drugset / Trial / NCT06185452

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

NCT06185452

Phase 4 Completed 103 enrolled Fight AIDS and Infectious Diseases Foundation
RandomizedParallel-groupOpen-labelTreatment

Summary

HOLA is a prospective, randomized (1:1), hybrid type (implementation-effectiveness), phase IV, double arm, open label, multicentric study including virologically suppressed HIVinfected subjects who start or are currently under treatment with the LA antiretroviral combination CAB+RPV, to evaluate the out-of-hospital administration of this combination in terms of acceptability, appropriateness, feasibility and satisfaction.

Timeline

Start
2023-09-26
Primary completion
2025-05-30
Completion
2025-05-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cabotegravir Small molecule 600 mg
Comparator Rilpivirine Small molecule 900 mg