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

NCT06127290 | Recruiting

• 1 other identifier: CARE4ART
• Study Type: observational
• Target: 200
• Locations: 4 countries
• Sites: 4

Brief Summary

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

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Viral Load at 1 year

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

  1 year

Secondary Outcomes (2)

• number and types of DRM at baseline

  1 week

• number and types of DRM1 after 1 year

  1 year

Study Arms (1)

HIV-1 patients naive to therapies

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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\]).

You may not qualify if:

• 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

Sponsors & Collaborators

• Euresist Network GEIE: lead
• Karolinska Institutet: collaborator
• University of Siena: collaborator
• University Hospital of Cologne: collaborator
• Pomeranian Medical University Szczecin: collaborator

Study Sites (4)

University Hospital of Cologne

Cologne, Germany

RECRUITING

University Hospital of Siena

Siena, Italy

RECRUITING

Pomeranian Medical University Szczecin

Szczecin, Poland

RECRUITING

Karolinska Institutet

Stockholm, Sweden

RECRUITING

Study Officials

• FRANCESCA INCARDONA

  Euresist Network GEIE

  STUDY CHAIR

Central Study Contacts

FRANCESCA INCARDONA

CONTACT

+393356112830; francesca.incardona@euresist.org

dario corsini

CONTACT

+39 3483381097; dario.corsini@euresist.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2021
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

IT (1); DE (1); PL (1); SE (1)