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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

238

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: Sofosbuvir
Medicin: Daclatasvir
Andre navne:
  • BMS-790052
Eksperimentel: 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
Medicin: Sofosbuvir
Medicin: Daclatasvir
Andre navne:
  • BMS-790052
Eksperimentel: 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
Medicin: Sofosbuvir
Medicin: Daclatasvir
Andre navne:
  • BMS-790052

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

9. januar 2014

Først indsendt, der opfyldte QC-kriterier

9. januar 2014

Først opslået (Skøn)

10. januar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI444-216

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatitis C

Kliniske forsøg med Sofosbuvir

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Czech Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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