EUCTR2019-002843-81-FR进行中（未招募）1 期
Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected patients over 65 years old at risk of polymedication - BILOLDER
IMEA0 个研究点目标入组 50 人开始时间: 2019年8月6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
- 50
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
- 性别
- All
入选标准
- •HIV-1-infected patient
- •Age > 65 years old
- •Plasma HIV RNA = 50 copies/mL for = 6 months: one blip between 50 et 200 cp/ml is allowed in the last 6 months before screening.
- •Currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat
- •No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. The reverse transcriptase resistant mutations M184V plus one TAM are allowed.
- •If no genotype is available, DNA genotype will be performed at screening visit: no resistance mutation to integrase inhibitors, the reverse transcriptase resistant mutations M184V plus one TAM are allowed.
- •Patient enrolled in or a beneficiary of a Social Security program (State Medical Aid or AME is not a Social Security program)
- •Informed consent form signed by patient and investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •HIV-2 infection
- •Currently receiving one of the following drugs : Hypericum perforatum,
- •rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate, cyclosporine, primidone, ténofovir et adéfovir.
- •Hemoglobin < 10g/dL
- •Platelets < 100 000/mm3
- •Hepatic transaminases AST and ALT > 3x upper limit of normal (ULN)
- •Severe hepatic insufficiency (Child Pugh Class C)
- •Creatininemia clairance < 30 mL/min (MDRD)
- •History or presence of allergy to the trial drugs or their components
- •Patients participating in another clinical trial including an exclusion period that is still in force during the screening phase
- •Patients under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.
研究者
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