Monitoring HIV drug resistance and treatment strategies in Eastern Europe and Russia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study involves a cohort-based prospective monitoring of HIV drug resistance as new anti-HIV drugs are introduced in Russia and Ukraine. It collects viral sequences and clinical data to investigate the spread of drug resistance mutations (DRM) and their impact on treatment efficacy. The study aims to explore the temporal dynamics of HIV-1 subtypes and to support the implementation of a pre-treatment drug resistance surveillance plan in accordance with WHO guidelines. Long-term follow-up will help identify changing patterns of pre-treatment drug resistance (PDR).

Why it matters

Who can join: the full rules

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

Where it's running

• 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 contacts

• Study coordinator: Francesca Incardona
• Email: francesca.incardona@euresist.org
• Phone: +393356112830

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.