Long Acting Cabotegravir Plus Rilpivirine in People Living With HIV-1 Aged ≥ 60 Years for 24 Months. (LOVER60)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Alicante
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Elche, Alicante, España, 03203
- Hospital General Universitario de Elche
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Villajoyosa, Alicante, España, 03570
- Hospital Marina Baixa
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Murcia
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Cartagena, Murcia, España, 30202
- Hospital General Universitario Santa Lucía
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Lorca, Murcia, España, 30813
- Hospital Universitario Rafael Mendéz de Lorca
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Murcia, Murcia, España, 30008
- Hospital General Universitario Morales Meseguer
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Murcia, Murcia, España, 30003
- Hospital General Universitario Reina Sofia
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Murcia, Murcia, España, 30100
- Hospital Clinico Universitario Virgen de la Arrixaca Murcia
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Pozo-Aledo, Murcia, España, 30739
- Hospital General Universitario Los Arcos del Mar Menor
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Be able to understand and comply with protocol requirements, instructions, and restrictions.
- Understand the long-term commitment to the study and be likely to complete the study as planned.
- Be considered appropriate candidates for participation in an investigative clinical trial with oral and intramuscularly injectable medications (e.g., no active substance use disorder, acute major organ disease, or planned long-term work assignments out of the country, etc.).
- Must be on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class.
- Plasma HIV-1 RNA <50 copies/mL at screening.
- A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test at screen and a negative urine hCG test at randomization) and not lactating
Exclusion Criteria:
- Plasma HIV-1 RNA measurement ≥50 copies/mL within 6 months prior to screening. Blips are allowed (increased viral load ≥50 copies/mL but <200 copies/mL preceded and followed by a viral load less than 50 copies/mL)
- Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
- Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to NNRTI or INSTI (defined as a confirmed plasma HIV-1 RNA measurement ≥200 copies/mL after initial suppression to <50 copies/mL while on first line HIV therapy regimen)
- Subjects who are currently participating in or anticipate being selected for any other interventional study. Observational studies and intervention studies that do not include treatments are allowed unless they interfere with scheduled visits.
- Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: CAB LA + RPV LA
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 |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numer of patients on stable oral ART that switch to CAB LA + RPV LA with plasma HIV-1 RNA ≥50 copies/mL
Periodo de tiempo: Up to 12 Months
|
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. |
Up to 12 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Levels of HIV-1 RNA Copies
Periodo de tiempo: 6, 12 and 24 Months
|
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 |
6, 12 and 24 Months
|
|
Levels of HIV-1 RNA Copies (plasma HIV-1 RNA ≥200 copies/mL)
Periodo de tiempo: 12 and 24 Months
|
To determine the proportion of participants experiencing confirmed virologic failure |
12 and 24 Months
|
|
Number of Participants with experienced CVF (confirmed virologic failure)
Periodo de tiempo: 6, 12 and 24 Months
|
To asses treatment emergent genotypic and phenotypic resistance in participants experiencing CVF. Levels of hiv-1 RNA copies |
6, 12 and 24 Months
|
|
To evaluate the immune effects of switching to CAB LA + RPV LA
Periodo de tiempo: 6, 12 and 24 Months
|
Plasma levels of (CD4 and CD4/CD8), |
6, 12 and 24 Months
|
|
Number of SAES/SUSAR in patients treated with CAB LA + RPV LA
Periodo de tiempo: 6, 12 and 24 Months
|
evaluation of parameters ensuring efficacy and security of patients, Number of SAES/SUSAR |
6, 12 and 24 Months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
CD4/CD8 ratio
Periodo de tiempo: 6, 12 and 24 Months
|
To assess the change in CD4/CD8 ratio |
6, 12 and 24 Months
|
|
HIV Status
Periodo de tiempo: 6, 12 and 24 Months
|
Questionnaire status version (HIVTSQs), |
6, 12 and 24 Months
|
|
HIV Treatment Satisfaction
Periodo de tiempo: 6, 12 and 24 Months
|
Perception of injection questionnaire (PIN) |
6, 12 and 24 Months
|
Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IMIB-LOVER60-2022-03
- 2022-502882-53-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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