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NCT06646562 | NOT YET RECRUITING | HIV-1 Infected Adults with Controlled Viremia

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

Foundation for Health Training and Research of the Region of Murcia

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.

Condition or disease

HIV-1 Infected Adults with Controlled Viremia

Intervention/treatment

Cabotegravir LA + Rilpivirine LA

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24
Actual Study Start Date : 2025-01-30
Estimated Primary Completion Date : 2026-01-30
Estimated Study Completion Date : 2027-01-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24

Location Details

NCT06646562

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Spain, Alicante

General University Hospital of Elche

Elche, Alicante, Spain, 03203

Not yet recruiting

Spain, Alicante

Marina Baixa Hospital

Villajoyosa, Alicante, Spain, 03570

Not yet recruiting

Spain, Murcia

Santa Lucía University General Hospital

Cartagena, Murcia, Spain, 30202

Not yet recruiting

Spain, Murcia

Rafael Mendéz University Hospital of Lorca

Lorca, Murcia, Spain, 30813

Not yet recruiting

Spain, Murcia

Los Arcos del Mar Menor General University Hospital

Aledo Well, Murcia, Spain, 30739

Not yet recruiting

Spain,

Reina Sofia University General Hospital

Murcia, Spain, 30003

Not yet recruiting

Spain,

Morales Meseguer General University Hospital

Murcia, Spain, 30008

Not yet recruiting

Spain,

Virgen de la Arrixaca University Clinical Hospital Murcia

Murcia, Spain, 30100