Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 11:01 AM
Study NCT ID:
NCT05601128
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2022-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA
Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Organization:
Study Overview
Official Title:
An Open-label Study Evaluating the Pharmacokinetics (PK), Efficacy, Safety, and Tolerability of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) Intramuscular (IM) Administered Monthly and Every 2 Months in Virologically Suppressed HIV-1-Infected Adults With Severe Renal Impairment With or Without Hemodialysis (CAPRI)
Status:
COMPLETED
Status Verified Date:
2025-06
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:
CAPRI
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of CABENUVA (Long-acting Cabotegravir Plus Long-acting Rilpivirine) in patients with HIV infection and severe renal impairment. This study is considered research and is voluntary.
Detailed Description:
The purpose of this study is to evaluate CABENUVA (Long-acting Cabotegravir (CAB) Plus Long-acting Rilpivirine (RPV)) pharmacokinetics (movement of drugs within the body), safety and control of HIV in participants with renal (kidney) disease compared to historical values observed in those with normal renal function. Giving these drugs as an injection in your muscle (intramuscular) may offer be better tolerated by the body and may be simpler than taking a regular oral medication.
Researchers want to find out if two drugs long-acting CABENUVA can help people with HIV and kidney disease when given every 8 weeks (2 months) or every 4 weeks (monthly). 12 patients will be enrolled into this study between two study sites.
For the purposes of this project, we have applied for and received an FDA IND exemption (IND #161158) as this is a pilot study and not intended to result in a change in product labeling.
Researchers want to find out if two drugs long-acting CABENUVA can help people with HIV and kidney disease when given every 8 weeks (2 months) or every 4 weeks (monthly). 12 patients will be enrolled into this study between two study sites.
For the purposes of this project, we have applied for and received an FDA IND exemption (IND #161158) as this is a pilot study and not intended to result in a change in product labeling.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: