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A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.

24. September 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

238

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35294
        • University of Alabama at Birmingham
    • California
      • Beverly Hills, California, Vereinigte Staaten, 90211
        • Pacific Oaks Medical Group
      • Long Beach, California, Vereinigte Staaten, 90822
        • VA Long Beach Healthcare System
      • Los Angeles, California, Vereinigte Staaten, 90036
        • Peter J Ruane Md Inc
      • Los Angeles, California, Vereinigte Staaten, 90069
        • Anthony M. Mills Md Inc
      • Los Angeles, California, Vereinigte Staaten, 90232
        • Jeffrey Goodman Special Care Clinic
      • San Diego, California, Vereinigte Staaten, 92114
        • Precision Research Institute, LLC
      • San Diego, California, Vereinigte Staaten, 92103
        • UCSD AntiViral Research Center (AVRC)
      • San Francisco, California, Vereinigte Staaten, 94110
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • University of Colorado
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20010
        • MedStar Washington Hospital Center
      • Washington, District of Columbia, Vereinigte Staaten, 20009
        • Whitman Walker Health
      • Washington, District of Columbia, Vereinigte Staaten, 20036
        • Capital Medical Associates
    • Florida
      • Fort Pierce, Florida, Vereinigte Staaten, 34982
        • Midway Immunology and Research Center
      • Miami, Florida, Vereinigte Staaten, 33136
        • University of Miami Schiff Center for Liver Diseases
      • Orlando, Florida, Vereinigte Staaten, 32803
        • Orlando Immunology Center
    • Georgia
      • Decatur, Georgia, Vereinigte Staaten, 30033
        • Infect. Disease Specialists
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46202
        • Indiana University Health - University Hospital
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21229
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, Vereinigte Staaten, 21093
        • Johns Hopkins University
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, Vereinigte Staaten, 63110
        • Washington University School of Medicine
    • New Mexico
      • Sante Fe, New Mexico, Vereinigte Staaten, 87505
        • Southwest CARE Center
    • New York
      • Binghamton, New York, Vereinigte Staaten, 13903
        • Binghamton Gastroenterology Associates
      • New York, New York, Vereinigte Staaten, 10029
        • Icahn School of Medicine at Mount Sinai
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45267
        • University of Cincinnati
    • Oklahoma
      • Tulsa, Oklahoma, Vereinigte Staaten, 74135
        • Healthcare Research Consultants
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Oregon Health Science Univ
    • Pennsylvania
      • Allentown, Pennsylvania, Vereinigte Staaten, 18102
        • Lehigh Valley Health Network
    • Rhode Island
      • Providence, Rhode Island, Vereinigte Staaten, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, Vereinigte Staaten, 02905
        • University Gastroenterology
    • Texas
      • Fort Worth, Texas, Vereinigte Staaten, 76104
        • Tarrant County Inf Dis Assoc
      • Houston, Texas, Vereinigte Staaten, 77030
        • University of Texas Health Science Center at Houston
      • Houston, Texas, Vereinigte Staaten, 77004
        • Cure C Consortium
    • Utah
      • Murray, Utah, Vereinigte Staaten, 84123
        • Clinical Research Centers Of America
    • Virginia
      • Richmond, Virginia, Vereinigte Staaten, 23249
        • Mcguire D V A M C
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98104
        • Harborview Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Arzneimittel: Sofosbuvir
Arzneimittel: Daclatasvir
Andere Namen:
  • BMS-790052
Experimental: 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
Arzneimittel: Sofosbuvir
Arzneimittel: Daclatasvir
Andere Namen:
  • BMS-790052
Experimental: 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
Arzneimittel: Sofosbuvir
Arzneimittel: Daclatasvir
Andere Namen:
  • BMS-790052

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Zeitfenster: At follow-up Week 12
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.
At follow-up Week 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Zeitfenster: At follow-up Week 12
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.
At follow-up Week 12
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Zeitfenster: At follow-up Week 12
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.
At follow-up Week 12
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)
Zeitfenster: At follow-up Week 12
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.
At follow-up Week 12
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
Zeitfenster: Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
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.
Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Zeitfenster: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
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.
At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
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)
Zeitfenster: At Follow-up Week 12
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.
At Follow-up Week 12
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
Zeitfenster: 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)
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.
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)
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
Zeitfenster: 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.
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.
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.
Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Zeitfenster: From screening up to week 24 of post treatment follow--up
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.
From screening up to week 24 of post treatment follow--up

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bristol-Myers Squibb

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2014

Primärer Abschluss (Tatsächlich)

1. Oktober 2014

Studienabschluss (Tatsächlich)

1. Januar 2015

Studienanmeldedaten

Zuerst eingereicht

9. Januar 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Januar 2014

Zuerst gepostet (Schätzen)

10. Januar 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

27. Oktober 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. September 2015

Zuletzt verifiziert

1. August 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AI444-216

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