Small study tests HIV drug dosing in pregnant women
NCT ID NCT04900974
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how pregnancy changes the levels of the HIV drug doravirine in the blood. Seven pregnant women living with HIV took a single dose of doravirine during their second and third trimesters, and again after giving birth. The goal was to find the right dose for pregnant women to keep the drug effective and safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
7 people
The number who actually took part.
- Started
-
Jun 2022
- Finished
-
Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HIV infections are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Three-Session couples program cut drug use and HIV risk?
- Decades of HIV data could reveal which treatments last
- Can testing together again keep male couples HIV-Free?
- Can a rapid HIV test get people treated sooner?
- Can Same-Day HIV prevention reach people before infection takes hold?
- New injectable HIV prevention drug tested in healthy volunteers