A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla® (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 30
- 主要终点
- The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
研究概览
简要总结
The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs.
Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
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
- •Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
- •No prior use of any approved or experimental anti-HIV drug
- •Normal electrocardiogram (ECG)
- •Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
- •Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- •Adequate hematologic function
- •Cluster determinant 4 (CD4) cell count > 50 cells/µL
- •Serum amylase ≤ 1.5 x ULN
- •Normal thyroid-stimulating hormone
- •Negative serum pregnancy test (for females of childbearing potential only)
- •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 drugs
- •Life expectancy ≥ 1 year
- •Ability to understand and sign a written informed consent form
排除标准
- •New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
- •Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
- •Hepatitis B surface antigen positive
- •Hepatitis C antibody positive
- •Participants experiencing cirrhosis
- •Participants experiencing ascites
- •Participants experiencing encephalopathy
- •Females who are breastfeeding
- •Positive serum pregnancy test (for females of childbearing potential)
- •Vaccinated within 90 days of study dosing
- •History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
- •Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
- •Prolonged QTcF interval at screening
- •PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening
- •QRS ≥ 120 msec on ECG at screening
- •Implanted defibrillator or pacemaker
- •Participants receiving ongoing therapy with any disallowed medications
- •Current alcohol or substance use judged to potentially interfere with participant study compliance
- •History of or ongoing malignancy (including untreated carcinoma in situ) 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
- •Participation in any other clinical trial without prior approval
- •Medications contraindicated for use with EFV, EVG, COBI, FTC, or TDF
- •Any known allergies to the excipients of Atripla or Stribild tablets
- •Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements
研究组 & 干预措施
Stribild
干预措施: Stribild (Drug)
Atripla
干预措施: Atripla (Drug)
结局指标
主要结局
The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
时间窗: Week 24
The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.
次要结局
- The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48(Week 48)
- Change From Baseline in HIV-1 RNA (log_10 Copies/mL)(Baseline to Weeks 24 and 48)
- Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24(Baseline to Week 24)
- Change From Baseline in CD4 Cell Count at Week 48(Baseline to Week 48)
- The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL(Baseline to Weeks 24 and 48)