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RecruitingNCT06127290Updated Feb 27, 2025

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

An observational study in HIV-1-infection, sponsored by Euresist Network GEIE. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by Euresist Network GEIE · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Dec 2021; still recruiting 4 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • HIV-1-infection
03

In context

Lead sponsor

Euresist Network GEIE is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

prospectively enrolled treatment naïve patients who are put on antiretroviral therapy including 2nd generation INSTI. Random selection from the local HIV database will be made among persons who fulfil the inclusion criteria. Consecutive persons from the list attending outpatient clinic will be enrolled by the treating physician/study nurse.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • HIV-1 patients naive to therapies

    HIV-1 patients naive to therapies with sub subtype A6 treated in first line with INSTI

06

What researchers measure

Primary outcomes

  1. Viral Load at 1 year

    Viral Load after one year from the therapy start or at virological failure

    Time frame: 1 year

Secondary outcomes

  1. number and types of DRM at baseline

    drug resistance mutations at baseline

    Time frame: 1 week

  2. number and types of DRM1 after 1 year

    drug resistance mutations after 1 year or at virological failure

    Time frame: 1 year

07

Study locations

4 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06127290
Lead sponsor
Euresist Network GEIE
Collaborators
Karolinska Institutet, University of Siena, University Hospital of Cologne, Pomeranian Medical University Szczecin
Responsible party
Sponsor
First posted
Nov 13, 2023
Start date
Dec 1, 2021
Primary completion
Mar 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Feb 27, 2025

Study contacts

FRANCESCA INCARDONA
Contact
francesca.incardona@euresist.org
+393356112830
dario corsini
Contact
dario.corsini@euresist.org
+39 3483381097
FRANCESCA INCARDONA
study chair · Euresist Network GEIE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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