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

NCT06646562 | Recruiting Phase 4

• 2 other identifiers: IMIB-LOVER60-2022-032022-502882-53-00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

Brief Summary

People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients. This study also registers some metabolic and hepatic parameters to observe a hypothetical improvement on these parameters, as the population may suffer more comorbidities than younger population and therefore tolerability and convenience gains a huge importance on them. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffering certain psychological disorders.

Conditions

HIV-1 Infected Adults with Controlled Viremia

Outcome Measures

Primary Outcomes (1)

• Numer of patients on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL

  Proportion of participants ≥60 years on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12 in the intention-to-treat exposed (ITT-E) population, per the FDA Snapshot algorithm.

  Up to 12 Months

Secondary Outcomes (5)

• Levels of HIV-1 RNA Copies

  6, 12 and 24 Months

• Levels of HIV-1 RNA Copies (plasma HIV-1 RNA ≥200 copies/mL)

  12 and 24 Months

• Number of Participants with experienced CVF (confirmed virologic failure)

  6, 12 and 24 Months

• To evaluate the immune effects of switching to CAB LA + RPV LA

  6, 12 and 24 Months

• Number of SAES/SUSAR in patients treated with CAB LA + RPV LA

  6, 12 and 24 Months

Other Outcomes (3)

• CD4/CD8 ratio

  6, 12 and 24 Months

• HIV Status

  6, 12 and 24 Months

• HIV Treatment Satisfaction

  6, 12 and 24 Months

Study Arms (1)

CAB LA + RPV LA

EXPERIMENTAL

the proportion of participants ≥60 years on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12 in the intention-to- treat exposed (ITT-E) population

Drug: Cabotegravir LA + Rilpivirine LA

Interventions

Cabotegravir LA + Rilpivirine LA DRUG

Cabotegravir (CAB) LA 600mg and Rilpivirine (RPV) LA 900mg will be administered intramuscularly every 2 months after an induction phase with a single administration in months 1 and 2.

CAB LA + RPV LA

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead
• ViiV Healthcare: collaborator

Study Sites (8)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

NOT YET RECRUITING

Hospital Marina Baixa

Villajoyosa, Alicante, 03570, Spain

NOT YET RECRUITING

Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

NOT YET RECRUITING

Hospital Universitario Rafael Mendéz de Lorca

Lorca, Murcia, 30813, Spain

NOT YET RECRUITING

Hospital General Universitario Reina Sofia

Murcia, Murcia, 30003, Spain

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Murcia, 30008, Spain

NOT YET RECRUITING

Hospital Clinico Universitario Virgen de la Arrixaca Murcia

Murcia, Murcia, 30100, Spain

NOT YET RECRUITING

Hospital General Universitario Los Arcos del Mar Menor

Pozo-Aledo, Murcia, 30739, Spain

NOT YET RECRUITING

Central Study Contacts

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

CONTACT

968 35 90 00; ebm.hgurs@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase IV study, prospective, open-label, single arm, multicentre, with a follow-up of 24 months

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: March 3, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)