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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

238

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Geneesmiddel: Sofosbuvir
Geneesmiddel: Daclatasvir
Andere namen:
  • GBS-790052
Experimenteel: 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
Geneesmiddel: Sofosbuvir
Geneesmiddel: Daclatasvir
Andere namen:
  • GBS-790052
Experimenteel: 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
Geneesmiddel: Sofosbuvir
Geneesmiddel: Daclatasvir
Andere namen:
  • GBS-790052

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bristol-Myers Squibb

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2014

Primaire voltooiing (Werkelijk)

1 oktober 2014

Studie voltooiing (Werkelijk)

1 januari 2015

Studieregistratiedata

Eerst ingediend

9 januari 2014

Eerst ingediend dat voldeed aan de QC-criteria

9 januari 2014

Eerst geplaatst (Schatting)

10 januari 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

27 oktober 2015

Laatste update ingediend die voldeed aan QC-criteria

24 september 2015

Laatst geverifieerd

1 augustus 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AI444-216

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Locaties

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