Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-01-01
2023-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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HIV POLISH (PL)
HIV infected people with polish nationality, who most probably acquired infection in Poland
HIV drug resistance testing
HIV drug resistance testing in people newly diagnosed in HIV in Poland
HIV MIGRANTS (M)
HIV infected people, originating from outside of Poland, where they were diagnosed with HIV infection
HIV drug resistance testing
HIV drug resistance testing in people newly diagnosed in HIV in Poland
Interventions
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HIV drug resistance testing
HIV drug resistance testing in people newly diagnosed in HIV in Poland
Eligibility Criteria
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Inclusion Criteria
* no history of antiretrovirals intake (PrEP, PEP)
* age 18 years or olde
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Andrzej Załęski
Principal Investigator
Principal Investigators
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Alicja Wiercińska-Drapało, PhD
Role: STUDY_CHAIR
Department of Infectious Diseases,Tropical Diseases and Hepatology, Medical University of Warsaw
Locations
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Department of Infectious Diseases, Tropical Diseases and Hepatology, Medical University of Warsaw
Warsaw, Mazowia, Poland
Countries
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Central Contacts
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References
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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.
Shafer 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.
Zaleski 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.
Related Links
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Hiv surveillance report
Migration report in Poland
Migration report in Poland
Hiv resistance pattern
HIV/AIDS European guidelines on diagnostics and treatment
Other Identifiers
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HIVresistancePL
Identifier Type: -
Identifier Source: org_study_id