Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-29 @ 2:06 AM
Study NCT ID:
NCT07275606
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
Sponsor:
ViiV Healthcare
Organization:
Study Overview
Official Title:
A Phase 1/2 Study of the Safety, Tolerability, and Pharmacokinetics of Cabotegravir in Neonates Exposed to HIV-1
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
CABNATE
Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: