Long-acting HIV treatment for older adults

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

This study is testing if a long-acting HIV treatment is safe and effective for adults aged 60 and older who have their virus under control.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (Academic / other)
• Locations: 8 sites (Elche, Alicante and 7 other locations)
• Trial ID: NCT06646562 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of long-acting Cabotegravir and Rilpivirine in adults aged 60 and older living with HIV-1 who have controlled viremia. It aims to determine if the treatment is as effective for this older population as it is for younger individuals. Additionally, the study will monitor metabolic and hepatic parameters to assess potential improvements, considering that older patients may have more comorbidities. Psychosocial factors will also be examined due to the stigma and psychological challenges faced by this demographic.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60 and older with controlled HIV-1 viremia and no history of viral resistance to the treatment agents.

Not a fit: Patients with active substance use disorders, acute major organ diseases, or those who have had recent viral loads above the threshold will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide older adults living with HIV-1 a more effective and convenient long-term management option.

How similar studies have performed: Other studies have shown promising results with long-acting antiretroviral therapies, but this specific focus on older adults is relatively novel.

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

Where this trial is running

Elche, Alicante and 7 other locations

• Hospital General Universitario de Elche — Elche, Alicante, Spain (Not_yet_recruiting)
• Hospital Marina Baixa — Villajoyosa, Alicante, Spain (Not_yet_recruiting)
• Hospital General Universitario Santa Lucía — Cartagena, Murcia, Spain (Not_yet_recruiting)
• Hospital Universitario Rafael Mendéz de Lorca — Lorca, Murcia, Spain (Not_yet_recruiting)
• Hospital General Universitario Reina Sofia — Murcia, Murcia, Spain (Recruiting)
• Hospital General Universitario Morales Meseguer — Murcia, Murcia, Spain (Not_yet_recruiting)
• Hospital Clinico Universitario Virgen de la Arrixaca Murcia — Murcia, Murcia, Spain (Not_yet_recruiting)
• Hospital General Universitario Los Arcos del Mar Menor — Pozo-Aledo, Murcia, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Enrique Bernal Morell Jefe de Servicio de Medicina Interna. Hospital General Univer, MD

Conditions HIV-1 Infected Adults with Controlled Viremia