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NCT04900974 · ClinicalTrials.gov registry record · Phase 1
Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT04900974: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT04900974 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04900974, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Doravirine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2025-04-08 |
| Phase | Phase 1 |
What the finished NCT04900974 record still lists
NCT04900974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Doravirine is the first listed.
NCT04900974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04900974 about?
NCT04900974 is a clinical study titled "Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women". 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 prescribe...
What is the current status of trial NCT04900974?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2022-06-09. Estimated completion is 2025-04-08.
What interventions are being tested in trial NCT04900974?
The interventions under investigation include: Doravirine (DRUG).
Who is sponsoring clinical trial NCT04900974?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04900974's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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