NCT05601128

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1-infection
• HIV Infections
• HIV I Infection

Interventions

Type	Name	Description
DRUG	CAB + RPV	At Day 1 all participants will initiate oral CAB 30 mg + RPV 25 mg once daily for at least 28 days during the Oral Phase. Participants will receive CAB LA 600 mg + RPV LA 900 mg IM injections at month 1 visit followed by CAB LA 400 mg + RPV LA 600 mg IM injections monthly at M2, M3, M4 and M5 visits. Then, starting at month 6 visit, participants will receive CAB LA 600 mg + RPV LA 900 mg IM injections every 2 months at M6, M8, M10 and M12.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-04-01
• Completion: 2025-05-01
• First posted: 2022-11-01
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study