A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 698
- 试验地点
- 134
- 主要终点
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.
Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.
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
- Triple (Participant, 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 at screening
- •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 ATV
- •Normal ECG
- •Adequate renal function (eGFR calculated using the Cockcroft-Gault equation ≥ 70 mL/min)
- •Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (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 30 days following the last dose of study drug.
- •Age ≥ 18 years
- •Life expectancy ≥ 1 year
排除标准
- •A new 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)
- •Have an implanted defibrillator or pacemaker
- •Have an ECG PR interval ≥ 220 msec
- •Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
- •A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive 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 COBI, emtricitabine (FTC), tenofovir disoproxil fumarate (TDF), atazanavir (ATV), ritonavir (RTV) or subjects with any known allergies to the excipients of COBI tablets, Truvada tablets, atazanavir capsules or ritonavir tablets.
- •Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial.
- •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
ATV+RTV+FTC/TDF
RTV + COBI placebo + ATV + FTC/TDF once daily
干预措施: COBI placebo (Drug)
ATV+COBI+FTC/TDF
COBI + RTV placebo + ATV + FTC/TDF once daily
干预措施: COBI (Drug)
ATV+COBI+FTC/TDF
COBI + RTV placebo + ATV + FTC/TDF once daily
干预措施: ATV (Drug)
ATV+COBI+FTC/TDF
COBI + RTV placebo + ATV + FTC/TDF once daily
干预措施: FTC/TDF (Drug)
ATV+COBI+FTC/TDF
COBI + RTV placebo + ATV + FTC/TDF once daily
干预措施: RTV placebo (Drug)
ATV+RTV+FTC/TDF
RTV + COBI placebo + ATV + FTC/TDF once daily
干预措施: RTV (Drug)
ATV+RTV+FTC/TDF
RTV + COBI placebo + ATV + FTC/TDF once daily
干预措施: ATV (Drug)
ATV+RTV+FTC/TDF
RTV + COBI placebo + ATV + FTC/TDF once daily
干预措施: FTC/TDF (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
时间窗: Week 48
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
次要结局
- Change From Baseline in CD4 Cell Count at Week 96(Baseline to Week 96)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144(Week 144)
- Change From Baseline in CD4 Cell Count at Week 48(Baseline to Week 48)
- Change From Baseline in CD4 Cell Count at Week 144(Baseline to Week 144)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96(Week 96)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192(Week 192)
- Change From Baseline in CD4 Cell Count at Week 192(Baseline to Week 192)