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

HIV-1-infection Clinical Trial

— LAMRES  

Official title:

Impact of M184V on the Virological Efficacy to Lamivudine/Dolutegravir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568239
• Other study ID #: ARVD-LAMRES
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: February 2023
• Source: Association de Recherche en Virologie et Dermatologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Locations

Country	Name	City	State
France	ARVD	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association de Recherche en Virologie et Dermatologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probability of virological failure	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.	12 months