NCT06518408

A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 287 (actual)
• Sponsor: University Hospital Virgen de las Nieves · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CABOTEGRAVIR Long Acting + RILPIVIRENE Long Acting regimen was currently endorsed by guidelines worldwide as an option for the Treatment of HIV-1 Infection, however collecting real-world data closer to clinical practice use is still necessary. This study also registers some immunological, metabolic,anti-inflammatory parameters and fat distribution analysis to observe a hypothetical improvement on these parameters. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffer certain psychological disorders. Patient experience data will be assessed through PROs and bespoke single-item questions to collect patient perception of treatment and register psychosocial aspects related to their health status.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Cabotegravir Injectable Product	long-acting regimen dosed every 2-months
DRUG	Rilpivirine Injectable Product	long-acting regimen dosed every 2-months

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-04-30
• Completion: 2027-09-30
• First posted: 2024-07-24
• Last updated: 2024-07-24

Locations

15 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study