Skip to main content
OpenTrials
Completed

NCT Number: NCT04568239

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ARVD

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. probability of virological failure

    Time frame: 12 months

    probability of virological failure that is defined as HIV-RNA >50 copies/mL in 2 consecutive determinations or ≥200 copies/mL in a single determination. This outcome will be evaluated overall and between the M184V- and M184V+ patients' groups.

Sponsors and collaborators

Lead sponsor

Association de Recherche en Virologie et Dermatologie

Other

Registry information

Official study title

Impact of M184V on the Virological Efficacy to Lamivudine/Dolutegravir

Acronym: LAMRES

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2020
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.