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.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Concerning the main analysis, the proportion of patients with an undetectable viral load at 24 weeks will be carried out per-protocol, that is to say that subjects who interrupt the experimental treatment without having reached a classifying event for the main criterion judgment or lost to follow-up will not be considered failures. A sensitivity analysis will be conducted, according to the FDA snapshot algorithm, on an intention-to-treat-exposed (ITT-e) basis.
研究概览
简要总结
Efficacy of the Doravirine / TDF / Lamivudine combination for 24 weeks on virological efficacy in the event of a history of M184V/I mutation not present on the current proviral DNA.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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
- •At inclusion, the patient must present complete sensitivity to doravirine and tenofovir according to the genotype of the proviral DNA centralized in Saint-Louis
排除标准
- •M184V/I mutation present at inclusion on the standard proviral DNA genotype (Sanger technique)
- •Resistance to TDF on a previous genotype carried out on plasma HIV-RNA OR on standard proviral DNA
- •Patient who has received injectable antiretroviral treatment for less than 12 months
- •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
- •Patient already under DOR
- •Patients under guardianship or curatorship
- •Resistance to DOR on a previous genotype carried out on plasma HIV-RNA OR on standard proviral DNA
结局指标
主要结局
Concerning the main analysis, the proportion of patients with an undetectable viral load at 24 weeks will be carried out per-protocol, that is to say that subjects who interrupt the experimental treatment without having reached a classifying event for the main criterion judgment or lost to follow-up will not be considered failures. A sensitivity analysis will be conducted, according to the FDA snapshot algorithm, on an intention-to-treat-exposed (ITT-e) basis.
Concerning the main analysis, the proportion of patients with an undetectable viral load at 24 weeks will be carried out per-protocol, that is to say that subjects who interrupt the experimental treatment without having reached a classifying event for the main criterion judgment or lost to follow-up will not be considered failures. A sensitivity analysis will be conducted, according to the FDA snapshot algorithm, on an intention-to-treat-exposed (ITT-e) basis.
次要结局
- Proportion of patients with an undetectable viral load (<50 copies/ml) at 48 weeks, according to the FDA's intention-to-treat-exposed (ITT-e) snapshot algorithm. The intention-to-treat exposed population includes all patients who received at least one dose of DOR/3TC/TDF.
- volution of the NGS genotype on proviral DNA between baseline, S24 and S48
- Delta CD4 between BL, S24 and S48
- Delta weight between BL, S24 and S48
- Delta LDL, HDL, Triglycerides and total cholesterol between BL, W24 and W48
- Delta QoL SF36 between BL, S24 and S48
研究者
Investigateur Coordinateur
Scientific
Centre Hospitalier Universitaire De Caen Normandie