Open Label, Randomized (1:1) Clinical Trial to Evaluate Switching From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE Study).
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Residual Viremia
研究概览
简要总结
Research hypothesis:
Switching from dual regimens based on dolutegravir plus a RTI to a single tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), lowers the exposure to Residual Viremia (and hence the risk of viral rebound), without increasing treatment toxicity.
详细描述
Study design Randomized, single-center, open-label, 96-week superiority study. Patients with HIV-RNA <50 copies/mL while receiving DTG plus one RTI will be randomized 1:1 to continue the ongoing treatment or to switch to E/C/F/TAF.
Randomization list will be a computer-generated list (with equal block sizes) and will be incorporated within an electronic clinical report form (eCRF).
Patients will be evaluated at screening, baseline, week 4, 8, 16, 24, 32, 40, 48, 60, 72, 84, 96 or premature discontinuation.
At each visit the following evaluations will be performed:
- clinical assessment.
- routine laboratory tests (hematological tests and clinical chemistry). Additional blood samples will be collected at specified visits for storage and further determinations (e.g. RV by a single-copy assay).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Willing and able to provide informed consent
- •On a stable (at least 3 months) antiretroviral therapy with DTG 50 mg QD plus one RTI
- •HIV-RNA <50 copies/mL since at least 6 months
排除标准
- •Active AIDS-defining condition (except Kaposi's sarcoma non requiring systemic chemotherapy)
- •Serious illness requiring systemic treatment and/or hospitalization
- •Current use of immunomodulant or immunosuppressive drugs
- •Need (or will likely need) of treatment with antacids
- •Use of drugs contraindicated with study drugs, according to technical sheets
- •Previous suboptimal therapies with NRTIs or presence of TAMs (type 1 or 2) in previous resistance tests (patients with the 184I/V mutation alone are allowed to enter the study)
- •Resistance or previous virological failure to InSTIs
- •Detectable HCV-RNA
- •Documented allergy to COBI or EVG or FTC or tenofovir.
- •Absolute neutrophil count (ANC) <500/µL
- •Haemoglobin <8.0 g/dL
- •Platelet count <50,000/µL
- •eGFR <30 mL/min/1.73m2 by CKD-EPI equation
- •Alanine aminotransferase (ALT) more than 5 times the upper limit of normal (ULN)
- •Presence of Child Pugh Class B or C liver cirrhosis.
- •Pregnancy or breastfeeding
- •Woman of childbearing potential who does not agree to adopt highly effective contraception.
研究组 & 干预措施
Genvoya 150Mg-150Mg-200Mg-10Mg Table
switch to the treatment Genvoya 150Mg-150Mg-200Mg-10Mg Table (1 pill every 24 hour)
干预措施: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet (Drug)
Dolutegravir 50 mg plus one RTI (at label dose)
Continuing Dolutegravir 50 mg (1 pill every 24 hours) plus one RTI (at label dose)
干预措施: Dolutegravir 50 mg plus one RTI (Drug)
结局指标
主要结局
Residual Viremia
时间窗: 48 weeks
To investigate RV through 48 weeks in virologically suppressed patients randomized to continue treatment with DTG plus a single RTI or to switch to E/C/F/TAF.
次要结局
- virological rebound(48 weeks)
- viral reservoir(96 weeks)
- QOL(96 weeks)
- Adherence(48 weeks)
- Virological failure(96 weeks)
- Adherence.(96 weeks)
研究者
Castagna Antonella
Professor
IRCCS San Raffaele