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

NCT05601128 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-06-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-04-01
Completion
2025-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05601128 on ClinicalTrials.gov