Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months. (LOVER60)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV-1 Infected Adults with Controlled Viremia
• Intervention / Treatment: Drug: Cabotegravir LA + Rilpivirine LA

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Enrique Bernal Morell Jefe de Servicio de Medicina Interna. Hospital General Univer, MD; Phone Number: 968 35 90 00; Email: ebm.hgurs@gmail.com

Study Locations

• Spain
  • Murcia, Spain, 30003
    • Recruiting
    • Hospital General Universitario Reina Sofia
    • Contact: Enrique Bernal Morel, MD; Email: ebm.hgurs@gmail.com
  • Murcia, Spain, 30008
    • Not yet recruiting
    • Hospital General Universitario Morales Meseguer
    • Contact: Joaquín Bravo Urbieta, MD; Phone Number: 968 36 09 00; Email: jokinbravo@hotmail.com
  • Murcia, Spain, 30100
    • Not yet recruiting
    • Hospital Clinico Universitario Virgen de la Arrixaca Murcia
    • Contact: Carlos Galera, MD; Phone Number: 968369500; Email: carlosgalerap@gmail.com
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Not yet recruiting
      • Hospital General Universitario de Elche
      • Contact: Mar Masiá Canuto, MD; Phone Number: 966 61 69 00; Email: marmasiac@gmail.com
    • Villajoyosa, Alicante, Spain, 03570
      • Not yet recruiting
      • Hospital Marina Baixa
      • Contact: María Inmaculada Concepción Amador, MD; Phone Number: 966 90 72 00; Email: concha.amador@gmail.com
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • Not yet recruiting
      • Hospital General Universitario Santa Lucía
      • Contact: Francisco Jesús Vera Méndez, MD; Phone Number: 968 12 86 00; Email: franciscovera72@gmail.com
    • Lorca, Murcia, Spain, 30813
      • Not yet recruiting
      • Hospital Universitario Rafael Mendéz de Lorca
      • Contact: Ana Isabel Peláez Ballesta, MD; Phone Number: 968 44 55 00; Email: anapelaezballesta@gmail.com
    • Pozo Aledo, Murcia, Spain, 30739
      • Not yet recruiting
      • Hospital General Universitario Los Arcos del Mar Menor
      • Contact: Diana Piñar Cabezos, MD; Phone Number: 968 56 50 00; Email: dianapinar@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAB LA + RPV LA; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of HIV-1 RNA Copies	To evaluate other estimations of virological control and number of episodes of plasma HIV-1 RNA ≥50 copies/mL that do not meet the criteria for confirmed virological failure	6, 12 and 24 Months
Levels of HIV-1 RNA Copies (plasma HIV-1 RNA ≥200 copies/mL)	To determine the proportion of participants experiencing confirmed virologic failure	12 and 24 Months
Number of Participants with experienced CVF (confirmed virologic failure)	To asses treatment emergent genotypic and phenotypic resistance in participants experiencing CVF. Levels of hiv-1 RNA copies	6, 12 and 24 Months
To evaluate the immune effects of switching to CAB LA + RPV LA	Plasma levels of (CD4 and CD4/CD8),	6, 12 and 24 Months
Number of SAES/SUSAR in patients treated with CAB LA + RPV LA	evaluation of parameters ensuring efficacy and security of patients, Number of SAES/SUSAR	6, 12 and 24 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4/CD8 ratio	To assess the change in CD4/CD8 ratio	6, 12 and 24 Months
HIV Status	Questionnaire status version (HIVTSQs),	6, 12 and 24 Months
HIV Treatment Satisfaction	Perception of injection questionnaire (PIN)	6, 12 and 24 Months

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Collaborators: ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Virus Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Viremia; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Rilpivirine; Cabotegravir
• Other Study ID Numbers: IMIB-LOVER60-2022-03; 2022-502882-53-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No