A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
24 сентября 2015 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
238
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 35294
- University of Alabama at Birmingham
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California
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Beverly Hills, California, Соединенные Штаты, 90211
- Pacific Oaks Medical Group
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Long Beach, California, Соединенные Штаты, 90822
- VA Long Beach Healthcare System
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Los Angeles, California, Соединенные Штаты, 90036
- Peter J Ruane Md Inc
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Los Angeles, California, Соединенные Штаты, 90069
- Anthony M. Mills Md Inc
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Los Angeles, California, Соединенные Штаты, 90232
- Jeffrey Goodman Special Care Clinic
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San Diego, California, Соединенные Штаты, 92114
- Precision Research Institute, LLC
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San Diego, California, Соединенные Штаты, 92103
- UCSD AntiViral Research Center (AVRC)
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San Francisco, California, Соединенные Штаты, 94110
- University of California San Francisco
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Colorado
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Aurora, Colorado, Соединенные Штаты, 80045
- University of Colorado
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District of Columbia
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Washington, District of Columbia, Соединенные Штаты, 20010
- MedStar Washington Hospital Center
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Washington, District of Columbia, Соединенные Штаты, 20009
- Whitman Walker Health
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Washington, District of Columbia, Соединенные Штаты, 20036
- Capital Medical Associates
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Florida
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Fort Pierce, Florida, Соединенные Штаты, 34982
- Midway Immunology and Research Center
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Miami, Florida, Соединенные Штаты, 33136
- University of Miami Schiff Center for Liver Diseases
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Orlando, Florida, Соединенные Штаты, 32803
- Orlando Immunology Center
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Georgia
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Decatur, Georgia, Соединенные Штаты, 30033
- Infect. Disease Specialists
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46202
- Indiana University Health - University Hospital
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21229
- Digestive Disease Associates, P.A.
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Lutherville, Maryland, Соединенные Штаты, 21093
- Johns Hopkins University
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Michigan
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Detroit, Michigan, Соединенные Штаты, 48202
- Henry Ford Health System
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63110
- Washington University School of Medicine
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New Mexico
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Sante Fe, New Mexico, Соединенные Штаты, 87505
- Southwest CARE Center
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New York
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Binghamton, New York, Соединенные Штаты, 13903
- Binghamton Gastroenterology Associates
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New York, New York, Соединенные Штаты, 10029
- Icahn School of Medicine at Mount Sinai
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45267
- University of Cincinnati
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Oklahoma
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Tulsa, Oklahoma, Соединенные Штаты, 74135
- Healthcare Research Consultants
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Oregon
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Portland, Oregon, Соединенные Штаты, 97239
- Oregon Health Science Univ
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Pennsylvania
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Allentown, Pennsylvania, Соединенные Штаты, 18102
- Lehigh Valley Health Network
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02906
- The Miriam Hospital
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Providence, Rhode Island, Соединенные Штаты, 02905
- University Gastroenterology
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Texas
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Fort Worth, Texas, Соединенные Штаты, 76104
- Tarrant County Inf Dis Assoc
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Houston, Texas, Соединенные Штаты, 77030
- University of Texas Health Science Center at Houston
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Houston, Texas, Соединенные Штаты, 77004
- Cure C Consortium
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Utah
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Murray, Utah, Соединенные Штаты, 84123
- Clinical Research Centers Of America
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Virginia
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Richmond, Virginia, Соединенные Штаты, 23249
- Mcguire D V A M C
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Washington
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Seattle, Washington, Соединенные Штаты, 98104
- Harborview Medical Center
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Другие имена:
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Экспериментальный: 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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Другие имена:
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Экспериментальный: 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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Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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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)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 февраля 2014 г.
Первичное завершение (Действительный)
1 октября 2014 г.
Завершение исследования (Действительный)
1 января 2015 г.
Даты регистрации исследования
Первый отправленный
9 января 2014 г.
Впервые представлено, что соответствует критериям контроля качества
9 января 2014 г.
Первый опубликованный (Оценивать)
10 января 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
27 октября 2015 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
24 сентября 2015 г.
Последняя проверка
1 августа 2015 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания пищеварительной системы
- РНК-вирусные инфекции
- Вирусные заболевания
- Инфекции
- Инфекции, передающиеся через кровь
- Передающиеся заболевания
- Заболевания печени
- Флавивирусные инфекции
- Гепатит, Вирусный, Человеческий
- Энтеровирусные инфекции
- Пикорнавирусные инфекции
- Гепатит
- Гепатит А
- Гепатит С
- Противоинфекционные агенты
- Противовирусные агенты
- Софосбувир
Другие идентификационные номера исследования
- AI444-216
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .