Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900974
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-05-13
Brief Title:
Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Antiretroviral ARV medications are used to treat infection with human immunodeficiency virus HIV During pregnancy ARV therapy keeps women healthy and decreases the spread of HIV to their babies 1-2
Many changes occur in the body during pregnancy which can alter the concentrations of drug in the body Doravirine DOR is a Food and Drug Administration FDA approved ARV but the extent to which the drug concentrations of doravirine change during pregnancy is unknown Because these changes are unknown DOR has not been approved by the FDA for use among pregnant women however the FDA has given the researchers permission to use it in this study Pregnant women are often excluded from clinical trials so it can take several years after a drug gets approved before contemporary ARV is available to them
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
Many changes occur in the body during pregnancy which can alter the concentrations of drug in the body Doravirine DOR is a Food and Drug Administration FDA approved ARV but the extent to which the drug concentrations of doravirine change during pregnancy is unknown Because these changes are unknown DOR has not been approved by the FDA for use among pregnant women however the FDA has given the researchers permission to use it in this study Pregnant women are often excluded from clinical trials so it can take several years after a drug gets approved before contemporary ARV is available to them
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None