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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01718301
First received: October 25, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
HCV and HIV Seropositive Coinfection
Drug: boceprevir
Drug: Ribavirin
Drug: Peginterferon alfa-2a
Drug: Peginterferon alfa-2b
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Achievement of sustained virological response (SVR) at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Achievement of sustained virological response at weeks 2,4,8,12. [ Time Frame: Weeks 2, 4, 8, 12 ] [ Designated as safety issue: No ]
    The proportion of subjects with virological response (eg. undetectable HCV-RNA at Weeks 2, 4, 8, or 12) in subjects who achieve SVR.

  • The proportion of subjects with undetectable HCV-RNA at FW 12. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The proportion of subjects with undetectable HCV-RNA at FW 12.

  • The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization. [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.

  • Number of adverse events [ Time Frame: From baseline to study completion (up to 72 weeks) ] [ Designated as safety issue: Yes ]
    Safety: number of adverse events

  • Resistance of HCV after boceprevir (BOC) containing regimen [ Time Frame: whenever resistance occurs during the study (from week 12 until the date the resistance occurs, assessed up to 72 weeks) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 128
Study Start Date: March 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: boceprevir + ribavirin + peginterferon
boceprevir 800 mg three times a day (v.o.) in combination with peginterferon (alfa-2b or alfa-2a) and ribavirin
Drug: boceprevir Drug: Ribavirin Drug: Peginterferon alfa-2a Drug: Peginterferon alfa-2b

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
    2. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718301

Contacts
Contact: Anna Cruceta, MD 932275400 ext 4380 acruceta@clinic.ub.es

Sponsors and Collaborators
Anna Cruceta
Investigators
Principal Investigator: Josep Mallolas, MD Hospital Clínic i Provincial de Barcelona
  More Information

No publications provided

Responsible Party: Anna Cruceta, Clinical Research manager, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01718301     History of Changes
Other Study ID Numbers: BOC-HIV
Study First Received: October 25, 2012
Last Updated: October 31, 2012
Health Authority: Spain: Spanish Agency of Medicines and Medicinal Devices

Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
HCV
HIV
Coinfection

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Coinfection
Infection
Virus Diseases
Parasitic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ribavirin
Peginterferon alfa-2a
Peginterferon alfa-2b
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014