Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185452
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-09-22
Brief Title:
Implementation of Out-of-HOspital Administration of the Long-Acting CabotegravirRilpivirine
Sponsor:
Fundación FLS de Lucha Contra el Sida las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Organization:
Fundación FLS de Lucha Contra el Sida las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study Overview
Official Title:
Implementation of Out-of-HOspital Administration of the Long-Acting Combination CabotegravirRilpivirine as an Optional Therapy in HIV-Infected Patients From Spain Acceptability Appropriateness Feasibility and Satisfaction The HOLA Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOLA
Brief Summary:
HOLA is a prospective randomized 11 hybrid type implementation-effectiveness phase IV double arm open label multicentric study including virologically suppressed HIVinfected subjects who start or are currently under treatment with the LA antiretroviral combination CABRPV to evaluate the out-of-hospital administration of this combination in terms of acceptability appropriateness feasibility and satisfaction
Detailed Description:
Randomized patients will receive Long Acting LA cabotegravir CAB rilpivirine RPV administration in the hospital standard of care or out-of-hospital administration every 2 months M2 M4 M6 M8M10 M12 Medical visits routinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline M1 if patient has not previously receiving LA CABRPV M6 and M12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None