- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01718301
HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin (BOC-HIV)
8 juli 2015 uppdaterad av: Anna Cruceta
A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin Eudra CT2012-003984-23
The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
128
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Barcelona, Spanien, 08036
- Hospital Clinic i Provincial de Barcelona
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- For inclusion in the study, subjects must have a qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen.
- Subject must have previously documented chronic hepatitis C (CHC) genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the screening visit must confirm genotype 1 infection and be ≥10,000 IU/mL.
Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:
- No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
- Cirrhosis. No specific length of time would be requested.
- All patients with cirrhosis must have an ultrasound 6 month within of screening visit.
- Patients must be on stable antiretroviral therapy including a CD4 cell count of more than 100 per mm3 and a HIV plasmatic viral load undetectable (it is < 50 copies/mL) for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least during the last 3 months).
- Subject must be ≥18 years of age.
- HIV treatment should not contain efavirenz (EFV), nevirapine (NVP), etravirine (ETV), didanosine (ddI), stavudine (d4T), zidovudine (AZT), or HIV protease inhibitors.
- Subject must weight between 40 kg and 125 kg.
- Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug.
- Subjects must be willing to give written informed consent and by investigator opinion be able to follow the protocol visit design.
Exclusion Criteria:
- Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
- Patients chronically infected with HCV genotype other than 1
- CD4 cell count < 100 cel/mm3.
- Plasma HIV RNA more than 50 copies/mL
- Platelet count less than 80.000 /mm3
- Subjects who required discontinuation of previous interferon or ribavirin regimen for a severe adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
- Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
- Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
- Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
- History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
- Evidence of decompensate liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
- Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
- Unstable or untreated pre-existing psychiatric condition.
- Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
- Any current evidence of substance abuse of alcohol or other drugs.
- Subjects receiving opioid agonist substitution therapy but not enrolled in an opiate substitution maintenance program.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: boceprevir + ribavirin + peginterferon
boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Achievement of sustained virological response (SVR) at week 24
Tidsram: Week 24
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The primary efficacy endpoint is the achievement of SVR, defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24.
If a subject is missing FW 24 data and has undetectable HCV-RNA level at FW 12, the subject would be considered an SVR.
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Week 24
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Achievement of sustained virological response at weeks 2,4,8,12.
Tidsram: Weeks 2, 4, 8, 12
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The proportion of subjects with virological response (eg.
undetectable HCV-RNA at Weeks 2, 4, 8, or 12) in subjects who achieve SVR.
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Weeks 2, 4, 8, 12
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The proportion of subjects with undetectable HCV-RNA at FW 12.
Tidsram: Week 12
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The proportion of subjects with undetectable HCV-RNA at FW 12.
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Week 12
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The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.
Tidsram: Week 72
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The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.
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Week 72
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Number of adverse events
Tidsram: From baseline to study completion (up to 72 weeks)
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Safety: number of adverse events
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From baseline to study completion (up to 72 weeks)
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Resistance of HCV after boceprevir (BOC) containing regimen
Tidsram: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)
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Resistance of HCV after boceprevir containing regimen.
Blood samples will be collected at baseline and after HCV virological failure and resistance analysis will be done at the end of the study in a single Center (Hospital Clínic-Barcelona).
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whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Josep Mallolas, MD, Hospital Clinic i Provincial de Barcelona
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2013
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 juni 2015
Studieregistreringsdatum
Först inskickad
25 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
30 oktober 2012
Första postat (Uppskatta)
31 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
9 juli 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juli 2015
Senast verifierad
1 juli 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- RNA-virusinfektioner
- Virussjukdomar
- Blodburna infektioner
- Sjukdomsegenskaper
- Leversjukdomar
- Flaviviridae-infektioner
- Hepatit, Viral, Human
- Enterovirusinfektioner
- Picornaviridae-infektioner
- Hepatit, kronisk
- Infektioner
- Smittsamma sjukdomar
- Hepatit
- Hepatit A
- Hepatit C
- Hepatit C, kronisk
- Saminfektion
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Antimetaboliter
- Ribavirin
- Peginterferon alfa-2a
- Peginterferon alfa-2b
Andra studie-ID-nummer
- BOC-HIV
- 2012-003984-23 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på HIV-infektioner
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Institut PasteurRekrytering
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Duke UniversityAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Förenta staterna
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Catholic University of the Sacred HeartAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
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The University of Texas Health Science Center,...EurofinsAvslutadOdontogen Deep Space Neck InfectionFörenta staterna
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Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekryteringCentral Line-associated Bloodstream Infection (CLABSI)Nederländerna
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Johns Hopkins UniversityAvslutadCLABSI - Central Line Associated Bloodstream InfectionFörenta staterna
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National Taiwan University Hospital Hsin-Chu BranchAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
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National Taiwan University HospitalAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
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Kliniska prövningar på boceprevir
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Merck Sharp & Dohme LLCAvslutad
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Indiana UniversityMerck Sharp & Dohme LLCAvslutad
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Erasmus Medical CenterRadboud University Medical Center; University Medical Center Groningen; Maastricht... och andra samarbetspartnersAvslutad
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GlaxoSmithKlineAvslutadTrombocytopeniFörenta staterna
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St Stephens Aids TrustUniversity of Turin, Italy; University of LiverpoolAvslutad
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Arrowhead Regional Medical CenterAvslutadHepatit C-infektionFörenta staterna
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Merck Sharp & Dohme LLCAvslutad
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Merck Sharp & Dohme LLCAvslutad
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Hoffmann-La RocheAvslutadHepatit C, kroniskFrankrike, Förenta staterna, Kanada, Tyskland, Spanien, Italien, Puerto Rico