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Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C (HIVCOBOC-RGT)

Primary Purpose

Hepatitis C, Chronic, HIV

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Pegylated interferon alpha-2a
Ribavirin
Boceprevir
Sponsored by
Markus Peck-Radosavljevic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Boceprevir, HIV/HCV-coinfection, HIV/HCV coinfection, HIV/HCV, Response-guided therapy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed HIV infection (anti-HIV1/2 antibody positive).
  • Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months).
  • HCV-GT 1 infection.
  • Age ≥18 years and ≤65 years.
  • No prior treatment with BOC/PEGIFN/RBV.
  • CD4+ cell count >200 cells/µL.
  • Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL.
  • Valid result on transient elastography or liver biopsy within 6 months prior to enrollment.
  • Female patients of childbearing potential must agree to use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
  • Male patients or their female partners must agree to use an effective contraceptive during treatment and for 7 months after treatment has been concluded.

Exclusion Criteria:

  • HCV-GT other than HCV-GT 1.
  • Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C).
  • Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis).
  • Significant cardiac disease (ejection fraction <40% at echocardiography).
  • Significant pulmonary disease (COPD stage GOLD III/IV).
  • Significant renal disease (serum creatinine >1.5 mg/dL).
  • Subjects taking medication(s) that is/are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as but not limited to, orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
  • Contraindications for boceprevir (Victrelis®, MSD), pegylated interferon alpha-2a (Pegasys®, Roche) or ribavirin (Copegus®, Roche), as listed in section 4.3 of the respective summary of product characteristics (SmPCs).
  • Ongoing alcohol abuse (average daily alcohol consumption >50g).
  • Ongoing illicit drug abuse.
  • Unwillingness to give written informed consent.
  • Pregnancy and breastfeeding.
  • Women wishing to become pregnant.

Sites / Locations

  • Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

28 weeks of treatment duration

48 weeks of treatment duration

Arm Description

All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.

All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks

Outcomes

Primary Outcome Measures

Proportion of Subjects With Sustained Virologic Response (SVR12)
Defined as HCV-RNA negativity by a sensitive assay
Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

Full Information

First Posted
August 15, 2013
Last Updated
February 8, 2017
Sponsor
Markus Peck-Radosavljevic
Collaborators
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01925183
Brief Title
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Acronym
HIVCOBOC-RGT
Official Title
Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFN/RBV in HIV/HCV-coinfected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Markus Peck-Radosavljevic
Collaborators
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used. The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic, HIV
Keywords
Boceprevir, HIV/HCV-coinfection, HIV/HCV coinfection, HIV/HCV, Response-guided therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
28 weeks of treatment duration
Arm Type
Experimental
Arm Description
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.
Arm Title
48 weeks of treatment duration
Arm Type
Experimental
Arm Description
All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alpha-2a
Other Intervention Name(s)
Pegasys®, Roche
Intervention Description
180mcg once weekly; subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®, Roche
Intervention Description
600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
Intervention Type
Drug
Intervention Name(s)
Boceprevir
Other Intervention Name(s)
Victrelis®, MSD
Intervention Description
800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
Primary Outcome Measure Information:
Title
Proportion of Subjects With Sustained Virologic Response (SVR12)
Description
Defined as HCV-RNA negativity by a sensitive assay
Time Frame
Follow-up week 12 (FU12)
Title
Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Baseline (BL) to Follow-up week 12 (FU12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed HIV infection (anti-HIV1/2 antibody positive). Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months). HCV-GT 1 infection. Age ≥18 years and ≤65 years. No prior treatment with BOC/PEGIFN/RBV. CD4+ cell count >200 cells/µL. Stable antiretroviral therapy (ART) including tenofovir/emtricitabine (Truvada®, Gilead) and raltegravir (Isentress®, MSD) with HIV-RNA <50 copies/mL. Valid result on transient elastography or liver biopsy within 6 months prior to enrollment. Female patients of childbearing potential must agree to use an effective contraceptive during treatment and for 4 months after treatment has been concluded. Male patients or their female partners must agree to use an effective contraceptive during treatment and for 7 months after treatment has been concluded. Exclusion Criteria: HCV-GT other than HCV-GT 1. Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa) with decompensated liver disease (Child-Pugh stage B/C). Chronic liver diseases other than hepatitis C virus infection (hepatitis B virus infection: HBsAg positivity, nonalcoholic steatohepatitis, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, cystic fibrosis). Significant cardiac disease (ejection fraction <40% at echocardiography). Significant pulmonary disease (COPD stage GOLD III/IV). Significant renal disease (serum creatinine >1.5 mg/dL). Subjects taking medication(s) that is/are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as but not limited to, orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine). Contraindications for boceprevir (Victrelis®, MSD), pegylated interferon alpha-2a (Pegasys®, Roche) or ribavirin (Copegus®, Roche), as listed in section 4.3 of the respective summary of product characteristics (SmPCs). Ongoing alcohol abuse (average daily alcohol consumption >50g). Ongoing illicit drug abuse. Unwillingness to give written informed consent. Pregnancy and breastfeeding. Women wishing to become pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Peck-Radosavljevic, MD
Organizational Affiliation
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C

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