NCT01095796已完成3 期
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 707
- 试验地点
- 102
- 主要终点
- The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
研究概览
简要总结
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
- •No prior use of any approved or investigational antiretroviral drug for any length of time
- •Screening genotype report must show sensitivity to FTC, TDF, and EFV
- •Normal electrocardiogram (ECG)
- •Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula)
- •Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 5 x the upper limit of the normal range (ULN)
- •Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- •Adequate hematologic function
- •Serum amylase ≤ 5 x ULN
- •Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug
- •Age ≥ 18 years
- •Life expectancy ≥ 1 year
排除标准
- •A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
- •Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C
- •Subjects experiencing decompensated cirrhosis
- •Females who are breastfeeding
- •Positive serum pregnancy test (female of childbearing potential)
- •Implanted defibrillator or pacemaker
- •Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
- •History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
- •Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
- •Medications contraindicated for use with EVG, COBI, FTC, EFV, or TDF; or subjects with any known allergies to the excipients of Stribild or Atripla tablets
- •Participation in any other clinical trial without prior approval
- •Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
研究组 & 干预措施
Stribild
Experimental
Stribild plus placebo to match Atripla
干预措施: Stribild (Drug)
Stribild
Experimental
Stribild plus placebo to match Atripla
干预措施: Atripla Placebo (Drug)
Atripla
Active Comparator
Atripla plus placebo to match Stribild
干预措施: Atripla (Drug)
Atripla
Active Comparator
Atripla plus placebo to match Stribild
干预措施: Stribild Placebo (Drug)
结局指标
主要结局
The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
时间窗: Week 48
次要结局
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96(Week 96)
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192(Week 192)
- The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48(Week 48)
- The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144(Week 144)
- The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192(Baseline; Weeks 48, 96, 144, and 192)
- The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm(Week 48)
研究者
研究点 (102)
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