Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults
A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults
This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults.
Participants will be enrolled into two cohorts:
- Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive
- Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G 2N2
- University Health Network/Toronto General Hospital
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Toronto、Ontario、加拿大、M5G1K2
- Maple Leaf Research/Maple Leaf Medical Clinic
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Tokyo
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Shinjuku-ku、Tokyo、日本、1628655
- Center Hospital of the National Center for Global Health and Medicine
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Arizona
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Phoenix、Arizona、美国、85012
- Spectrum Medical Group
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California
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Beverly Hills、California、美国、90211
- AHF Research Center
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Los Angeles、California、美国、90036
- Peter J. Ruane MD, Inc.
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Los Angeles、California、美国、90069
- Anthony Mills MD, Inc
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District of Columbia
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Washington、District of Columbia、美国、20009
- Whitman Walker Health
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Florida
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Clearwater、Florida、美国、33765
- Barry M. Rodwick MD
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Fort Lauderdale、Florida、美国、33316
- Gary J Richmond M.D.,P.A.
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Fort Pierce、Florida、美国、34982
- Midway Immunology and Research Center
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Miami Beach、Florida、美国、33139
- AIDS Health Foundation/WPA
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Vero Beach、Florida、美国、32960
- AIDS Research and Treatment Center of the Treasure Coast
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West Palm Beach、Florida、美国、33401
- Triple O Research Institute PA
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Michigan
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Berkley、Michigan、美国、48072
- Be Well Medical Center PC
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Missouri
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Kansas City、Missouri、美国、64111
- KC Care Clinic
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Saint Louis、Missouri、美国、63139
- Southampton Healthcare, Inc.
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New Mexico
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Santa Fe、New Mexico、美国、87505
- Southwest CARE Center
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Texas
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Austin、Texas、美国、78705
- Central Texas Clinical Research
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Bellaire、Texas、美国
- St. Hope Foundation
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Dallas、Texas、美国、75246
- North Texas Infectious Diseases Consultants
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Houston、Texas、美国、77004
- Therapeutic Concepts
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Houston、Texas、美国、77098
- Gordon E. Crofoot MD PA
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Washington
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Seattle、Washington、美国、98104
- Peter Shalit MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
Both Cohorts 1 and 2:
- The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- HIV/HBV co-infected adult males and non-pregnant and non-lactating females
No evidence of hepatocellular carcinoma (HCC) or clinical or imaging evidence of cirrhosis (ascites, variceal bleeding, encephalopathy).
--- Subjects should have documentation of an abdominal ultrasound in the 12 months prior to screening, or an abdominal ultrasound at screening, demonstrating the absence of cirrhosis and HCC.
- Acute Hepatitis A virus (HAV) immunoglobulin M (IgM) negative
- Hepatitis C virus (HCV) Ab negative, or HCV Ab positive with negative HCV RNA
- Hepatitis D virus (HDV) Ab negative, or HDV Ab positive with negative HDV RNA
- Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula
- CD4+ count of > 200 cells/μL
Chronic HBV infection as defined by
- HBsAg positive for ≥ 6 months Or
- HBsAg positive at screening and either hepatitis B e antigen (HBeAg) or HBV DNA positive ≥ 6 months Or
At screening: positive total hepatitis B core antibody (HBcAb) and negative immunoglobulin M antibody to hepatitis B core antigen (HBcIgM) antibody, and
- HBsAg positive, or
- HBeAg positive, or
- HBV DNA positive
Cohort 1 (HIV and HBV treatment naive) only:
- No current or prior anti-HIV treatment, including antiretroviral medications received for prevention (PrEP), or post exposure prophylaxis (PEP)
- No current or prior anti-HBV treatment
- Plasma HIV-1 RNA level ≥ 500 copies/mL at screening
- Screening HBV DNA ≥ 3 log10 IU/mL and < 9 log10 IU/mL
Cohort 2 (HIV suppressed) only:
- Receiving current antiretroviral regimen for at least 4 consecutive months
- No current or prior regimen containing 3 active anti-HBV agents (i.e. cannot be on tenofovir alafenamide (TDF)/emtricitabine (FTC)/Entecavir or TDF/lamivudine(3TC)/Entecavir)
- Maintained plasma HIV-1 RNA < 50 copies/mL for 6 consecutive months prior to and at the time of the screening visit. Unconfirmed virologic evaluation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
- Documented positive HIV antibody test
- Screening HBV DNA < 9 log10 IU/mL
Key Exclusion Criteria:
- Females who are breastfeeding
- Positive serum pregnancy test (female of childbearing potential)
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use
- A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive carcinoma.
- Received solid organ or bone marrow transplant
- Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
- Significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses), or multiple bone fractures
- Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
- Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone, and dexamethasone)
- 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
- Investigational agents (unless approved by Gilead Sciences). Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:HIV treatment-naive and HBV treatment-naive
HIV/HBV coinfected participants who are HIV treatment-naive and HBV treatment-naive will receive E/C/F/TAF for 48 weeks.
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E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
其他名称:
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实验性的:HIV-suppressed
HIV/HBV coinfected participants who are HIV-suppressed will receive E/C/F/TAF for 48 weeks.
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E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
大体时间:Week 24
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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.
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Week 24
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Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
大体时间:Week 24
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The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.
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Week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
大体时间:Week 48
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The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 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.
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Week 48
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Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
大体时间:Week 48
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The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.
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Week 48
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Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24
大体时间:Baseline; Week 24
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ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
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Baseline; Week 24
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Percentage of Participants With Normalized ALT at Week 48
大体时间:Baseline; Week 48
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ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.
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Baseline; Week 48
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Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24
大体时间:Baseline; Week 24
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Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value.
Missing = excluded method.
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Baseline; Week 24
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Percentage of Participants With Seroconversion to Anti-HBs at Week 48
大体时间:Baseline; Week 48
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Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value.
Missing = excluded method.
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Baseline; Week 48
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Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24
大体时间:Baseline; Week 24
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Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value.
Missing = excluded method.
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Baseline; Week 24
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Percentage of Participants With Seroconversion to Anti-HBe at Week 48
大体时间:Baseline; Week 48
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Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value.
Missing = excluded method.
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Baseline; Week 48
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Change From Baseline in FibroTest® Score at Week 24
大体时间:Baseline; Week 24
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The FibroTest® score is used to assess liver fibrosis.
Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
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Baseline; Week 24
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Change From Baseline in FibroTest® Score at Week 48
大体时间:Baseline; Week 48
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The FibroTest® score is used to assess liver fibrosis.
Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.
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Baseline; Week 48
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GS-US-292-1249
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
艾滋病病毒的临床试验
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Hospital Clinic of Barcelona完全的
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Centers for Disease Control and PreventionGilead Sciences; CDC Foundation完全的
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Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
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Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
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Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的
E/C/F/TAF的临床试验
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Gilead Sciences完全的艾滋病毒感染 | 艾滋病病毒美国, 英国, 瑞典, 法国, 波多黎各, 荷兰, 意大利, 葡萄牙, 加拿大, 墨西哥, 多明尼加共和国
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Gilead Sciences完全的艾滋病毒感染 | 艾滋病病毒美国, 西班牙, 瑞士, 加拿大, 泰国, 波多黎各, 澳大利亚, 奥地利, 比利时, 意大利, 日本, 英国
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Gilead Sciences完全的艾滋病毒感染 | 获得性免疫缺陷综合症美国, 波多黎各
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Gilead Sciences主动,不招人艾滋病毒感染 | 获得性免疫缺陷综合症(艾滋病)美国, 泰国, 乌干达, 南非, 津巴布韦
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Gilead Sciences完全的HIV-1 感染俄罗斯联邦, 美国, 泰国, 乌干达, 波多黎各, 多明尼加共和国
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University of California, Los AngelesGilead Sciences完全的
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Gilead Sciences完全的艾滋病毒感染 | 获得性免疫缺陷综合症美国, 泰国, 法国, 乌干达, 英国, 比利时, 葡萄牙, 墨西哥, 多明尼加共和国, 意大利, 波多黎各, 俄罗斯联邦
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Gilead Sciences完全的
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Gilead Sciences完全的艾滋病毒感染 | 艾滋病病毒加拿大, 美国, 西班牙, 波多黎各, 法国, 瑞士, 澳大利亚, 德国, 英国, 瑞典, 巴西, 奥地利, 泰国, 荷兰, 比利时, 多明尼加共和国, 葡萄牙, 意大利, 丹麦, 墨西哥