Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 9:45 AM
Study NCT ID:
NCT06336434
Status:
WITHDRAWN
Last Update Posted:
2025-07-31
First Post:
2024-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Phase I/II Study of the Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Adults With HIV-1
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to shifting priorities and reduced funding, the IMPAACT Network is not able to continue efforts toward opening IMPAACT 2040.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.
Detailed Description:
None
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?: