Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04568239
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2020-09-24
Brief Title:
Impact of M184V on the Virological Efficacy to 3TCDTG LAMRES
Sponsor:
Association de Recherche en Virologie et Dermatologie
Organization:
Association de Recherche en Virologie et Dermatologie
Study Overview
Official Title:
Impact of M184V on the Virological Efficacy to LamivudineDolutegravir
Status:
COMPLETED
Status Verified Date:
2023-02
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:
LAMRES
Brief Summary:
In view of the prolongation of patients living with HIVs life expectancy the question of optimization of ART which is still a life-long treatment becomes central While most patients achieve virological success their treatments often need to be optimized in order to limit adverse events drugs interactions and to improve adherence The switch to dual regimen strategies represent one of the approaches for treatment optimization Indeed dual therapy regimens have shown non-inferior efficacy vs triple therapy as simplification therapy and more recently also as first line therapy From the real-life data it emerges that today in simplification strategies the dual regimen therapies are prescribed even in patients with a history of virological failure Circulating HIV-1 resistant variants can be archived in viral reservoirs where they can persist for years and can reemerge in case of therapeutic selective pressure In particular previous selection of M184V may have an impact on virological response to 3TCDTG There are few data on a direct comparison of 3TCDTG efficacy in patients harboring or not harboring the M184V So there is a need to assess the efficacy of 3TCDTG in patients with past M184V mutation in a large set of patients followed in clinical setting
Thus the investigators propose a retrospective study of patients with HIV-RNA 50 copiesmL who were switched to 3TCDTG in order to compare the virological efficacy of 3TCDTG in patients with and without a history of M184V detection in a previous resistance genotype This study aimed to analyze 800 patients switched to DTG3TC in clinical real setting in large European France Italy Spain database
Thus the investigators propose a retrospective study of patients with HIV-RNA 50 copiesmL who were switched to 3TCDTG in order to compare the virological efficacy of 3TCDTG in patients with and without a history of M184V detection in a previous resistance genotype This study aimed to analyze 800 patients switched to DTG3TC in clinical real setting in large European France Italy Spain database
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None