NCT04399551

A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

A Phase IIIb, Open-label, Hybrid Type III Trial Evaluating Implementation Strategies for Long-acting Cabotegravir Plus Long-acting Rilpivirine Every Two Months in HIV-1 Infected, Virologically Suppressed Adults in Select European Healthcare Settings

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 437 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience, compliance and improved quality of life for people living with HIV compared to current standard of care. This interventional study will examine different implementation strategies in different clinic settings across European countries to identify strategies which best meet the needs in each local context and involve both participants receiving study treatment CAB LA + RPV LA (patient study participants \[PSP\]) as well as the healthcare providers at the investigator site level (staff study participants \[SSP\]). SSPs consists of 2 groups: standard and enhanced arm.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	CAB OLI	CAB will be available as 30 milligrams (mg) tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
DRUG	CAB LA	CAB LA 600 mg will be administered as intramuscular (IM) injection.
DRUG	RPV OLI	RPV will be available as 25 mg tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
DRUG	RPV LA	RPV LA 900 mg will be administered as IM injection.
OTHER	Continuous Quality Improvement (CQI) calls	CQI will be attended by the enhanced arm (Arm-E). The CQI calls will be conducted to identify problems/challenges, generate plans to address the challenges, and identify how to measure the change that results from the plan.

Timeline

• Start date: 2020-09-28
• Primary completion: 2022-03-07
• Completion: 2023-03-13
• First posted: 2020-05-22
• Last updated: 2024-04-05
• Results posted: 2023-05-19

Locations

18 sites across 5 countries: Belgium, France, Germany, Netherlands, Spain

Regulatory

• FDA-regulated drug study