2024-513941-35-00尚未招募1/2 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
Centre de Recherches et d’Etudes sur les Pathologies Infectieuses, Tropicales et le VIH/Sida6 个研究点 分布在 3 个国家目标入组 118 人开始时间: 2024年12月13日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- The proportion of patients with virological failure before or at week 48. Protocol virological failure is defined as two pVL>50 copies/mL two weeks apart.
研究概览
简要总结
To evaluate the virological efficacy at week 48 of once daily doravirine plus raltegravir dual therapy in HIV-1 infected patients suppressed on ART.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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 18 months prior to/or including screening visit (W-6/W-4), documented by at least 2 time-points with authorization of an isolated HIV-RNA plasma VL between 50 to 400 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).
排除标准
- •Absence of RT and INI HIV sequence available (past genotypes or failure of amplification of DNA at screening) in case of previous virological failure.
- •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 women with a desire to become pregnant or breastfeeding
- •HBV co-infection
- •Hemoglobin <9 g/dL* (*Being a hemophiliac is not an exclusionary criterion)
- •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
结局指标
主要结局
The proportion of patients with virological failure before or at week 48. Protocol virological failure is defined as two pVL>50 copies/mL two weeks apart.
The proportion of patients with virological failure before or at week 48. Protocol virological failure is defined as two pVL>50 copies/mL two weeks apart.
次要结局
- Proportion of patients maintaining viral suppression (pVL <50 copies/mL, Snapshot approach
- Evolution of CD4 and CD8 T-cells, and CD4/CD8 ratio
- Proportion of patients with virological blips (HIV-RNA pVL>50 copies/mL followed by a second measurement <50 copies/mL)
- Resistance profile in case of protocol defined virological failure (PDVF)
- Proportion of patients with acquired resistance mutation among those with PDVF
- Frequency of grade 3 and 4 events
- Quality of life assessed by self-questionnaire at screening, D0, W24, W48, W72, W96
- Observance assessed by self-questionnaire at D0, W24, W48, W96
- To assess HIV-RNA viral load and Cmin (Minimal Drug Concentration) of doravirine/raltegravir D0, W24 and W48 visits for patients in “Immediate switch” arm and D0, W72 and W96 visits for patients in “delayed switch” arm in human male genital compartment (30 patients included in the french centers)
- Evaluate the maintenance of HIV viral suppression as well as changes in neuronal injury and inflammatory markers in cerebrospinal fluid (CSF) at D0 and W48 (CSF sub-study, 15 patients included in the Spanish centers)
研究者
Dr Romain PALICH
Scientific
Centre de Recherches et d’Etudes sur les Pathologies Infectieuses, Tropicales et le VIH/Sida
研究点 (6)
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