HIV-1-infectionNCT06127290
HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia
An observational study of HIV-1-infection, run by Euresist Network GEIE at 4 sites in 4 countries.
Trial summary
Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- How many people
- 200 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Dec 2021to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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]).
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne
ROLF KAISER, PROF, rolf.kaiser@uk-koeln.de
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Siena
Siena
Maurizio Zazzi, Prof, maurizio.zazzi@gmail.com
Poland1 site, 1 recruiting
- Recruiting
Pomeranian Medical University Szczecin
Szczecin
Miłosz Parczewski, Prof, milosz.parczewski@pum.edu.pl
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm
ANDERS SONNERBORG, PROF, anders.sonnerborg@ki.se
About this study
Cohort based prospective monitoring of the spread of HIV drug resistance during a phase when new anti-HIV drugs are introduced.
Read the 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.
- Conditions
- HIV-1-infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 patients naive to therapies | HIV-1 patients naive to therapies with sub subtype A6 treated in first line with INSTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load at 1 year
Viral Load after one year from the therapy start or at virological failure
Measured: 1 year
Secondary outcomes (2)
number and types of DRM at baseline
drug resistance mutations at baseline
Measured: 1 week
number and types of DRM1 after 1 year
drug resistance mutations after 1 year or at virological failure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Dec 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Euresist Network GEIE
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, University of Siena, University Hospital of Cologne, Pomeranian Medical University Szczecin
- Responsible party
- Sponsor
- Investigators
- FRANCESCA INCARDONA, Study chair, Euresist Network GEIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127290
- Sponsor's protocol ID
- CARE4ART
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Resistance, Molecular Epidemiology and New Treatment Strategies in the Eastern European Region and in Russia
- ClinicalTrials.gov ID
- NCT06127290
- Acronym / sponsor ID
- CARE4ART
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Euresist Network GEIEUniversity, hospital or other
- Collaborators
- Karolinska Institutet, University of Siena, University Hospital of Cologne, Pomeranian Medical University Szczecin
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 patients naive to therapies | – | –HIV-1 patients naive to therapies with sub subtype A6 treated in first line with INSTI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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]).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viral Load at 1 year
Time frame: 1 year
Viral Load after one year from the therapy start or at virological failure
2 secondary outcomes
number and types of DRM at baseline
Time frame: 1 week
number and types of DRM1 after 1 year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FRANCESCA INCARDONA study chair
Euresist Network GEIE
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by Euresist Network GEIE at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy, Poland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FRANCESCA INCARDONA (+393356112830, francesca.incardona@euresist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Load at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.