A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV
NCT Number: NCT06518408
Acronym: CABO-CHANCE
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Human Immunodeficiency Virus
Interventions: DRUG: Cabotegravir Injectable Product|DRUG: Rilpivirine Injectable Product
Sponsor: University Hospital Virgen de las Nieves
Collaborators: ViiV Healthcare
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 287
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-06-01
Completion Date: 2027-09-30
Locations: Hospital Universitario Virgen de Las Nieves, Granada, Andalucía, 18008, Spain|Hospital San Pedro, Logroño, La Rioja, 26006, Spain|Hospital Reina Sofía, Murcia, Región De Murcia, 30003, Spain|Hospital Universitario Puerto Real, INIBICA,, Cadiz, Spain|Jerez de la Frontera University Hospital, Cadiz, Spain|Reina Sofía University Hospital, Córdoba, Spain|Hospital Campus de la Salud, Granada, 18014, Spain|Hospital Comarcal Santa Ana de Motril, Granada, Spain|Complejo Hospitalario de Jaén,, Jaén, Spain|Hu La Princesa, Madrid, Spain|Ramon Y Cajal, Madrid, Spain|Hospital General Universitario Santa Lucía, Murcia, Spain|Hospital de Son Llàtzer, Palma De Mallorca, Spain|Hospital Universitario de Canarias, Tenerife, Spain|Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain

Summary:
The CABOTEGRAVIR Long Acting + RILPIVIRENE Long Acting regimen was currently endorsed by guidelines worldwide as an option for the Treatment of HIV-1 Infection, however collecting real-world data closer to clinical practice use is still necessary. This study also registers some immunological, metabolic,anti-inflammatory parameters and fat distribution analysis to observe a hypothetical improvement on these parameters.

Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffer certain psychological disorders. Patient experience data will be assessed through PROs and bespoke single-item questions to collect patient perception of treatment and register psychosocial aspects related to their health status.

Primary Outcome Measures: Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 12, Proportion of participants suppressed on stable oral ART that switched to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 12, 12 months
Secondary Outcome Measures: Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at month 24, Proportion of participants suppressed on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL at month 24, 24 months|Number of participants switching treatment to CAB LA + RPV LA regimen dosed every 2-months with plasma HIV-1 RNA ≥50 at months 12 and 24, Proportion of participants suppressed on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA \<50 copies/mL at months 12 and 24, 12 and 24 months|Number of episodes of plasma HIV-1 RNA ≥50 copies/mL, Number of episodes of plasma HIV-1 RNA ≥50 copies/mL that do not meet the criteria for confirmed virological failure, 24 months|Number of participants experiencing confirmed virologic failure at months 12 and 24., Proportion of participants experiencing confirmed virologic failure (CVF: two consecutive plasma HIV-1 RNA ≥200 copies/mL) at months 12 and 24., 12 and 24 months|Change from baseline in the mean lymphocyte subpopulations, Changes from baseline in the mean values of CD4, CD8 and CD4/CD8 ratio of participants switching to CAB LA + RPV LA at months 12 and 24., 12 and 24 months|Incidence and severity of adverse events, Proportion of emergence of adverse events, laboratory abnormalities and discontinuation rates due to adverse events. Includes severity evaluation of those, 24 months|Description of reasons for discontinuation from CAB LA + RPV LA over 24 months, Reasons recorded for discontinuation of the study intervention during the follow-up, 24 months|Number of reports fo adverse events over 24 months, Persistence over 24 months of adverse events, including injection site reactions (ISR), after switching to CAB LA + RPV LA, 24 months|Description of reasons for switching to CAB LA + RPV LA, Reasons recorded for switching to the study intervention, 24 months|Changes in absolute values from baseline over 24 months in metabolic control parameters: glucose, changes from baseline over 24 months and the proportion by patient subgroup with significant changes: in metabolic control parameters: glucose, 24 months|Changes in absolute values from baseline over 24 months in metabolic control parameters: lipids, changes from baseline over 24 months and the proportion by patient subgroup with significant changes: in metabolic control parameters: lipids., 24 months|Changes in absolute values from baseline over 24 months in metabolic control parameters: weight, changes from baseline over 24 months and the proportion by patient subgroup with significant changes: in metabolic control parameters: weight., 24 months|Changes in absolute values from baseline over 24 months in metabolic control parameters: waist circumference., changes from baseline over 24 months and the proportion by patient subgroup with significant changes: in metabolic control parameters: waist circumference., 24 months|Changes in absolute values from baseline over 24 months in metabolic control parameters: BMI, changes from baseline over 24 months and the proportion by patient subgroup with significant changes in metabolic control parameters: BMI (kg/m\^2)., 24 months|Changes in pro-inflammatory biomarkers (D-Dimmer) from baseline over 24 months in a subgroup of participants, Assesment and description in a subgroup of study participants of the change of pro-inflammatory biomarkers (D-Dimmer) after switching to CAB LA+ RPV LA through the study., 24 months|Changes in pro-inflammatory biomarkers (fibrinogen) from baseline over 24 months in a subgroup of participants, Assesment and description in a subgroup of study participants of the change of pro-inflammatory biomarkers (fibrinogen) after switching to CAB LA+ RPV LA through the study., 24 months|Changes in pro-inflammatory biomarkers (CRP) from baseline over 24 months in a subgroup of participants, Assesment and description in a subgroup of study participants of the change of pro-inflammatory biomarkers (CRP) after switching to CAB LA+ RPV LA through the study., 24 months|Changes in pro-inflammatory biomarkers (IL-6) from baseline over 24 months in a subgroup of participants, Assesment and description in a subgroup of study participants of the change of pro-inflammatory biomarkers (IL-6) after switching to CAB LA+ RPV LA through the study., 24 months|Changes in creatinine values from baseline over 24 months, Changes from baseline over 24 months in creatinine (mg/dL) values after switching to CAB LA + RPV LA, 24 months|Changes in hepatic values (Albumine) from baseline over 24 months, Changes from baseline over 24 months in hepatic values (Albumine) in g/dL after switching to CAB LA + RPV LA, 24 months|Changes in hepatic values (Alanine transaminase (ALT), Aspartate transaminase (AST) and Alkaline phosphatase (ALP)) from baseline over 24 months, Changes from baseline over 24 months in hepatic values (Alanine transaminase (ALT), Aspartate transaminase (AST) and Alkaline phosphatase (ALP)) in U/L after switching to CAB LA + RPV LA, 24 months|Changes in preference values from baseline over 24 months about ART, Rate of ART preference of LA-injected vs. oral ART at months12 and 24 and description of reasons, 12 and 24 months|Changes in patient reported outcomes questionnaires from baseline over 24 months: WHOQOL-HIV-BREF, Changes from baseline in domains of PROs: World Health Organization Quality of Life, on Human Immunodeficiency Virus, brief version (WHOQOL-HIV-BREF) scale over 24 months and the proportion by patient subgroup with significant changes. MIN VALUE 26- MAX VALUE 130. Higher scores mean better quality of life., 24 months|Changes in patient reported outcomes questionnaires from baseline over 24 months: HSSS, Changes from baseline in domains of PROs: adapted HIV Stigma Scale for use in Spain (HSSS) scale over 24 months and the proportion by patient subgroup with significant changes. Scores can range from 40 to 160 \[1 x 40 items to 4 x 40 items\]. Higher scores indicate greater feelings of stigma, 24 months|Changes in patient reported outcomes questionnaires from baseline over 24 months: PSQI, Changes from baseline in domains of PROs: Pittsburgh Sleep Quality Index (PSQI) scale over 24 months and the proportion by patient subgroup with significant changes. Score has a possible range of 0-21 points. Higher scores means better sleep quality, 24 months|Incidence of adherence to scheduled interventions over 24 months, * Number and percentage of total injections within ±7-day dosing window
* Number and percentage of missed injections., 24 months