- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02071082
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
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85012
- Spectrum Medical Group
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California
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Beverly Hills, California, 미국, 90211
- AHF Research Center
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Los Angeles, California, 미국, 90036
- Peter J. Ruane MD, Inc.
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Los Angeles, California, 미국, 90069
- Anthony Mills MD, Inc
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District of Columbia
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Washington, District of Columbia, 미국, 20009
- Whitman Walker Health
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Florida
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Clearwater, Florida, 미국, 33765
- Barry M. Rodwick MD
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Fort Lauderdale, Florida, 미국, 33316
- Gary J Richmond M.D.,P.A.
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Fort Pierce, Florida, 미국, 34982
- Midway Immunology and Research Center
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Miami Beach, Florida, 미국, 33139
- AIDS Health Foundation/WPA
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Vero Beach, Florida, 미국, 32960
- AIDS Research and Treatment Center of the Treasure Coast
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West Palm Beach, Florida, 미국, 33401
- Triple O Research Institute PA
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Michigan
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Berkley, Michigan, 미국, 48072
- Be Well Medical Center PC
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Missouri
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Kansas City, Missouri, 미국, 64111
- KC Care Clinic
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Saint Louis, Missouri, 미국, 63139
- Southampton Healthcare, Inc.
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New Mexico
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Santa Fe, New Mexico, 미국, 87505
- Southwest CARE Center
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Texas
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Austin, Texas, 미국, 78705
- Central Texas Clinical Research
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Bellaire, Texas, 미국
- St. Hope Foundation
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Dallas, Texas, 미국, 75246
- North Texas Infectious Diseases Consultants
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Houston, Texas, 미국, 77004
- Therapeutic Concepts
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Houston, Texas, 미국, 77098
- Gordon E. Crofoot MD PA
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Washington
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Seattle, Washington, 미국, 98104
- Peter Shalit MD
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Tokyo
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Shinjuku-ku, Tokyo, 일본, 1628655
- Center Hospital of the National Center for Global Health and Medicine
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Ontario
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Toronto, Ontario, 캐나다, M5G 2N2
- University Health Network/Toronto General Hospital
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Toronto, Ontario, 캐나다, M5G1K2
- Maple Leaf Research/Maple Leaf Medical Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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
다른 이름들:
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실험적: 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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
기간: 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.
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Week 24
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Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL
기간: Week 48
|
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.
|
Week 48
|
Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL
기간: Week 48
|
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
|
Baseline; Week 24
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Change From Baseline in FibroTest® Score at Week 48
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- GS-US-292-1249
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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