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

Recruiting

• Conditions: HIV-1-infection

• Registration Number: NCT06127290
• Lead Sponsor: Euresist Network GEIE

Brief 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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-03-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• naïve patients starting 2nd generation INSTI treatment
• first line patients under 2nd generation INSTI treatment with either viral RNA sequence before therapy start, or PBMC available with PBMC sample date not more than 3 years from therapy start date (with reasonably sure history of no failure in the interval from therapy start date to PBMC sample date]).

Exclusion Criteria

• patients not having a signed informed consent for the EIDB data repository, if required by local/national legislation in order to have data in the common data repository.
• patients not having Signed Informed consent for the present study, if required by local authorities iii) Persons aged < 18 at baseline

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral Load at 1 year	1 year	Viral Load after one year from the therapy start or at virological failure

Secondary Outcome Measures

Name	Time	Method
number and types of DRM at baseline	1 week	drug resistance mutations at baseline
number and types of DRM1 after 1 year	1 year	drug resistance mutations after 1 year or at virological failure

Trial Locations

Locations (4)

University Hospital of Cologne; 🇩🇪 Cologne, Germany

University Hospital of Siena; 🇮🇹 Siena, Italy

Pomeranian Medical University Szczecin; 🇵🇱 Szczecin, Poland

Karolinska Institutet; 🇸🇪 Stockholm, Sweden