A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
2015년 9월 24일 업데이트: Bristol-Myers Squibb
A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
연구 개요
연구 유형
중재적
등록 (실제)
238
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
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California
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Beverly Hills, California, 미국, 90211
- Pacific Oaks Medical Group
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Long Beach, California, 미국, 90822
- VA Long Beach Healthcare System
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Los Angeles, California, 미국, 90036
- Peter J Ruane Md Inc
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Los Angeles, California, 미국, 90069
- Anthony M. Mills Md Inc
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Los Angeles, California, 미국, 90232
- Jeffrey Goodman Special Care Clinic
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San Diego, California, 미국, 92114
- Precision Research Institute, LLC
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San Diego, California, 미국, 92103
- UCSD AntiViral Research Center (AVRC)
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San Francisco, California, 미국, 94110
- University of California San Francisco
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado
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District of Columbia
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Washington, District of Columbia, 미국, 20010
- MedStar Washington Hospital Center
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Washington, District of Columbia, 미국, 20009
- Whitman Walker Health
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Washington, District of Columbia, 미국, 20036
- Capital Medical Associates
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Florida
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Fort Pierce, Florida, 미국, 34982
- Midway Immunology and Research Center
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Miami, Florida, 미국, 33136
- University of Miami Schiff Center for Liver Diseases
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Orlando, Florida, 미국, 32803
- Orlando Immunology Center
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Georgia
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Decatur, Georgia, 미국, 30033
- Infect. Disease Specialists
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University Health - University Hospital
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Maryland
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Baltimore, Maryland, 미국, 21229
- Digestive Disease Associates, P.A.
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Lutherville, Maryland, 미국, 21093
- Johns Hopkins University
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford Health System
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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New Mexico
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Sante Fe, New Mexico, 미국, 87505
- Southwest CARE Center
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New York
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Binghamton, New York, 미국, 13903
- Binghamton Gastroenterology Associates
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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Ohio
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Cincinnati, Ohio, 미국, 45267
- University of Cincinnati
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Oklahoma
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Tulsa, Oklahoma, 미국, 74135
- Healthcare Research Consultants
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health Science Univ
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Pennsylvania
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Allentown, Pennsylvania, 미국, 18102
- Lehigh Valley Health Network
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- The Miriam Hospital
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Providence, Rhode Island, 미국, 02905
- University Gastroenterology
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Texas
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Fort Worth, Texas, 미국, 76104
- Tarrant County Inf Dis Assoc
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Houston, Texas, 미국, 77030
- University of Texas Health Science Center at Houston
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Houston, Texas, 미국, 77004
- Cure C Consortium
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Utah
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Murray, Utah, 미국, 84123
- Clinical Research Centers Of America
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Virginia
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Richmond, Virginia, 미국, 23249
- Mcguire D V A M C
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Washington
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Seattle, Washington, 미국, 98104
- Harborview Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria:
- Patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
- Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6, as documented by positive HCV RNA at screening
- Patients who are HCV treatment-naive
- Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies discontinued or completed at least 12 weeks prior to screening
- Patients with HCV RNA ≥10,000 IU/mL at screening
- Patients with HIV-1 infection
Key Exclusion Criteria:
- Presence of AIDs-defining opportunistic infections, as defined by the Centers of Disease Control and Prevention, within 12 weeks prior to study entry
- Patients infected with HIV-2
- Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed
- Evidence of decompensated liver disease, including radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Daclatasvir + Sofosbuvir (Treatment-naive) 12 weeks
Treatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
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다른 이름들:
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실험적: Daclatasvir + Sofosbuvir (Treatment-naive) 8 weeks
Treatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks
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다른 이름들:
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실험적: Daclatasvir + Sofosbuvir (Treatment-experienced) 12 weeks
Treatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
기간: At follow-up Week 12
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SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
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At follow-up Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
기간: At follow-up Week 12
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SVR12 was defined as HCV RNA<lower limit of quantitation, target detected, or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
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At follow-up Week 12
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Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
기간: At follow-up Week 12
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SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
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At follow-up Week 12
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Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)
기간: At follow-up Week 12
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SVR12 was defined as HCV RNA levels <lower limit of quantitation, target detected or target not detected.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
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At follow-up Week 12
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Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24
기간: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
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Participants with hepatitis C virus CV) levels to be <lower limit of quantitation, TD or TND at each visit.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
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Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
기간: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
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Participants with HCV RNA levels <LLOQ, TND.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
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Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
기간: At Follow-up Week 12
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SVR is defined as hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment.
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At Follow-up Week 12
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period
기간: AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
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AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period
기간: AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
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AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.
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Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
기간: From screening up to week 24 of post treatment follow--up
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Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper
limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L
for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN
for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN
for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN
for grade 3 and >10.0*ULN for grade 4.
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From screening up to week 24 of post treatment follow--up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Luetkemeyer AF, McDonald C, Ramgopal M, Noviello S, Bhore R, Ackerman P. 12 Weeks of Daclatasvir in Combination With Sofosbuvir for HIV-HCV Coinfection (ALLY-2 Study): Efficacy and Safety by HIV Combination Antiretroviral Regimens. Clin Infect Dis. 2016 Jun 15;62(12):1489-96. doi: 10.1093/cid/ciw163. Epub 2016 Mar 29.
- Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 2월 1일
기본 완료 (실제)
2014년 10월 1일
연구 완료 (실제)
2015년 1월 1일
연구 등록 날짜
최초 제출
2014년 1월 9일
QC 기준을 충족하는 최초 제출
2014년 1월 9일
처음 게시됨 (추정)
2014년 1월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 10월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 9월 24일
마지막으로 확인됨
2015년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AI444-216
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. .