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

Last updated: March 6, 2025
Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Cabotegravir LA + Rilpivirine LA

Clinical Study ID

NCT06646562
IMIB-LOVER60-2022-03
2022-502882-53-00
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be able to understand and comply with protocol requirements, instructions, andrestrictions.

  • Understand the long-term commitment to the study and be likely to complete the studyas planned.

  • Be considered appropriate candidates for participation in an investigative clinicaltrial with oral and intramuscularly injectable medications (e.g., no activesubstance use disorder, acute major organ disease, or planned long-term workassignments out of the country, etc.).

  • Must be on a stable antiretroviral regimen without present or past evidence of viralresistance to, and no prior virological failure with agents of the NNRTI and INIclass.

  • Plasma HIV-1 RNA <50 copies/mL at screening.

  • A female subject is eligible to participate if she is not pregnant (as confirmed bya negative serum hCG test at screen and a negative urine hCG test at randomization)and not lactating

Exclusion

Exclusion Criteria:

  • Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blipsare allowed (increased viral load ≥50 copies/mL but <200 copies/mL preceded andfollowed by a viral load less than 50 copies/mL)

  • Any drug holiday during the window between initiating first HIV ART and 6 monthsprior to screening, except for brief periods (less than 1 month) where all ART wasstopped due to tolerability and/or safety concerns.

  • Any switch to a second line regimen, defined as change of a single drug or multipledrugs simultaneously, due to virologic failure to NNRTI or INSTI (defined as aconfirmed 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 anyother interventional study. Observational studies and intervention studies that donot include treatments are allowed unless they interfere with scheduled visits.

  • Participants receiving any prohibited medication and who are unwilling or unable toswitch to an alternative medication

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Cabotegravir LA + Rilpivirine LA
Phase: 4
Study Start date:
March 03, 2025
Estimated Completion Date:
January 30, 2027

Connect with a study center

  • Hospital General Universitario de Elche

    Elche, Alicante 03203
    Spain

    Site Not Available

  • Hospital Marina Baixa

    Villajoyosa, Alicante 03570
    Spain

    Site Not Available

  • Hospital General Universitario Santa Lucía

    Cartagena, Murcia 30202
    Spain

    Site Not Available

  • Hospital Universitario Rafael Mendéz de Lorca

    Lorca, Murcia 30813
    Spain

    Site Not Available

  • Hospital General Universitario Los Arcos del Mar Menor

    Pozo Aledo, Murcia 30739
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Arrixaca Murcia

    Murcia, 30100
    Spain

    Site Not Available

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008
    Spain

    Site Not Available

  • Hospital General Universitario Reina Sofia

    Murcia, 30003
    Spain

    Active - Recruiting

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