An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic HCV-1 and HIV-1

Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects with Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection - INSIGHT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004928-35-SE

Enrollment

150

Registered

2011-12-20

Start date

2012-02-29

Completion date

Unknown

Last updated

2014-12-01

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

Conditions

Chronic hepatitis C infection MedDRA version: 16.0 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 100000004848

Interventions

Trade Name: INCIVO Product Name: INCIVO Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TELAPREVIR CAS Number: 402957-28-2 Other descriptive name: TELAPREVIR Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Chronic (detectable hepatitis C virus (HCV) ribonucleic acid (RNA) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level greater than 1,000 IU/mL - Confirmed diagnosis of Human immunodeficiency virus-1 (HIV-1) infection more than than 6 months before the screening visit - Cluster of differentiation 4 (CD4) count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit - HIV-1 RNA less than 50 copies/mL or patient must have HIV-1 RNA undetectable by a local specific HIV RNA test data at least once within 6 months of prior to the screening visit - No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit (or not greater than the lower limit of detection for assays with a limit of 500 copies/mL) - Currently taking one of the permitted anti- HIV regimens for greater than or equal to12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 146 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: - Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period through Week 14 - Infection or co-infection with HCV other than genotype 1 - Contraindication to the administration of Peg-IFN-alfa or RBV - Hepatitis B virus (HBV) co-infection - Acute or active condition of HIV-associated opportunistic infection within 6 months of screening

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the antiviral efficacy of telaprevir, Peg-IFN-alfa-2a, and RBV in HCV-1/HIV-1 coinfected subjects as measured by sustained virologic response (SVR12planned). SVR12planned is defined as having HCV RNA levels < 25 IU/mL 12 weeks after the last planned dose of HCV study medication.;Secondary Objective: Reference is made to section 2.1 (p.39 - 40) of the Clinical Trial Protocol.;Primary end point(s): Number of patients achieving sustained virologic response (SVR) 12 planned;Timepoint(s) of evaluation of this end point: Week 60	—

Measure

Time frame

Main Objective: The primary objective is to assess the antiviral efficacy of telaprevir, Peg-IFN-alfa-2a, and RBV in HCV-1/HIV-1 coinfected subjects as measured by sustained virologic response (SVR12planned). SVR12planned is defined as having HCV RNA levels < 25 IU/mL 12 weeks after the last planned dose of HCV study medication.;Secondary Objective: Reference is made to section 2.1 (p.39 - 40) of the Clinical Trial Protocol.;Primary end point(s): Number of patients achieving sustained virologic response (SVR) 12 planned;Timepoint(s) of evaluation of this end point: Week 60

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Secondary

Measure	Time frame
Secondary end point(s): - Number of patients achieving SVR12 defined as undetectable - Number of patients achieving SVR24 planned - Number of patients achieving SVR24 defined as undetectable - Number of patients achieving undetectable HCV RNA levels at Week 4 - Number of patients achieving undetectable HCV RNA levels at Week 12 - Number of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR) - Number of patients achieving undetectable HCV RNA at the actual end of treatment - Number of patients achieving undetectable HCV RNA at the planned end of treatment - Number of patients achieving HCV RNA less than 25 IU/mL at the planned end of treatment - Number of patients with ontreatment virologic failure - Number of patients with relapse during the follow-up period after previous undetectable HCV RNA at actual end of treatment - Number of patients with relapse during the follow-up period after previous undetectable HCV RNA at planned end of treatment - Number of patients with relapse during follow up period after previous HCV RNA less than 25 IU/mL at planned end of treatment - Number of patients with viral breakthrough - Change from baseline in log HCV RNA values - Number of patients with adverse events;Timepoint(s) of evaluation of this end point: - Week 60 - Week 72 - Week 72 - Week 4 - Week 12 - Week 4 and Week 12 - Week 24, Week 48, early discontinuation - Week 24, Week 48 - Week 24, Week 48 - Through Week 72 - Week 72 - Week 72 - Week 72 - Through Week 72 - Through Week 72 - Up to Week 72	—

Measure

Time frame

Secondary end point(s): - Number of patients achieving SVR12 defined as undetectable - Number of patients achieving SVR24 planned - Number of patients achieving SVR24 defined as undetectable - Number of patients achieving undetectable HCV RNA levels at Week 4 - Number of patients achieving undetectable HCV RNA levels at Week 12 - Number of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR) - Number of patients achieving undetectable HCV RNA at the actual end of treatment - Number of patients achieving undetectable HCV RNA at the planned end of treatment - Number of patients achieving HCV RNA less than 25 IU/mL at the planned end of treatment - Number of patients with ontreatment virologic failure - Number of patients with relapse during the follow-up period after previous undetectable HCV RNA at actual end of treatment - Number of patients with relapse during the follow-up period after previous undetectable HCV RNA at planned end of treatment - Number of patients with relapse during follow up period after previous HCV RNA less than 25 IU/mL at planned end of treatment - Number of patients with viral breakthrough - Change from baseline in log HCV RNA values - Number of patients with adverse events;Timepoint(s) of evaluation of this end point: - Week 60 - Week 72 - Week 72 - Week 4 - Week 12 - Week 4 and Week 12 - Week 24, Week 48, early discontinuation - Week 24, Week 48 - Week 24, Week 48 - Through Week 72 - Week 72 - Week 72 - Week 72 - Through Week 72 - Through Week 72 - Up to Week 72

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Countries

Australia, Brazil, France, Poland, Russian Federation, Spain, Sweden, United Kingdom

Contacts

Public ContactJanssen Biologics BV

Janssen-Cilag International NV - Clinical Registry Group

ClinicalTrialsEU@its.jnj.com+31071524 21 66

Outcome results

None listed

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