HIV InfectionsNCT04636736
HIV Drug Resistance Pattern Due to Migration in Poland
An observational study of HIV Infections and HIV-1-infection, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
According to the Polish governmental statistics migration of people from Ukraine to Poland is growing and only in year 2020 have come to Poland about a quarter of a million of Ukrainian migrants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HIV-1-infection, Resistant Infection
- What is being tested?
- HIV drug resistance testing
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: People diagnosed with HIV infection in Poland, originating from Poland and other countries
Who may be able to join
- recent diagnosis with HIV infection (<6 months)
- no history of antiretrovirals intake (PrEP, PEP)
- age 18 years or olde
Who cannot join
- failure to meet any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Infectious Diseases, Tropical Diseases and Hepatology, Medical University of Warsaw
Warsaw, Mazowia, 01-201
About this study
Official title: Possible Changes in HIV Drug Resistance Pattern Due to Migration of People From the Eastern Europe to Poland
According to the Polish governmental statistics migration of people from Ukraine to Poland is growing and only in year 2020 have come to Poland about a quarter of a million of Ukrainian migrants. As well, more than 40% of those diagnosed with HIV infection in the European Union (EU)/European Economic Area (EEA) in 2018 were also migrants, originating from countries with generalized HIV epidemics, such as Ukraine. Antiretroviral treatment should be started, based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.
Read the detailed description
BACKGROUND:
According to the Polish governmental statistics during the year 2020 have come to Poland about 240 thousand of ukarinian migrants, and it is estimated that nowadays in Poland live and work about 1.2 million of people from Ukraine. In recent years substantial increases in diagnosis of HIV infected people have been reported in some countries, including Poland. At the same time 42% of those diagnosed in the EU/EEA in 2018 were migrants, defined as originating from outside of the country in which they were diagnosed. More than one-third (40%) of newly diagnosed cases due to heterosexual transmission were among migrants originating from countries with generalized HIV epidemics, such as Ukraine. Overall in the EU/ EEA, and even in some settings with decrease in newly diagnosed HIV infections in men having sex with others men (MSM), new HIV diagnoses in migrant MSM have not declined at the same rate as those who are not foreign-born. Antiretroviral treatment should be started immediately in all HIV-positive patients, regardless of origin, race, gender or sexual preferences. The choose of first-line antiretroviral regimen is based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.
AIM OF THE STUDY:
Due to changes in epidemiological pattern in newly diagnosed patients with HIV infection in Poland and increase in number of HIV positive patients from Ukraine we aimed to asses whether the presence of drug resistance mutations in the population of Ukrainian patients differs from the pattern of resistance of not foreign born patients with newly diagnosed HIV infection in Poland. The potential differences may have further implications on antiretroviral regimens in drug naive HIV positive patients.
MATERIAL AND METHODS:
We have designed observational, prospective study which will be performed in several clinical centers in Poland. As a part of the study we will collect epidemiological (age, gender, origin, migration data, sexual preferences) and clinical data (HIV viral load, CD4+ cells count, presence of AIDS-defining diseases, proposed combined antiretrovirat therapy (cART) regimen and the response to the treatment, Hepatitis B (HBV) and C (HCV) co-infections).
In all patients, before starting antiretroviral treatment, presence of drug resistance mutations of HIV will be assessed. The molecular diagnostics will cover mutations to the nucleotide and non-nucleotide reverse transcriptase inhibitors (NRTI and NNRTI), protease inhibitors (PI) and as well integrase inhibitors (InSTI).
Statistical evaluation will be performed in subgroups of migrants and in patients born in Poland. The distribution of continuous variables will be analysed by the Shapiro-Wilk test. The data will be expressed as the median and interquartile range (IQR). Quantitative data will be analysed using the Mann-Whitney U test or Kruskal-Wallis ANOVA when appropriate. Qualitative data will be compared using the χ² test or the Fisher exact test. A P value of <0.05 will be considered statistically significant.
- Conditions
- HIV Infections, HIV-1-infection, Resistant Infection
- Being tested
- HIV drug resistance testing
- Keywords
- HIV-infection, AIDS, migration, cART, drug-resistance
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV drug resistance testingDiagnostic test
HIV drug resistance testing in people newly diagnosed in HIV in Poland
| Study group | Role | What they receive |
|---|---|---|
| HIV POLISH (PL) | HIV infected people with polish nationality, who most probably acquired infection in Poland Receives: Diagnostic Test: HIV drug resistance testing | |
| HIV MIGRANTS (M) | HIV infected people, originating from outside of Poland, where they were diagnosed with HIV infection Receives: Diagnostic Test: HIV drug resistance testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in HIV drug resistance pattern
Differences between people originating from Poland and from Eastern Europe
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrzej Załęski, Medical University of Warsaw
- Investigators
- Alicja Wiercińska-Drapało, PhD, Study chair, Department of Infectious Diseases,Tropical Diseases and Hepatology, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636736
- Sponsor's protocol ID
- HIVresistancePL
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to share the data
Publications
Wensing AM, Calvez V, Ceccherini-Silberstein F, Charpentier C, Gunthard HF, Paredes R, Shafer RW, Richman DD. 2019 update of the drug resistance mutations in HIV-1. Top Antivir Med. 2019 Sep;27(3):111-121.
PubMed 31634862Shafer RW, Rhee SY, Pillay D, Miller V, Sandstrom P, Schapiro JM, Kuritzkes DR, Bennett D. HIV-1 protease and reverse transcriptase mutations for drug resistance surveillance. AIDS. 2007 Jan 11;21(2):215-23. doi: 10.1097/QAD.0b013e328011e691.
PubMed 17197813Zaleski A, Lembas A, Dyda T, Siwak E, Osinska J, Suchacz M, Stempkowska-Rejek J, Strycharz M, Orzechowska J, Wiercinska-Drapalo A. Changes in Primary HIV-1 Drug Resistance Due to War Migration from Eastern Europe. J Immigr Minor Health. 2024 Feb;26(1):15-22. doi: 10.1007/s10903-023-01559-1. Epub 2023 Nov 16.
PubMed 37973713
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Changes in HIV Drug Resistance Pattern Due to Migration of People From the Eastern Europe to Poland
- ClinicalTrials.gov ID
- NCT04636736
- Acronym / sponsor ID
- HIVresistancePL
- Conditions
- HIV Infections, HIV-1-infection, Resistant Infection
- Keywords
- HIV-infection, AIDS, migration, cART, drug-resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 19 Nov 2020 (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.
According to the Polish governmental statistics migration of people from Ukraine to Poland is growing and only in year 2020 have come to Poland about a quarter of a million of Ukrainian migrants. As well, more than 40% of those diagnosed with HIV infection in the European Union (EU)/European Economic Area (EEA) in 2018 were also migrants, originating from countries with generalized HIV epidemics, such as Ukraine. Antiretroviral treatment should be started, based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.
Detailed description
BACKGROUND:
According to the Polish governmental statistics during the year 2020 have come to Poland about 240 thousand of ukarinian migrants, and it is estimated that nowadays in Poland live and work about 1.2 million of people from Ukraine. In recent years substantial increases in diagnosis of HIV infected people have been reported in some countries, including Poland. At the same time 42% of those diagnosed in the EU/EEA in 2018 were migrants, defined as originating from outside of the country in which they were diagnosed. More than one-third (40%) of newly diagnosed cases due to heterosexual transmission were among migrants originating from countries with generalized HIV epidemics, such as Ukraine. Overall in the EU/ EEA, and even in some settings with decrease in newly diagnosed HIV infections in men having sex with others men (MSM), new HIV diagnoses in migrant MSM have not declined at the same rate as those who are not foreign-born. Antiretroviral treatment should be started immediately in all HIV-positive patients, regardless of origin, race, gender or sexual preferences. The choose of first-line antiretroviral regimen is based, among others, on epidemiological data and evidence of presence of drug resistance mutations in a the population.
AIM OF THE STUDY:
Due to changes in epidemiological pattern in newly diagnosed patients with HIV infection in Poland and increase in number of HIV positive patients from Ukraine we aimed to asses whether the presence of drug resistance mutations in the population of Ukrainian patients differs from the pattern of resistance of not foreign born patients with newly diagnosed HIV infection in Poland. The potential differences may have further implications on antiretroviral regimens in drug naive HIV positive patients.
MATERIAL AND METHODS:
We have designed observational, prospective study which will be performed in several clinical centers in Poland. As a part of the study we will collect epidemiological (age, gender, origin, migration data, sexual preferences) and clinical data (HIV viral load, CD4+ cells count, presence of AIDS-defining diseases, proposed combined antiretrovirat therapy (cART) regimen and the response to the treatment, Hepatitis B (HBV) and C (HCV) co-infections).
In all patients, before starting antiretroviral treatment, presence of drug resistance mutations of HIV will be assessed. The molecular diagnostics will cover mutations to the nucleotide and non-nucleotide reverse transcriptase inhibitors (NRTI and NNRTI), protease inhibitors (PI) and as well integrase inhibitors (InSTI).
Statistical evaluation will be performed in subgroups of migrants and in patients born in Poland. The distribution of continuous variables will be analysed by the Shapiro-Wilk test. The data will be expressed as the median and interquartile range (IQR). Quantitative data will be analysed using the Mann-Whitney U test or Kruskal-Wallis ANOVA when appropriate. Qualitative data will be compared using the χ² test or the Fisher exact test. A P value of <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV POLISH (PL) | – | Diagnostic Test: HIV drug resistance testingHIV infected people with polish nationality, who most probably acquired infection in Poland |
| HIV MIGRANTS (M) | – | Diagnostic Test: HIV drug resistance testingHIV infected people, originating from outside of Poland, where they were diagnosed with HIV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People diagnosed with HIV infection in Poland, originating from Poland and other countries
Key inclusion criteria (3 listed)
- recent diagnosis with HIV infection (<6 months)
- no history of antiretrovirals intake (PrEP, PEP)
- age 18 years or olde
Key exclusion criteria (1 listed)
- failure to meet any of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV drug resistance testingHIV drug resistance testing in people newly diagnosed in HIV in Poland | Diagnostic test | HIV MIGRANTS (M), HIV POLISH (PL) |
Primary outcome
Difference in HIV drug resistance pattern
Time frame: 2 years
Differences between people originating from Poland and from Eastern Europe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Background: PubMed 31634862Wensing AM, Calvez V, Ceccherini-Silberstein F, Charpentier C, Gunthard HF, Paredes R, Shafer RW, Richman DD. 2019 update of the drug resistance mutations in HIV-1. Top Antivir Med. 2019 Sep;27(3):111-121.
- Background: PubMed 17197813Shafer RW, Rhee SY, Pillay D, Miller V, Sandstrom P, Schapiro JM, Kuritzkes DR, Bennett D. HIV-1 protease and reverse transcriptase mutations for drug resistance surveillance. AIDS. 2007 Jan 11;21(2):215-23. doi: 10.1097/QAD.0b013e328011e691.
- Derived from this study: PubMed 37973713Zaleski A, Lembas A, Dyda T, Siwak E, Osinska J, Suchacz M, Stempkowska-Rejek J, Strycharz M, Orzechowska J, Wiercinska-Drapalo A. Changes in Primary HIV-1 Drug Resistance Due to War Migration from Eastern Europe. J Immigr Minor Health. 2024 Feb;26(1):15-22. doi: 10.1007/s10903-023-01559-1. Epub 2023 Nov 16.
- Hiv surveillance reportLink provided by the sponsor.
- Migration report in PolandLink provided by the sponsor.
- Hiv resistance patternLink provided by the sponsor.
- HIV/AIDS European guidelines on diagnostics and treatmentLink provided by the sponsor.
- Individual participant dataSharing planned: No. there is no plan to share the data
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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. This study is not recruiting at the moment.
Alicja Wiercińska-Drapało, PhD study chair
Department of Infectious Diseases,Tropical Diseases and Hepatology, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV-1-infection, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Zaleski, PhD (048600982185, andrzejzaleski84@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in HIV drug resistance pattern (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636736, which also lists 3 linked publications.
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 23 Nov 2020.