At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating CAB OLI, CAB LA, and 3 other interventions for HIV Infections. Completed, enrolled 437 participants across 18 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
CAB LA 600 mg will be administered as intramuscular (IM) injection.
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.
RPV LA 900 mg will be administered as IM injection.
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.