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临床试验/EUCTR2019-000812-27-FR
EUCTR2019-000812-27-FR进行中(未招募)1 期

Initiation of first-line antiretroviral treatment with TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the first clinical contact in France: Trial IMEA 055 – FAST - FAST

IMEA0 个研究点目标入组 110 人开始时间: 2019年2月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
110

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • -age > 18 years
  • -newly diagnosed HIV-infected individual evidenced by any of the following tests: (i) positive self-test, (ii) positive HIV Rapid antibody test, (iii) positive HIV immunoassay (ELISA 4th generation) test
  • -antiretroviral-treatment naive
  • -negative urine pregnancy test for women of childbearing potential and willing to use effective contraception (mechanical or medicamental)
  • -willing to sign an informed written consent–
  • -regular health insurance
  • -willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 110
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • -clinical symptoms suggestive of opportunistic infections
  • -participant not willing to provide two distinct contact information
  • -a woman who is pregnant or breast-feeding or planning to become pregnant during the expected study period.
  • -Co-medication with deleterious interaction with study treatment (eg enzyme inducer)

研究者

发起方
IMEA

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