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

Launched by FUNDACION PARA LA FORMACION E INVESTIGACION SANITARIAS DE LA REGION DE MURCIA · Oct 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a long-acting treatment for HIV-1 in adults aged 60 and older. The treatment combines two medications, Cabotegravir (CAB) and Rilpivirine (RPV), which are given as injections. The goal is to see if this treatment works as well for older adults as it does for younger patients. The study also looks at how this treatment might improve health issues that older adults with HIV may face, such as problems with metabolism and liver health, as well as their overall well-being and social experiences.

To be eligible for the trial, participants must be able to follow the study requirements and have stable HIV levels, meaning their virus is well-controlled. They should have been on a consistent HIV treatment without any major issues like resistance to the medications. Women can participate if they are not pregnant or breastfeeding. Participants will receive the treatment and will be monitored closely over the 24-month period to assess its effectiveness and safety. Overall, this trial aims to ensure that older adults living with HIV can maintain their health and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be able to understand and comply with protocol requirements, instructions, and restrictions.
• • Understand the long-term commitment to the study and be likely to complete the study as planned.
• • Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.).
• • Must be on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class.
• • Plasma HIV-1 RNA \<50 copies/mL at screening.
• • A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test at screen and a negative urine hCG test at randomization) and not lactating
• Exclusion Criteria:
• • Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blips are allowed (increased viral load ≥50 copies/mL but \<200 copies/mL preceded and followed by a viral load less than 50 copies/mL)
• • Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
• • Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to NNRTI or INSTI (defined as a confirmed plasma HIV-1 RNA measurement ≥200 copies/mL after initial suppression to \<50 copies/mL while on first line HIV therapy regimen)
• • Subjects who are currently participating in or anticipate being selected for any other interventional study. Observational studies and intervention studies that do not include treatments are allowed unless they interfere with scheduled visits.
• • Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication