An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1) (INSIGHT)

May 4, 2016 updated by: Janssen-Cilag International NV

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

The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Cairns, Australia
      • Darlinghurst, Australia
      • Melbourne, Australia
  • Brazil
      • Campinas, Brazil
      • Rio De Janeiro, Brazil
      • Santo André, Brazil
      • Sao Paulo, Brazil
  • France
      • Le Kremlin Bicetre, France
      • Marseille, France
      • Nice N/A, France
      • Paris Cedex 12, France
  • Poland
      • Bydgoszcz, Poland
      • Myslowice, Poland
      • Warszawa, Poland
  • Russian Federation
      • Krasnodar, Russian Federation
      • Perm, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Smolensk, Russian Federation
      • St Petersburg, Russian Federation
      • Voronezh, Russian Federation
  • Spain
      • Alicante, Spain
      • Badalona, Spain
      • Cordoba, Spain
      • Elche, Spain
      • Madrid, Spain
      • San Sebastian, Spain
      • Sevilla N/A, Spain
      • Valencia, Spain
  • Sweden
      • Stockholm, Sweden
  • United Kingdom
      • Birmingham, United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic (detectable 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 HIV-1 infection greater than 6 months before the screening visit
  • 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 undetectable by an ultrasensitive assay at least once within 90 days of the screening visit
  • No HIV RNA values greater than 200 copies/mL within 6 months of the screening visit
  • Currently taking one of the permitted anti-HIV regimens for greater than or equal to12 weeks

Exclusion Criteria:

  • Anticipated need to switch anti-HIV regimen from screening through the Telaprevir treatment period
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV)
All patients who will receive 12 weeks of treatment with telaprevir 750 mg q8h except for patients on efavirenz will receive 1125 mg every 8 hours (q8h) in combination with Pegylated-Interferon-alfa-2a (Peg-IFN-alfa-2a) 180 μg/week and RBV 800 mg/day. At Week 12, telaprevir dosing will end and the patients will continue on Peg-IFN-alfa-2a and RBV.
Drug: Telaprevir
Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.
Drug: Ribavirin
Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.
Drug: Pegylated-Interferon-alfa-2a
Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
Time Frame: Up to 48 weeks
Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.
Up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in log HCV RNA values
Time Frame: Baseline and week 48
Change from baseline in log HCV RNA values at each time point during treatment.
Baseline and week 48
Proportiond of patients achieving undetectable HCV RNA levels
Time Frame: Up to 48 weeks
Proportion of patients achieving SVR24 planned, defined as having undetectable plasma HCV RNA levels 24 weeks after the last planned dose of study medication.
Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA levels at Week 4
Time Frame: Up to 48 weeks
The proportion of patients who achieve rapid virologic response (RVR) and undetectable HCV RNA levels at Week 4 of treatment.
Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA levels at Week 12
Time Frame: Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA levels at Week 12 of treatment.
Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)
Time Frame: Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR).
Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA at the actual end of treatment
Time Frame: Up to 48 weeks
Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).
Up to 48 weeks
Proportion of patients achieving less than 25 IU/mL
Time Frame: Up to 48 weeks
Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).
Up to 48 weeks
Proportion of patients with on-treatment virologic failure
Time Frame: Up to 48 weeks
Proportion of patients with on-treatment virologic failure (an increase greater than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA greater than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).
Up to 48 weeks
Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels
Time Frame: Up to 48 weeks
Proportion of patients who relapse (having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA levels (less than 25 IU/mL, undetectable) at planned end of treatment.
Up to 48 weeks
Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels
Time Frame: Up to 48 weeks
Proportion of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag International NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100778
  • VX-950HPC3008 (Other Identifier: Janssen-Cilag International NV, Belgium)
  • 2011-004928-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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