Actively Recruiting
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
Eligibility Criteria
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
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
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
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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