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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 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 7 participants.
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.
Interventions
- DRUG Doravirine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2025-04-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04900974
The ClinicalTrials.gov registry entry for NCT04900974 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Doravirine is the first listed.
NCT04900974 reports 0 study locations.
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.
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