Randomized, Open-label, Phase III Trial Comparing a Dual Nucleoside Analogues Strategy Preceded by a Triple Therapy Induction Period to an Immediate Strategy With Dolutegravir Plus Lamivudine in Antiretriviral naïve People Living With HIV With Viral Load < 50000 cp/mL and CD4 Cells >300/mm3
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- To demonstrate at W48 the non-inferiority
研究概览
简要总结
The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudine (3TC) preceded by a 16 week induction period with TDF or TAF plus FTC or 3TC plus an integrase inhibitor (INI) relative to an immediate 2-DR strategy with dolutegravir plus 3TC in HIV-infected antiretroviral therapy (ARV) naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA strictly lower than 50 000 cp/mL
详细描述
ANRS 173 ALTAR is a multicenter, comparative, international, open label, phase III randomized trial aiming at evaluating the non-inferiority of a TRI-BI (tritherapy-bitherapy) strategy (includes a 16 week - induction phase with 2 NRTI and a once daily integrase inhibitor followed by a bitherapy with TDF or TAF / XTC*) in its capacity to achieve viral suppression at week 48 versus immediate BI (bitherapy) strategy (DTG/3TC) in participants naïve to antiretroviral therapy with plasma HIV RNA strictly less than 50 000 copies/mL and CD4 cells count above 300/mm3.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV-1 infection (positive HIV-1 serology or plasma viral load)
- •Age ≥ 18 years
- •Therapeutic antiretroviral treatment-naive participant (history of prophylaxy is accepted)
- •CD4 cells count > 300 cells/mm3 at screening visit
- •HIV-1-RNA plasma viral load <50 000 copies/mL at screening visit
- •Full susceptibility to trial drugs (NRTI, INI) at screening visit
- •eGFR (epidermal growth factor receptor) > 60 mL /min (MDRD)
- •AST (aspartate aminotransferase), ALT(alanine transaminase) < 3x norm
- •Absence of any AIDS-defining event and/or opportunistic infection
- •Possible contact by phone and/or email in order to be informed in case of detectable HIV plasma viral load
- •Negative urinary pregnancy test at screening visit for women of childbearing age
- •Written and informed consent signed
- •For French participants only: subject enrolled in or a beneficiary of a Social Security programme (including State Medical Aid (AME), only if Ethic Committee approves it)
排除标准
- •HIV-2 co-infection
- •Hepatitis B Virus infection (positive HBs antigen)
- •Any comorbidity potentially related to a life expectancy below 12 months
- •Any condition (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
- •Pregnant women or breastfeeding women
- •Women of childbearing age that do not want to use an effective method of contraception
- •Participant under justice protection
- •Galactose/lactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (known or documented)
- •Participation to another clinical trial evaluating a new treatment/therapy
研究组 & 干预措施
Strategy TRI-BI
干预措施: Antiretroviral (Drug)
Strategy Immediate BI
干预措施: Antiretroviral (Drug)
结局指标
主要结局
To demonstrate at W48 the non-inferiority
时间窗: proportion of participants with plasma HIV-RNA <50 copies/mL at Week 48 in the 2 arms on allocated treatment (FDA snapshot approach)
To demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudine (3TC) preceded by a induction period with TDF or TAF plus FTC or 3TC plus an integrase inhibitor (INI) relative to an immediate 2-DR strategy with dolutegravir plus 3TC in HIV-infected ART naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA strictly lower than 50 000 cp/mL
次要结局
未报告次要终点