Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 4:56 AM
Study NCT ID:
NCT06159894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2023-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units".
Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Organization:
Study Overview
Official Title:
Implementation of Long-acting Cabotegravir + Rilpivirine Administration Out of "HIV Units".
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
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:
IMAdART
Brief Summary:
This is a clinical trial whose main purpose is to evaluate the acceptability of the administration of LA CAB + extended-release RPV as perceived by patients in month 12 in multipurpose day hospital units versus specialized care centers (HIV Units). . Candidates to participate in this study are indicated to receive this medication, so the decision to include the participant in the study will be after the decision to prescribe the drug. These patients will be randomly assigned to one location or another to receive the administration of the medication. Therefore, and after consulting with the AEMPS, it is considered that this is a clinical trial WITHOUT medications. Both the medication and the procedures associated with the follow-up of the participants will follow the usual practice for this type of patient, with the exception of completing the questionnaires aimed at evaluating the primary and secondary objectives of this study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: