An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 77
- 主要终点
- Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components
研究概览
简要总结
The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class.
In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.
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
- •Patient with confirmed HIV infection
- •Age ≥ 18 years
- •Written informed consent
- •Male patient or non-pregnant, non-lactating female
- •No previous treatment with any antiretroviral drugs
- •HIV-1 RNA > 1000 copies/ml
- •Indication to start an antiretroviral treatment as long as subject has also a CD4 cell count ≤ 500/mm3 either at screening or on a sample taken within 3 months before screening
- •No major IAS-USA mutations on genotypic testing at the screening visit or on any historical genotype, if available
- •Non-inclusion Criteria:
- •Woman without effective contraception method (recommended contraception during the trial is mechanical + a second method other than an oral contraceptive)
- •Pregnant or breastfeeding woman
- •Woman expecting to conceive during the study
- •HIV-2 co-infection
- •Creatinine clearance < 60 ml/mn (Cockcroft & Gault equation), alkaline phosphatase, ASAT, or ALAT ≥ 5 ULN
- •Patient with significant impairment of hepatic function, defined as serum albumin < 2.8 g/dl or INR > 1.7 or presence of ascites, in the absence of another explanation for the abnormal finding
- •CD4 > 500/mm3 at screening, except in case of symptomatic HIV disease (defined by conditions qualifying for CDC category B or C) or CD4 ≤ 500/mm3 on a sample taken within 3 months before screening.
- •Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or protease inhibitors on genotypic testing at screening
- •Mycobacteriosis under treatment
- •Malignancy requiring chemotherapy or radiotherapy
- •Positive HBs Ag
- •HCV infection for which specific treatment is ongoing or planned during the first year on trial treatment
- •Known hypersensitivity to one of the trial drugs or its excipients
- •Contraindicated concomitant treatment
- •Anticipated non-compliance with the protocol
- •Participation in another clinical trial with an on-going exclusion period at screening
- •Subject under legal guardianship or incapacitation
- •Subject, who in the opinion of the investigator, is unable to complete the study period
排除标准
- 未提供
研究组 & 干预措施
darunavir/r + tenofovir/emtricitabine
干预措施: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination) (Drug)
darunavir/r + raltegravir
干预措施: darunavir/ritonavir QD + raltegravir BID (Drug)
结局指标
主要结局
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components
时间窗: minimum 2 years
次要结局
未报告次要终点