A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
24. září 2015 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
238
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama at Birmingham
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California
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Beverly Hills, California, Spojené státy, 90211
- Pacific Oaks Medical Group
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Long Beach, California, Spojené státy, 90822
- VA Long Beach Healthcare System
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Los Angeles, California, Spojené státy, 90036
- Peter J Ruane Md Inc
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Los Angeles, California, Spojené státy, 90069
- Anthony M. Mills Md Inc
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Los Angeles, California, Spojené státy, 90232
- Jeffrey Goodman Special Care Clinic
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San Diego, California, Spojené státy, 92114
- Precision Research Institute, LLC
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San Diego, California, Spojené státy, 92103
- UCSD AntiViral Research Center (AVRC)
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San Francisco, California, Spojené státy, 94110
- University of California San Francisco
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Colorado
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Aurora, Colorado, Spojené státy, 80045
- University of Colorado
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District of Columbia
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Washington, District of Columbia, Spojené státy, 20010
- MedStar Washington Hospital Center
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Washington, District of Columbia, Spojené státy, 20009
- Whitman Walker Health
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Washington, District of Columbia, Spojené státy, 20036
- Capital Medical Associates
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Florida
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Fort Pierce, Florida, Spojené státy, 34982
- Midway Immunology and Research Center
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Miami, Florida, Spojené státy, 33136
- University of Miami Schiff Center for Liver Diseases
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Orlando, Florida, Spojené státy, 32803
- Orlando Immunology Center
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Georgia
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Decatur, Georgia, Spojené státy, 30033
- Infect. Disease Specialists
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
- Indiana University Health - University Hospital
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Maryland
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Baltimore, Maryland, Spojené státy, 21229
- Digestive Disease Associates, P.A.
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Lutherville, Maryland, Spojené státy, 21093
- Johns Hopkins University
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Michigan
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Detroit, Michigan, Spojené státy, 48202
- Henry Ford Health System
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Missouri
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Saint Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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New Mexico
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Sante Fe, New Mexico, Spojené státy, 87505
- Southwest CARE Center
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New York
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Binghamton, New York, Spojené státy, 13903
- Binghamton Gastroenterology Associates
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New York, New York, Spojené státy, 10029
- Icahn School of Medicine at Mount Sinai
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Ohio
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Cincinnati, Ohio, Spojené státy, 45267
- University of Cincinnati
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Oklahoma
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Tulsa, Oklahoma, Spojené státy, 74135
- Healthcare Research Consultants
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Oregon
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Portland, Oregon, Spojené státy, 97239
- Oregon Health Science Univ
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Pennsylvania
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Allentown, Pennsylvania, Spojené státy, 18102
- Lehigh Valley Health Network
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02906
- The Miriam Hospital
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Providence, Rhode Island, Spojené státy, 02905
- University Gastroenterology
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Texas
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Fort Worth, Texas, Spojené státy, 76104
- Tarrant County Inf Dis Assoc
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Houston, Texas, Spojené státy, 77030
- University of Texas Health Science Center at Houston
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Houston, Texas, Spojené státy, 77004
- Cure C Consortium
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Utah
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Murray, Utah, Spojené státy, 84123
- Clinical Research Centers Of America
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Virginia
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Richmond, Virginia, Spojené státy, 23249
- Mcguire D V A M C
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Washington
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Seattle, Washington, Spojené státy, 98104
- Harborview Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Ostatní jména:
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Experimentální: 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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Ostatní jména:
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Experimentální: 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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Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2014
Primární dokončení (Aktuální)
1. října 2014
Dokončení studie (Aktuální)
1. ledna 2015
Termíny zápisu do studia
První předloženo
9. ledna 2014
První předloženo, které splnilo kritéria kontroly kvality
9. ledna 2014
První zveřejněno (Odhad)
10. ledna 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
27. října 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. září 2015
Naposledy ověřeno
1. srpna 2015
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- RNA virové infekce
- Virová onemocnění
- Infekce
- Infekce přenášené krví
- Přenosné nemoci
- Onemocnění jater
- Infekce Flaviviridae
- Hepatitida, virová, lidská
- Enterovirové infekce
- Infekce Picornaviridae
- Hepatitida
- Žloutenka typu A
- Hepatitida C
- Antiinfekční látky
- Antivirová činidla
- Sofosbuvir
Další identifikační čísla studie
- AI444-216
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .