Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619288
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Good-first BFTAF As First-line ART
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Good-first a Multicohort Study of BFTAF As First-line ART in a Public Hospital in Eastern China
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a multicohort study conducted at Affiliated Hospital of Nantong University and Nantong Third Peoples Hospital Designated Hospital for HIVAIDS Treatment of Nantong City China The study would involve 630 patients initiating HIV treatment divided into six cohorts The enrollment period for the prospective cohort is from July 2024 to June 2025 while the enrollment period for the retrospective cohort is from January 2020 to June 2023
Detailed Description:
Bictegraviremtricitabinetenofovir alafenamide BFTAF is recommended for initiating antiretroviral therapy ART in newly diagnosed HIV patients including those with advanced disease However clinical data for this group is limited and the high cost of BFTAF may hinder its widespread use as a first-line treatment
This study aim to gather real-world evidence on the clinical practice of BFTAF as a first-line ART and address the knowledge gap regarding its cost-effectiveness A multicohort study at the Designated Hospital for HIVAIDS Treatment of Nantong City China involves 630 patients initiating HIV treatment divided into six cohorts There are 230 prospective patients on BFTAF 115 late presenters with CD4 350 cellsĪ¼L or an AIDS-defining event and 115 early presenters Additionally there are 400 retrospective patients on either tenofovirlamivudineefavirenz TDF3TCEFV 100 for each presentation group or dolutegravirlamivudine DTG3TC 100 for each presentation group The enrollment period for the prospective cohort is from July 2024 to June 2025 while the enrollment period for the retrospective cohort is from January 2020 to June 2023
Data will be collected at baseline and at specific intervals over 48 weeks using electronic health records and patient-reported outcomes Clinical data include time from diagnosis to ART initiation plasma viral load VL CD4 count adverse events treatment adherence and quality of life QoL QoL improvements will be assessed through questionnaires Cost data will be collected following healthcare reporting standards A microsimulation model will be adapted The cost-effectiveness of BFTAF compared to the other regimens will be evaluated using clinical cohort data and modeling techniques to project long-term economic outcomes
This study was approved by the ethics committee of Nantong Third Peoples Hospital Consent will also be obtained from the participants during the study process
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology STROBE reporting guideline for cohort studies
This study aim to gather real-world evidence on the clinical practice of BFTAF as a first-line ART and address the knowledge gap regarding its cost-effectiveness A multicohort study at the Designated Hospital for HIVAIDS Treatment of Nantong City China involves 630 patients initiating HIV treatment divided into six cohorts There are 230 prospective patients on BFTAF 115 late presenters with CD4 350 cellsĪ¼L or an AIDS-defining event and 115 early presenters Additionally there are 400 retrospective patients on either tenofovirlamivudineefavirenz TDF3TCEFV 100 for each presentation group or dolutegravirlamivudine DTG3TC 100 for each presentation group The enrollment period for the prospective cohort is from July 2024 to June 2025 while the enrollment period for the retrospective cohort is from January 2020 to June 2023
Data will be collected at baseline and at specific intervals over 48 weeks using electronic health records and patient-reported outcomes Clinical data include time from diagnosis to ART initiation plasma viral load VL CD4 count adverse events treatment adherence and quality of life QoL QoL improvements will be assessed through questionnaires Cost data will be collected following healthcare reporting standards A microsimulation model will be adapted The cost-effectiveness of BFTAF compared to the other regimens will be evaluated using clinical cohort data and modeling techniques to project long-term economic outcomes
This study was approved by the ethics committee of Nantong Third Peoples Hospital Consent will also be obtained from the participants during the study process
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology STROBE reporting guideline for cohort studies
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