Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134362
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-11-10
Brief Title:
Long-term Follow-up of Long-acting Cabotegravir CAB LA for PrEP Pre-exposure Prophylaxis in Participants at Risk of Acquiring HIV Human Immunodeficiency Virus
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Phase IIIB Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
PALISADE
Brief Summary:
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir CAB LA for HIV pre-exposure prophylaxis PrEP in eligible participants who have completed DAIDS Division of AIDS sponsored studies HPTN 083 and HPTN 084 and associated sub-studies Participants will continue receiving CAB LA and be followed for new HIV diagnosis SAEs serious adverse events Grade 3 and Grade 4 ISRs injection site reactions and AEs adverse events leading to withdrawal
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?:
None