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A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA — CAPRI  

HIV Infections Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05601128
Study type Interventional
Source Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 1, 2023
Completion date December 31, 2025
View Details
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