Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)

NCT ID: NCT04568239

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 712 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-08-01

Brief Summary

In view of the prolongation of patients living with HIV's 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 3TC/DTG. There are few data on a direct comparison of 3TC/DTG efficacy in patients harboring or not harboring the M184V. So, there is a need to assess the efficacy of 3TC/DTG 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 copies/mL who were switched to 3TC/DTG in order to compare the virological efficacy of 3TC/DTG in patients with and without a history of M184V detection in a previous resistance genotype. This study aimed to analyze 800 patients switched to DTG/3TC in clinical real setting in large European (France, Italy, Spain) database.

Conditions

HIV-1-infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

M184V + group and M184 - group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• HIV-1 infected
• Age ≥ 18 years
• Switched to 3TC/DTG while having HIV-RNA ≤50 copies/mL on any ART regimen
• Followed for at least 1 year after 3TC/DTG switch
• With at least 1 previous genotype
• With at least 1 virological follow-up after switching to 3TC/DTG

Exclusion Criteria

• No genotypic resistance test available before switching to DTG/3TC

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association de Recherche en Virologie et Dermatologie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Genevieve Marcelin, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sorbonne University; APHP

Locations

ARVD

Paris, , France

Countries

France

Other Identifiers

ARVD-LAMRES

Identifier Type: -

Identifier Source: org_study_id