HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HIV-1-infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Italy, Poland, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced.
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.
Primary outcome measures
- Viral Load at 1 year [Time frame: 1 year]
Secondary outcome measures (2)
- number and types of DRM at baseline [Time frame: 1 week]
- number and types of DRM1 after 1 year [Time frame: 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital of Cologne — Cologne
Italy · 1 center
- University Hospital of Siena — Siena
Poland · 1 center
- Pomeranian Medical University Szczecin — Szczecin
Sweden · 1 center
- Karolinska Institutet — Stockholm
Identifiers
NCT: NCT06127290 · CARE4ART