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

This study is currently recruiting participants.
Verified August 2013 by Medical University of Vienna
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Markus Peck-Radosavljevic, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01925183
First received: August 15, 2013
Last updated: August 16, 2013
Last verified: August 2013

August 15, 2013
August 16, 2013
August 2013
May 2015   (final data collection date for primary outcome measure)
  • Sustained virologic response (SVR12) [ Time Frame: Follow-up week 12 (FU12) ] [ Designated as safety issue: No ]
    Defined as HCV-RNA negativity by a sensitive assay
  • Adverse events (AEs) and severe adverse events (SAEs) [ Time Frame: Baseline (BL) to Follow-up week 12 (FU12) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01925183 on ClinicalTrials.gov Archive Site
  • Sustained virologic response (SVR24) [ Time Frame: Follow-up week 24 (FU24) ] [ Designated as safety issue: No ]
    Defined as HCV-RNA negativity by a sensitive assay
  • Anemia [ Time Frame: Baseline (BL) to follow-up at week 12 (FU12) ] [ Designated as safety issue: Yes ]
    Grade I: Hb male <12/dL, female <11g/dL; Grade II: Hb <10g/dL; Grade III: Hb <8g/dL; Grade IV: Hb <7g/dL
  • Thrombocytopenia [ Time Frame: Baseline (BL) to follow-up 12 (FU12) ] [ Designated as safety issue: Yes ]
    Grade I: Platelets <150 G/L; Grade II: Platelets <100 G/L; Grade III: Platelets <50 G/L; Grade IV: Platelets <20 G/L
  • Neutropenia [ Time Frame: Baseline (BL) to follow-up week 12 (FU12) ] [ Designated as safety issue: Yes ]
    Grade I: absolute neutrophil count (ANC) <1000/µL; Grade II: ANC <750/µL; Grade III: ANC <500/µL; Grade IV: ANC <200/µL
  • Erythropoietin (EPO) and granulocyte colony-stimulating factor (G-CSF) analogues use [ Time Frame: Baseline (BL) to follow-up week 12 (FU12) ] [ Designated as safety issue: Yes ]
  • Treatment discontinuation due to AEs [ Time Frame: Baseline (BL) to treatment week 28*/treatment week 48** ] [ Designated as safety issue: Yes ]

    * Patients with undetectable HCV-RNA levels at treatment week 8 (W8).

    ** Patients with detectable HCV-RNA levels at treatment week 8 (W8).

  • Drop-outs [ Time Frame: Baseline (BL) to follow-up week 12 (FU12) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Response-guided Triple-therapy Using Boceprevir in Combination With PEGIFN/RBV in HIV/HCV-coinfected Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C, Chronic
  • HIV
  • Drug: Pegylated interferon alpha-2a
    180mcg once weekly; subcutaneous injection
    Other Name: Pegasys®, Roche
  • Drug: Ribavirin
    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
    Other Name: Copegus®, Roche
  • Drug: Boceprevir
    800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
    Other Name: Victrelis®, MSD
  • Experimental: 28 weeks of treatment duration
    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.
    Interventions:
    • Drug: Pegylated interferon alpha-2a
    • Drug: Ribavirin
    • Drug: Boceprevir
  • Experimental: 48 weeks of treatment duration
    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
    Interventions:
    • Drug: Pegylated interferon alpha-2a
    • Drug: Ribavirin
    • Drug: Boceprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact: Mattias Mandorfer, MD +43 1 40400 ext 4744 mattias.mandorfer@meduniwien.ac.at
Austria
 
NCT01925183
HIVCOBOC-RGT, 2012-005591-33
Yes
Markus Peck-Radosavljevic, Medical University of Vienna
Markus Peck-Radosavljevic
Medical University of Vienna
Principal Investigator: Markus Peck-Radosavljevic, MD Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna
Medical University of Vienna
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP