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

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

Study Overview

• Status: Recruiting
• Conditions: HIV-1-infection

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: FRANCESCA INCARDONA; Phone Number: +393356112830; Email: francesca.incardona@euresist.org
• Study Contact Backup: Name: dario corsini; Phone Number: +39 3483381097; Email: dario.corsini@euresist.org

Study Locations

• Germany
  • Cologne, Germany
    • Recruiting
    • University Hospital of Cologne
    • Contact: ROLF KAISER, PROF; Email: rolf.kaiser@uk-koeln.de
• Italy
  • Siena, Italy
    • Recruiting
    • University Hospital of Siena
    • Contact: Maurizio Zazzi, Prof; Email: maurizio.zazzi@gmail.com
• Poland
  • Szczecin, Poland
    • Recruiting
    • Pomeranian Medical University Szczecin
    • Contact: Miłosz Parczewski, Prof; Email: milosz.parczewski@pum.edu.pl
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Institutet
    • Contact: ANDERS SONNERBORG, PROF; Email: anders.sonnerborg@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral Load at 1 year	Viral Load after one year from the therapy start or at virological failure	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number and types of DRM at baseline	drug resistance mutations at baseline	1 week
number and types of DRM1 after 1 year	drug resistance mutations after 1 year or at virological failure	1 year

Collaborators and Investigators

• Sponsor: Euresist Network GEIE
• Collaborators: Karolinska Institutet; Pomeranian Medical University Szczecin; University Hospital of Cologne; University of Siena
• Investigators: Study Chair: FRANCESCA INCARDONA, Euresist Network GEIE

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CARE4ART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No