Individualised triple therapy using boceprevir in combination with pegylated interferon and ribavirin in HIV-positive patients with hepatitis C

Response-guided triple therapy using boceprevir in combination with PEGIFN/RBV in HIV/HCV coinfected patients - HIVCOBOC-RGT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005591-33-AT

Enrollment

Unknown

Registered

2013-06-18

Start date

2013-07-29

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic genotype 1 HCV coinfection in HIV-positive patients. MedDRA version: 16.0 Level: LLT Classification code 10065949 Term: HCV coinfection System Organ Class: 10021881 - Infections and infestations MedDRA version: 16.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Victrelis Pharmaceutical Form: Capsule, hard INN or Proposed INN: Boceprevir Other descriptive name: BOCEPREVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Confirmed HIV infection (anti-HIV1/2 antibody positive) • Chronic HCV infection (anti-HCV positive, HCV-RNA detectable for >6 months) • HCV-genotype (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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • HCV-genotype other than HCV-GT1 • Ongoing alcohol abuse (average daily alcohol consumption >50g) • Ongoing illicit drug abuse • Significant cardiac disease (ejection fraction 1.5 mg/dL) • Cirrhotic patients (as defined by METAVIR F4 in liver biopsy or liver stiffness >12.3 kPa[1]) 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) • Unwillingness to give written informed consent • Pregancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary efficacy objective: • to assess the rate of sustained virologic response (SVR12) at follow-up week 12 (FU12), which is defined as HCV-RNA negativity by a sensitive PCR assay Primary safety/tolerability objective: • to assess the rate of adverse events (AEs) and severe adverse events (SAEs);Secondary Objective: Secondary efficacy objective: • to assess the rate of sustained virologic response (SVR24) at follow-up week 24 (FU24), which is defined as HCV-RNA negativity by a sensitive PCR assay Secondary safety/tolerability objectives: • to assess the incidence of hematologic AEs oAnemia • Grade I: Hb male <12/dL; female <11g/dL • Grade II: Hb <10g/dL • Grade III: Hb <8g/d • Grade IV: Hb <7g/dL o Thrombocytopenia • Grade I: Platelets <150 G/L • Grade II: Platelets <100 G/L • Grade III: Platelets <50 G/L • Grade IV: Platelets <20 G/L o Neutropenia • Grade I: ANC <1000/µL • Grade II: ANC <750/µL • Grade III: ANC <500/µL • Grade IV: ANC <200/µL • to assess the frequency and amount of erythropoietin analog (EPO) and granulocyte colony-stimulating factor analog (G-CSF) usage • to assess the rate of treatment discontinuation due to AEs • to assess the drop-out rate;Primary end point(s): Primary efficacy endpoint: • Rate of sustained virologic response (SVR12) at follow-up week 12 (FU12), which is defined as HCV-RNA negativity by a sensitive PCR assay Primary safety/tolerability endpoint: • Rate of adverse events (AEs) and severe adverse events (SAEs) ;Timepoint(s) of evaluation of this end point: See E.5.1	—

Measure

Time frame

Main Objective: Primary efficacy objective: • to assess the rate of sustained virologic response (SVR12) at follow-up week 12 (FU12), which is defined as HCV-RNA negativity by a sensitive PCR assay Primary safety/tolerability objective: • to assess the rate of adverse events (AEs) and severe adverse events (SAEs);Secondary Objective: Secondary efficacy objective: • to assess the rate of sustained virologic response (SVR24) at follow-up week 24 (FU24), which is defined as HCV-RNA negativity by a sensitive PCR assay Secondary safety/tolerability objectives: • to assess the incidence of hematologic AEs oAnemia • Grade I: Hb male <12/dL; female <11g/dL • Grade II: Hb <10g/dL • Grade III: Hb <8g/d • Grade IV: Hb <7g/dL o Thrombocytopenia • Grade I: Platelets <150 G/L • Grade II: Platelets <100 G/L • Grade III: Platelets <50 G/L • Grade IV: Platelets <20 G/L o Neutropenia • Grade I: ANC <1000/µL • Grade II: ANC <750/µL • Grade III: ANC <500/µL • Grade IV: ANC <200/µL • to assess the frequency and amount of erythropoietin analog (EPO) and granulocyte colony-stimulating factor analog (G-CSF) usage • to assess the rate of treatment discontinuation due to AEs • to assess the drop-out rate;Primary end point(s): Primary efficacy endpoint: • Rate of sustained virologic response (SVR12) at follow-up week 12 (FU12), which is defined as HCV-RNA negativity by a sensitive PCR assay Primary safety/tolerability endpoint: • Rate of adverse events (AEs) and severe adverse events (SAEs) ;Timepoint(s) of evaluation of this end point: See E.5.1

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoint: • Rate of sustained virologic response (SVR24) at follow-up week 24 (FU24), which is defined as HCV-RNA negativity by a sensitive PCR assay Secondary safety/tolerability endpoints: • Incidence of hematologic AEs;Timepoint(s) of evaluation of this end point: See E.5.2	—

Countries

Austria

Contacts

Public ContactVerantwortlicher Prüfer

Klin. Abt. f. Gastroenterologie u. Hepatologie, Universitätsklinik f. Innere Medizin III, Medizinische Universität Wien

markus.peck@meduniwien.ac.at+431404004744

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026