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临床试验/NCT06127290
NCT06127290招募中不适用

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

Euresist Network GEIE4 个研究点 分布在 4 个国家目标入组 200 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
4
主要终点
Viral Load at 1 year

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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]).

排除标准

  • 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

结局指标

主要结局

Viral Load at 1 year

时间窗: 1 year

Viral Load after one year from the therapy start or at virological failure

次要结局

  • number and types of DRM at baseline(1 week)
  • number and types of DRM1 after 1 year(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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