Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862975
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2021-04-23
Brief Title:
Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana
Status:
RECRUITING
Status Verified Date:
2024-02
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:
BMS02
Brief Summary:
The purpose of this study is to characterize the pharmacokinetics PK of understudied drugs administered to lactating women receiving antiretroviral drugs per SOC as prescribed by their healthcare provider and their co-enrolled infants 180 days of age who receive maternal breastmilk
Detailed Description:
Prospective single-site open label PK and safety study Co-enrollment of lactating women 18 years of age receiving drugs of interest DOIs per standard of care SOC as prescribed by their healthcare providers and their infants who receive maternal breastmilk 180 days postpartum
To understand drug transfer into breastmilk and determine subsequent infant exposure biological samples will be collected from lactating women blood and breastmilk and infants blood The opportunistic design of this study will allow for a minimal risk study an expanded enrollment net evaluation of antiretroviral drugs and capitalization of procedures performed per SOC to maximize study efficiency and data collection and minimize potential risk to participants The data collected through this initiative will provide valuable PK dosing and safety information for drugs in this vulnerable population in order to inform public health
To understand drug transfer into breastmilk and determine subsequent infant exposure biological samples will be collected from lactating women blood and breastmilk and infants blood The opportunistic design of this study will allow for a minimal risk study an expanded enrollment net evaluation of antiretroviral drugs and capitalization of procedures performed per SOC to maximize study efficiency and data collection and minimize potential risk to participants The data collected through this initiative will provide valuable PK dosing and safety information for drugs in this vulnerable population in order to inform public health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN275201800003I | OTHER_GRANT | NICHD | None |