At a glance
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Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
In Brief
A Phase 1 clinical trial evaluating Doravirine for HIV Infections and Pregnancy Related. Completed, enrolled 7 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
100mg