NCT03858478Unknown4 期
Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba17 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年11月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 17
- 主要终点
- To achieve virological suppression (plasma HIV-RNA < 50 copies/ml) at Month 6 (M6)on study treatment with a first-line treatment with TAF / FTC/ BIC initiated at the first clinical contact (Snapshot method)
研究概览
简要总结
Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France
详细描述
- Patient treated at the first clinical contact
- 18 sites (hospitals) in France
- Treatment during 48 weeks with principal objective at W24 (plasma HIV-RNA < 50 copies/ml)
- Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir in hair sample
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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)
研究组 & 干预措施
Biktarvy arm
Experimental
one tablet of BIKTARVY including [TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg) ] one tablet once a day for 48 weeks
干预措施: Biktarvy arm (Drug)
结局指标
主要结局
To achieve virological suppression (plasma HIV-RNA < 50 copies/ml) at Month 6 (M6)on study treatment with a first-line treatment with TAF / FTC/ BIC initiated at the first clinical contact (Snapshot method)
时间窗: virological suppression at Month 6 (M6)
次要结局
- proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)(DAY 0 (D0))
- proportion of participants with plasma HIV-RNA < 50 copies/ml(Month 1 (M1), Month 3 (M3), Month 6 (M6), Month 9 (M9), Month 12 (M12))
- change in CD4 T cell count(between DAY 0 (D0) and Month 3 (M3), Month 6 (M6) and Month 12 (M12))
- change in CD4/CD8 ratio(between DAY 0 (D0) and Month 6 (M6) and Month 12 (M12))
- proportion of participants requiring discontinuation/modification of TAF/FTC/Bictegravir due to (i) Baseline resistance to one of the study drugs, (ii) adverse events leading to study treatment discontinuation/Modification(Between DAY 0 (D0) and Month 12 (M12))
- proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment)(Between DAY 0 (D0) and Month 12 (M12))
- proportion of participants with protocol defined virological failure (plasma HIV-RNA > 400 copies/ml at Week 12 confirmed on a second sample drawn 15-21 days later, or two consecutive plasma HIV-RNA > 50 copies/ml within 15-21 days as of Week 24)(Between Month 6 (M6) and Month 12 (M12))
- proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure(Between Month 6 (M6) and Month 12 (M12))
- number of comedications used during the 12-months study period(Between DAY 0 (D0) and Month 12 (M12))
- adherence to study treatment evaluated by drug concentrations measurement in hair(Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12))
- proportion of participants lost to follow-up throughout the 12-months study period (LFU = having missed more than two consecutive visits except for W24 and W48 visit)(Between DAY 0 (D0) and Month 12 (M12))
- participants' acceptability of immediate antiretroviral initiation treatment (self-assessed auto-questionnaires(At Day 0 (D0), Month 3 (M3), Month 6 (M6) and Month 12 (M12))
- adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall),(Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12))
- adherence to study treatment evaluated by drug concentrations measurement in plasma(Month 1 (M1), Month 3 (M3), Month 6 (M6) and Month 12 (M12))
- type of comedications used during the 12-months study period(Between DAY 0 (D0) and Month 12 (M12))
研究者
研究点 (17)
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