Clinical trial NCT06127290: HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia
Official title: HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV-1-infection
Lead sponsor: Euresist Network GEIE
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: University of Siena
name: University Hospital of Cologne
name: Pomeranian Medical University Szczecin
First posted: 2023-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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

Primary outcomes:
measure: Viral Load at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: number and types of DRM at baseline
timeFrame: 1 week
measure: number and types of DRM1 after 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
city: Siena
country: Italy
facility: University Hospital of Siena
city: Szczecin
country: Poland
facility: Pomeranian Medical University Szczecin
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Euresist Network GEIE
name: FRANCESCA INCARDONA
role: STUDY_CHAIR
References: