NCT06694805

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	CAB LA + RPV LA	Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.
DRUG	Oral ART	Oral medication provided to participants by the site/their regular healthcare professional (HCP) as part of their standard of care (SOC) treatment.

Timeline

• Start date: 2024-12-02
• Primary completion: 2026-08-31
• Completion: 2028-06-19
• First posted: 2024-11-19
• Last updated: 2026-03-09

Locations

89 sites across 9 countries: United States, Argentina, Belgium, Canada, Germany, Italy, Portugal, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study