A Phase 4 interventional study of Cabotegravir LA + Rilpivirine LA in HIV-1 Infected Adults With Controlled Viremia, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Active, not recruiting at 8 sites in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Phase 4, Interventional, and Treatment
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.
57 studies on the registry are indexed under Viremia; 12 are open to participants now.
This study's planned enrollment of 120 is above the median of 87 across 45 interventional studies indexed under Viremia.
Browse Viremia studies →Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia is the lead sponsor of 43 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Up to 12 Months
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
Time frame: 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
Time frame: 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
Time frame: 6, 12 and 24 Months
To evaluate the immune effects of switching to CAB LA + RPV LA
Plasma levels of (CD4 and CD4/CD8),
Time frame: 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
Time frame: 6, 12 and 24 Months
CD4/CD8 ratio
To assess the change in CD4/CD8 ratio
Time frame: 6, 12 and 24 Months
HIV Status
Questionnaire status version (HIVTSQs),
Time frame: 6, 12 and 24 Months
HIV Treatment Satisfaction
Perception of injection questionnaire (PIN)
Time frame: 6, 12 and 24 Months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia