Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-02 @ 3:47 AM
Study NCT ID:
NCT06507059
Status:
RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
A Phase 3 Study Comparing Clinical Outcomes in People Living With HIV (PLHIV) With Suboptimal Adherence Treated With Injectable Long-acting Antiretrovirals Versus Oral Antiretrovirals
Status:
RECRUITING
Status Verified Date:
2024-07
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:
SUPLA
Brief Summary:
This study aims to determine whether people living with HIV (PLHIV) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (LA) compared to all-oral antiretrovirals.
Detailed Description:
This is an open-label, multi-center, randomized, active-controlled, superiority trial on 40 adult subjects who had been diagnosed to have HIV infection for at least 12 months before enrollment but with suboptimal viral suppression despite antiretroviral treatment (ART), with the latest HIV-1 viral load ≥ 200 copies/mL. Participants' eligibility will be assessed through a review of their medical records, and individuals with established resistance to cabotegravir or rilpivirine will be excluded. Enrolled participants will then be randomized 1:1 to either "Delayed Switch to LA Treatment Group" or "Immediate LA Treatment Group" on enrollment. The "Delayed Switch to LA Treatment Group" will also switch to LA on week 24. The proportion of participants with HIV-1 RNA \<200 copies/mL at week 24 in the two study groups will be compared. Psychologic assessments including self-stigma and depression assessment will also be performed on day1, at week 24 and week 52.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MOHW113-CDC-C-114-000106 | OTHER_GRANT | Taiwan Centers for Disease Control | View |