Actively Recruiting

Phase 4
Age: 60Years +
All Genders
NCT06646562

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

Led by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Updated on 2025-03-11

120

Participants Needed

8

Research Sites

99 weeks

Total Duration

On this page

Sponsors

F

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Lead Sponsor

V

ViiV Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and follow study instructions and requirements
  • Willing to commit to and complete the long-term study
  • Suitable candidates for oral and injectable HIV medications, with no active substance use disorder or major organ disease
  • On a stable antiretroviral regimen with no current or past viral resistance or failure to NNRTI and INI drugs
  • HIV-1 RNA levels below 50 copies/mL at screening
  • Female participants must not be pregnant or breastfeeding, confirmed by tests at screening and randomization
Not Eligible

You will not qualify if you...

  • HIV-1 RNA levels above 50 copies/mL within 6 months before screening, except short viral blips under 200 copies/mL
  • Any drug holiday longer than one month between starting first HIV treatment and 6 months before screening
  • Switching to second-line HIV treatment due to virologic failure to NNRTI or INSTI drugs
  • Currently participating or expected to participate in other interventional studies that interfere with this study
  • Receiving any prohibited medications and unable or unwilling to switch to allowed alternatives

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Hospital General Universitario de Elche

Elche, Alicante, Spain, 03203

Not Yet Recruiting

2

Hospital Marina Baixa

Villajoyosa, Alicante, Spain, 03570

Not Yet Recruiting

3

Hospital General Universitario Santa Lucía

Cartagena, Murcia, Spain, 30202

Not Yet Recruiting

4

Hospital Universitario Rafael Mendéz de Lorca

Lorca, Murcia, Spain, 30813

Not Yet Recruiting

5

Hospital General Universitario Reina Sofia

Murcia, Murcia, Spain, 30003

Actively Recruiting

6

Hospital General Universitario Morales Meseguer

Murcia, Murcia, Spain, 30008

Not Yet Recruiting

7

Hospital Clinico Universitario Virgen de la Arrixaca Murcia

Murcia, Murcia, Spain, 30100

Not Yet Recruiting

8

Hospital General Universitario Los Arcos del Mar Menor

Pozo-Aledo, Murcia, Spain, 30739

Not Yet Recruiting

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Research Team

E

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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