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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
Hospital General Universitario de Elche
Elche, Alicante, Spain
NOT_YET_RECRUITINGHospital Marina Baixa
Villajoyosa, Alicante, Spain
NOT_YET_RECRUITINGHospital General Universitario Santa Lucía
Cartagena, Murcia, Spain
NOT_YET_RECRUITINGHospital Universitario Rafael Mendéz de Lorca
Lorca, Murcia, Spain
NOT_YET_RECRUITINGHospital General Universitario Reina Sofia
Murcia, Murcia, Spain
RECRUITINGHospital General Universitario Morales Meseguer
Murcia, Murcia, Spain
NOT_YET_RECRUITINGHospital Clinico Universitario Virgen de la Arrixaca Murcia
Murcia, Murcia, Spain
NOT_YET_RECRUITINGHospital General Universitario Los Arcos del Mar Menor
Pozo-Aledo, Murcia, Spain
NOT_YET_RECRUITINGNumer 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
Enrique Bernal Morell Jefe de Servicio de Medicina Interna. Hospital General Univer, MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.