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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127290
• Other study ID #: CARE4ART
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: Euresist Network GEIE
• Contact: FRANCESCA INCARDONA
• Phone: +393356112830
• Email: francesca.incardona[@]euresist.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne
Italy	University Hospital of Siena	Siena
Poland	Pomeranian Medical University Szczecin	Szczecin
Sweden	Karolinska Institutet	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Euresist Network GEIE	Karolinska Institutet, Pomeranian Medical University Szczecin, University Hospital of Cologne, University of Siena

Countries where clinical trial is conducted

Germany,  Italy,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Load at 1 year	Viral Load after one year from the therapy start or at virological failure	1 year
Secondary	number and types of DRM at baseline	drug resistance mutations at baseline	1 week
Secondary	number and types of DRM1 after 1 year	drug resistance mutations after 1 year or at virological failure	1 year