Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507059
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
Sponsor:
None
Organization:
None
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:
No
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 copiesmL 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 11 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 copiesmL 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None