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
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