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COMPLETED
NCT04900974
PHASE1

Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2022-06-09

Completion Date

2025-04-08

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

DRUG

Doravirine

100mg

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States