CTIS2023-505845-17-00进行中（未招募）1 期
Efficacy of the Doravirine/Tenofovir Disoproxil Fumarate/Lamivudine combination in people living with HIV with a history of M184V/I mutation and virologically controlled: a phase II, open-label, non-comparative pilot study. - Drive Off Road
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Adult patient living with HIV-1, Receiving stable antiretroviral treatment for at least 3 months, HIV RNA VL<50cp/mL for at least 6 months, Presence of the M184V/I mutation in at least one previous genotype performed on plasma HIV-RNA (at least 6 months undetectable), but absent from the genotype on current standard proviral DNA (Sanger technique), Signed informed consent
排除标准
- •M184V/I mutation present at inclusion on the standard proviral DNA genotype (Sanger technique), Renal failure with CrCl < 50ml/min, History of genotypic mutation associated with resistance to DOR or TDF, Contraindication to the use of DOR/TDF/3TC, Hypersensitivity to doravirine, tenofovir, lamivudine or one of the excipients (notably lactose), Current or recent treatments with a strong CYP3A4 inducer, Feeding with milk, Pregnancy, Patient already under DOR, Patients under guardianship or curatorship
研究者
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