Monitoring HIV drug resistance and treatment strategies in Eastern Europe and Russia
HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia
This study is trying to see how new HIV drugs work in people in Eastern Europe and Russia by looking at how drug resistance changes over time and how it affects treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Euresist Network GEIE Academic / other |
| Locations | 4 sites (Cologne and 3 other locations) |
| Trial ID | NCT06127290 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates include naïve patients starting 2nd generation INSTI treatment or first-line patients under 2nd generation INSTI treatment with relevant viral RNA sequences.
Not a fit: Patients under 18 years old or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of HIV drug resistance and improve treatment strategies for patients in Eastern Europe and Russia.
How similar studies have performed: Other studies have shown success in monitoring HIV drug resistance, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cologne and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.