Comparing Cabotegravir Ultra Long-Acting Plus Rilpivirine Ultra Long-Acting Versus Long-Acting Cabotegravir and Rilpivirine in Teens and Adults With Controlled HIV

What this Trial Is About

Researchers are comparing two forms of long-acting drugs, cabotegravir ultra long-acting CAB ULA plus rilpivirine ultra long-acting RPV ULA versus cabotegravir long-acting CAB LA plus rilpivirine long-acting RPV LA, in adults and adolescents who have HIV and are already virologically suppressed on antiretroviral therapy ART. The study aims to evaluate the effectiveness, safety, and tolerability of these treatments in maintaining viral suppression. Participants are randomly assigned to receive either the CAB ULA plus RPV ULA combination or the CAB LA plus RPV LA combination. Both interventions involve administering these drugs as long-acting injectable treatments. The study is conducted as a phase III trial with parallel groups, where participants continue their assigned treatment regimen throughout the study period. During the trial, participants are monitored regularly to assess their HIV viral load, specifically tracking the percentage of participants with plasma HIV-RNA levels at or above 50 copiesmL at month 11. Additional measures include evaluating virologic failure, drug-related adverse events, and resistance to the study drugs up to month 23. Researchers also track immune cell counts and drug concentrations over time. The total duration of participation extends through to the study completion date, with ongoing safety and efficacy assessments.

A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed