NCT06127290

HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Euresist Network GEIE · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced.

Detailed description

The patient cohort that has been set up includes both viral sequences and clinical/epidemiological data from diverse geographical regions in Russia and Ukraine, where continued prospective follow-up - both short-term and long-term - is warranted to monitor and investigate drug resistance and its impact on INSTI roll-out. Likewise, continued collection of samples and data is fundamental to study the impact of DRM (Drug Resistance Mutations) in Russia and the Eastern European Region for upcoming new drugs, in order to expand the knowledge and to get a representative pattern. In particular the promoter aims in the timeframe of 1 year at: * Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced. It requires a long-time follow up to identify any changing PDR (Pre-treatment Drug Resistance) patterns. * Cohort based prospective exploration of the temporal kinetics of subtypes and sub-subtypes in Russia in order to define the coming molecular epidemiology of HIV-1. * Expand the description of DRM (natural polymorphisms, pre-existing, acquired and off-target mutations) in a larger number of patients mainly from Russia. The samples and the collected data will be used to study the impact of DRM on the phenotypic sensitivity for INSTI and other already diffused drugs (NRTI/NNRTI). * Support the implementation and evaluation of the PDR surveillance plan which has been defined in accordance with WHO (World Health Organisation) directives.

Conditions

• HIV-1-infection

Timeline

• Start date: 2021-12-01
• Primary completion: 2025-03-31
• Completion: 2025-05-31
• First posted: 2023-11-13
• Last updated: 2025-02-27

Locations

4 sites across 4 countries: Germany, Italy, Poland, Sweden