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Actively Recruiting

Phase 4
Age: 60Years +
All Genders
ID06646562

Study of Long-Acting Cabotegravir Plus Rilpivirine for People Living with HIV-1 Aged 60 Years and Older Over 24 Months

Led by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Updated on 2025-03-11

120

Participants Needed

8

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of long-acting Cabotegravir plus Rilpivirine treatment in people living with HIV-1 who are aged 60 years or older. This study aims to compare the treatment results in this older population to those seen in younger patients. It also explores possible improvements in metabolic and liver health, as well as considers psychosocial factors such as stigma and psychological disorders that may affect older patients living with HIV. Participants will receive Cabotegravir 600 mg and Rilpivirine 900 mg injections into the muscle every two months after an initial induction phase with doses at months 1 and 2. The study focuses on patients who are stable on oral antiretroviral therapy ART and evaluates the switch to the long-acting injectable regimen over a 24-month period. During the study, participants will be regularly monitored for viral load levels, immune response, and any confirmed virologic failures. The research team will also track safety events related to the treatment. The primary outcome measured is the number of patients maintaining plasma HIV-1 RNA levels at or below 50 copiesmL after switching treatments at 12 months, with additional assessments conducted at 6, 12, and 24 months to monitor ongoing viral control and safety.

CONDITIONS

Brief Title

Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months.

Research Team

E

Enrique Bernal Morell Jefe de Servicio de Medicina Interna. Hospital General Univer, MD

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