A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen 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
- 279
- 试验地点
- 41
- 主要终点
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
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
- Double (Participant, Investigator)
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
- •Plasma HIV 1 RNA levels ≥ 5,000 copies/mL
- •No prior use of any approved or experimental anti-HIV drug for any length of time
- •Screening genotype report must show sensitivity to TDF and emtricitabine (FTC)
- •Normal ECG
- •Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula
- •Hepatic transaminases ≤ 2.5 x upper limit of the normal range (ULN)
- •Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- •Adequate hematologic function
- •CD4+ cell count > 50 cells/µL
- •Serum amylase ≤ 5 x ULN
- •Normal thyroid-stimulating hormone (TSH)
- •Females of childbearing potential must have a negative serum pregnancy test
- •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 drugs
- •Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
- •Female subjects who are postmenopausal must have documentation of cessation of menses for ≥ 12 months and hormonal failure
- •Female subjects who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level test at screening
- •Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 90 days following discontinuation of investigational medicinal product
- •Age ≥ 18 years
- •Life expectancy ≥ 1 year
排除标准
- •New AIDS-defining condition diagnosed within the 30 days prior to screening
- •Hepatitis B surface Antigen positive
- •Hepatitis C Antibody positive
- •Proven acute hepatitis in the 30 days prior to study entry
- •Subjects experiencing decompensated cirrhosis
- •Females who are breastfeeding
- •Positive serum pregnancy test (female of childbearing potential)
- •Have an implanted defibrillator or pacemaker
- •Receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir and cobicistat
- •Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
- •Current alcohol or substance
- •History of or ongoing malignancy (including untreated carcinoma in-situ) 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
- •Participation in any other clinical trial without prior approval is prohibited while participating in this trial
- •Medications contraindicated for use with emtricitabine or tenofovir disoproxil fumarate
- •Any known allergies to the excipients of E/C/F/TAF or E/C/F/TDF FDC tablets
- •Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
E/C/F/TAF
E/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks
干预措施: E/C/F/TAF (Drug)
E/C/F/TAF
E/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks
干预措施: E/C/F/TDF Placebo (Drug)
E/C/F/TDF
E/C/F/TDF plus E/C/F/TAF placebo for at least 48 weeks
干预措施: E/C/F/TDF (Drug)
E/C/F/TDF
E/C/F/TDF plus E/C/F/TAF placebo for at least 48 weeks
干预措施: E/C/F/TAF Placebo (Drug)
E/C/F/TAF Open-Label
Following study unblinding, participants from the E/C/F/TAF and E/C/F/TDF arms may have the option to receive E/C/F/TAF during an open-label extension phase.
Also, participants who are actively participating in a Gilead-sponsored study of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate and receive E/C/F/TAF in this open-label extension phase.
干预措施: E/C/F/TAF (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
时间窗: Week 24
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
次要结局
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48(Week 48)
- Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48(Baseline; Weeks 24 and 48)
- Change From Baseline in CD4+ Cell Count at Weeks 24 and 48(Baseline; Weeks 24 and 48)