Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393387
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-04-26
Brief Title:
Retrospective Review of DTG3TC Versus BICFTAF Across a Multi Clinic Infectious Disease Organization in Southeast United States
Sponsor:
Midway Specialty Care Center
Organization:
Midway Specialty Care Center
Study Overview
Official Title:
Retrospective Review of DTG3TC Versus BICFTAF Across a Multi Clinic Infectious Disease Organization in Southeast United States REVIVE Study
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:
None
Brief Summary:
This real-world retrospective study describes the clinical efficacy of 2DR DOVATO DTG3TC versus 3DR BIKTARVY BICFTAF in PWH including those with at least 2 social determinants of health indicators across a multi clinic infectious disease organization in the Southeast United States
Detailed Description:
3-drug regimens 3DR have been the foundation of HIV treatment for the last two decades however based on more recent data from GEMINI 1 and 2 TANGO SALSA and STAT clinical trials 2-drug regimens 2DR such as dolutegravirlamivudine have shown similar efficacy in viral suppression as compared to 3DR1256 Furthermore real-world evidence RWE data has reinforced the clinical trial data showing similar effectiveness outcomes data of DTG3TC vs 3DR across 38000 people living with HIV in a variety of sub-populations including more than 1200 who are ART naïve Test and treat strategies have also been successful with both 2DR and 3DR3 but analysis of clinical outcomes including barriers to resistance as evidenced by viral suppression in persons with more challenging to treat HIV PWH are needed including PWH with social determinant of health SDOH indicators including but not limited to unstable housing food insecurity unemployment uninsured andor unstable transportation PWH may prioritize addressing these needs over adherence to antiretroviral therapy and lower adherence to antiretroviral therapy raises the concern for lack of viral suppression andor the development of resistance
A recent study demonstrated that PWH in the United States with 2 or more SDOH indicators were 20 less likely to report excellent adherence in the prior 30 days and 10 less likely to achieve sustained viral suppression in the prior year4 Furthermore as HIV disproportionately affects persons of lower socioeconomic status who are experiencing multiple SDOH indicators identifying ART that can be used to achieve viral suppression in this patient population is essential
This retrospective study will be performed across a not-for-profit multi-clinic infectious disease organization in the Southeast United States comprising 12 clinics This multi-clinic infectious disease organization provided care to over 6000 PWH over the last 5 years 25 of those PWH identified as cisgender females 60 of the total PWH were ages 50 years and older Over 50 of PWH identified their race as a racial andor ethnic minority
10 out of 12 clinics are located in 5 of Floridas 6 top counties for prevalence of persons with HIV Miami-Dade Broward Orange Palm Beach and Hillsborough Counties 6 out of 12 clinics provide care for persons with HIV with Ryan White persons with federal poverty level below 400 Clinics across the organization provide rapid entry to care for PWH to enter care for the first time treatment naïve andor re-enter care after being out of care andor off of ART The rapid entry to care model also provides the opportunity to review clinical outcomes of PWH starting on either 2DR or 3DR who are re-entering care with an unknown history of resistance
A recent study demonstrated that PWH in the United States with 2 or more SDOH indicators were 20 less likely to report excellent adherence in the prior 30 days and 10 less likely to achieve sustained viral suppression in the prior year4 Furthermore as HIV disproportionately affects persons of lower socioeconomic status who are experiencing multiple SDOH indicators identifying ART that can be used to achieve viral suppression in this patient population is essential
This retrospective study will be performed across a not-for-profit multi-clinic infectious disease organization in the Southeast United States comprising 12 clinics This multi-clinic infectious disease organization provided care to over 6000 PWH over the last 5 years 25 of those PWH identified as cisgender females 60 of the total PWH were ages 50 years and older Over 50 of PWH identified their race as a racial andor ethnic minority
10 out of 12 clinics are located in 5 of Floridas 6 top counties for prevalence of persons with HIV Miami-Dade Broward Orange Palm Beach and Hillsborough Counties 6 out of 12 clinics provide care for persons with HIV with Ryan White persons with federal poverty level below 400 Clinics across the organization provide rapid entry to care for PWH to enter care for the first time treatment naïve andor re-enter care after being out of care andor off of ART The rapid entry to care model also provides the opportunity to review clinical outcomes of PWH starting on either 2DR or 3DR who are re-entering care with an unknown history of resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None