EUCTR2019-004195-19-FR进行中（未招募）1 期
A randomized comparative phase II trial evaluating the capacity of the dual combination doravirine/raltegravir to maintain virological success in HIV-1 infected patients with an HIV-RNA plasma viremia below 50 copies/mL under a current antiretroviral regimen - DORA
Centre de Recherche et d’Etudes sur la Pathologie Tropicale et le Sida (CREPATS)0 个研究点目标入组 150 人开始时间: 2020年3月11日最近更新:
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
- 150
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
- •Age = 18 years
- •Patients with HIV-1 documented infection
- •CD4 = 200/mm3
- •On stable combined ART regimen with at least 2 drugs for at least 6 months
- •HIV-RNA plasma VL = 50 copies/mL during the last 12 months prior to screening visit (W-6/W-4), documented by at least 2 time-points with no more than one blip (defined as one HIV-RNA plasma VL between 51 and 200 copies/mL followed by one HIV-RNA plasma VL = 50 copies/mL)
- •Naive to doravirine
- •Absence of resistance to doravirine* and/or raltegravir**(see list mutations below)
- •-on all HIV-genotypes with available RT and integrase gene sequences allowing resistance interpretation in case of previous virological failure
- •-or on DNA genotype performed at screening if HIV genotype is not available in case of prior virological failure.
- •Signed informed consent form.
- •Patient affiliated to a social insurance regimen. For French patients only: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme).
- •*Mutations associated to doravirine resistance are: V106A/M, Y188L, G190E/S, M230L, F227C, at least 2 among: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y
- •**Mutations associated to raltegravir resistance are: T66A/K, E92Q, G118R, F121Y, G140A/S Y143A/C/G/H/R/S, Q148E/G/H/K/R, V151L, N155H/S/T, E157Q, S230R, R263K, L74 F/I + V75I.
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Absence of RT and INI HIV sequence available (past genotypes or failure of amplification of DNA at screening)
- •HBV co-infection
- •Hemoglobin <9 g/dL
- •Platelets <80,000/mm3
- •Creatinine clearance <60 mL/min (MDRD)
- •AST or ALT =5N
- •Concomitant DAA for anti-HCV therapy
- •Any severe concomitant illness
- •Any drug with potential drug-drug interaction with doravirine
- •Concomitant treatment using interferon, interleukins or any other immune-therapy or chemotherapy
- •Concomitant prophylactic or curative treatment for an opportunistic infection
- •All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
- •Subjects under sauvegarde de justice (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
- •Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase
- •Pregnant women or breastfeeding women
研究者
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