NCT04900974CompletedPhase 1
Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 13 May 2021
- Start date
- 9 Jun 2022
- Primary completion date
- 27 Mar 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- HIV
- NCT number
- NCT04900974
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 7
- From 9 Jun 2022 to the primary completion date, 27 Mar 2025
- 1 site 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.
Prior treatment
- 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.
Other illness
- 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.
- Active hepatitis C (HCV) infection as defined by anti-hepatitis C virus serology (as determined by multi-antigen EIA) and detectable HCV RNA.
Other
- Women with pregnancies that have become complicated are excluded for safety reasons.
- Clinically significant labs greater than Grade 2 on the NIH Division of AIDs Table for Grading the Severity of Adult and Pediatric Adverse events
Who the study is looking for
- 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.
- 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)
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
Related publications
- Single-Dose Longitudinal Pharmacokinetic Evaluation of Doravirine in Pregnant Women Living With HIV: Protocol for a Phase 1 Study.JMIR Res Protoc · 2026 · PMID 42429665
This page is information, not medical advice. Discuss any trial with your doctor.