27 Mar 2025
Study completion8 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04900974
Sponsor's protocol ID: 20-0052
Status last verified: May 2025
First submitted: 13 May 2021
Last updated: 16 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

Poliseno A, Rahangdale L, Gay C, Trawick Roberts E, Kashuba A. Single-Dose Longitudinal Pharmacokinetic Evaluation of Doravirine in Pregnant Women Living With HIV: Protocol for a Phase 1 Study. JMIR Res Protoc. 2026 Jul 10;15:e89990. doi: 10.2196/89990.
PubMed 42429665

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
ClinicalTrials.gov ID: NCT04900974
Acronym / sponsor ID: 20-0052
Conditions: HIV Infections, Pregnancy Related
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 9 Jun 2022 (actual)
Primary completion: 27 Mar 2025 (actual)
Study completion: 8 Apr 2025 (actual)
First posted: 25 May 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Doravirine	Experimental	Drug: Doravirine100mg doravirine given by mouth once at each sampling visit.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Pregnant women living with Human Immunodeficiency Virus (HIV) ≥18 years of age
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the trial.
On stable combination Antiretroviral Therapy (cART) for at least 30 days prior to enrollment
Plasma HIV RNA < 50 copies/mL within 90 days prior to enrollment

Key exclusion criteria (8 listed)

Women with multiple gestation, active opportunistic infections, present obstetrical complications that would deem them unsuitable for study participation, or evidence of fetal anomalies in present pregnancy will be excluded.
Women with severe renal impairment, end stage renal disease, undergoing dialysis, or severe hepatic impairment (Child-Pugh C)
Women with a significant illness/condition at the time of enrollment that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or assessment of safety.
Women with pregnancies that have become complicated are excluded for safety reasons.
Active hepatitis C (HCV) infection as defined by anti-hepatitis C virus serology (as determined by multi-antigen EIA) and detectable HCV RNA.

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
Doravirine100mg	Drug	Doravirine

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy
Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
To describe single-dose total and protein-unbound Cmax of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy
Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
To describe single-dose total and protein-unbound Tmax of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy
Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
To describe single-dose total and protein-unbound C12h of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy
Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
To describe single-dose total and protein-unbound C24 of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum
Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of Doravirine During Pregnancy
Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.
To describe single-dose total and protein-unbound AUC of doravirine in the blood plasma of women living with HIV during the 2nd trimester, 3rd trimester, and post-partum

1 secondary outcome

Number of Adverse Events Reported After Single Doses of Doravirine in Pregnant Participants
Time frame: From enrollment visit to follow-up visit, an average of 10 months

Results and safety

Results posted to the registry on 16 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Doravirine	7	5

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy

Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.. Median (Full Range). Unit: ng/mL

Measure	Doravirine n = 5
2nd Trimester (20-26wks), Total	1340 (884 to 1420)
3rd Trimester (30-34wks), Total	928 (717 to 1500)
Post Partum (4-8wks), Total	1060 (521 to 1720)
2nd Trimester (20-26wks), Unbound	252 (194 to 299)
3rd Trimester (30-34wks), Unbound	192 (137 to 303)
Post Partum (4-8wks), Unbound	210 (103 to 350)

Doravirine: p = 0.400, Friedman's
Doravirine: p = 0.200, Friedman's

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Doravirine During Pregnancy

Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.. Median (Full Range). Unit: Hours

Measure	Doravirine n = 5
2nd Trimester (20-26wks), Total	1 (1 to 2)
3rd Trimester (30-34wks), Total	1 (1 to 4.13)
Post Partum (4-8wks), Total	1.98 (0.5 to 6)
2nd Trimester (20-26wks), Unbound	1 (1 to 2)
3rd Trimester (30-34wks), Unbound	1 (0.5 to 4.13)
Post Partum (4-8wks), Unbound	1.98 (0.5 to 6)

Primary outcome: Concentration of Doravirine at 12 Hours (C12) Postdose Doravirine During Pregnancy

Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.. Median (Full Range). Unit: ng/mL

Measure	Doravirine n = 5
2nd Trimester (20-26wks), Total	431 (260 to 465)
3rd Trimester (30-34wks), Total	333 (261 to 547)
Post Partum (4-8wks), Total	689.500 (281 to 876)
2nd Trimester (20-26wks), Unbound	81.620 (53.914 to 94.074)
3rd Trimester (30-34wks), Unbound	65.124 (51.399 to 141.189)
Post Partum (4-8wks), Unbound	129.798 (58.264 to 152.312)

Primary outcome: Concentration of Doravirine at 24 Hours (C24) Postdose Doravirine During Pregnancy

Time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.. Median (Full Range). Unit: ng/mL

Measure	Doravirine n = 5
2nd Trimester (20-26wks), Total	210 (86 to 292)
3rd Trimester (30-34wks), Total	172 (82 to 330)
Post Partum (4-8wks), Total	425 (174 to 475)
2nd Trimester (20-26wks), Unbound	38 (18 to 65)
3rd Trimester (30-34wks), Unbound	32 (16 to 65)
Post Partum (4-8wks), Unbound	78 (35 to 97)

Doravirine: p = 0.010, Friedman's
Doravirine: p = 0.007, Friedman's

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the time of signing informed consent through the follow-up visit, approximately 10 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Doravirine	0 of 5 (0%)	0 of 5 (0%)	0 of 5

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.
Derived from this study: PubMed 42429665Poliseno A, Rahangdale L, Gay C, Trawick Roberts E, Kashuba A. Single-Dose Longitudinal Pharmacokinetic Evaluation of Doravirine in Pregnant Women Living With HIV: Protocol for a Phase 1 Study. JMIR Res Protoc. 2026 Jul 10;15:e89990. doi: 10.2196/89990.
Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

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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 Kashuba, PharmD principal investigator

UNC Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Doravirine in people with HIV Infections and Pregnancy Related, run by University of North Carolina, Chapel Hill at 1 site in United States.

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 9 inclusion and 8 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Maximum Observed Plasma Concentration (Cmax) of Doraviraine During Pregnancy (time frame: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72 and hours post-dose in each period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04900974, which also lists 1 linked publication.

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.