Telaprevir Open-Label Study in Co-Infected Patients

August 16, 2016 updated by: Janssen-Cilag International NV

Multicenter, Open-Label, Study of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Human Immunodeficiency Virus/Genotype 1 Chronic Hepatitis C Coinfected Subjects With Severe Fibrosis or Compensated Cirrhosis

The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV in patients with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment into an ongoing clinical study of telaprevir.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, all patients will receive open-label (all people involved know the identity of the intervention) telaprevir in addition to Peg IFN-alfa and RBV for treatment of hepatitis C virus (HCV) and protocol permissible treatments for HIV. Chronic hepatitis C infection causes inflammation of the liver which can potentially cause long-term complications of the current liver disease (fibrosis or cirrhosis). Therefore it is important the patient is treated for this infection. Telaprevir is an experimental medication that has been tested for the treatment of hepatitis C infections in several previous studies in more than 2500 patients. Telaprevir is a member of a new class of drugs being developed for chronic hepatitis C: Direct Acting Antiviral (DAA) agents. Unlike pegylated interferon (Peg-IFN) and ribavirin (RBV), DAA agents act directly on the hepatitis C virus (HCV) replication cycle. The aim of the telaprevir treatment is to eradicate the Hepatitis C virus out of the patient's body. This can be measured by testing the amount of a certain part of this Hepatitis C virus, called the Ribonucleic acid (RNA [HCV RNA]) in their blood. It is possible that the patient will not respond to the therapy and the levels of HCV RNA in their blood will not decrease or even increase. Based on these results it might be decided the patient will not benefit from treatment and he/she need to stop the telaprevir only or all medication for their hepatitis C infection. The doctor will keep them informed about the patient's reaction to the treatment and will take the necessary measurements as prescribed by the study protocol and routine medical practice. During the study the patient will simultaneously be treated with the therapy that the doctor would normally prescribe for treatment of their chronic hepatitis C infection: "ribavirin (RBV)" and "pegylated interferon alfa (PEG-INF-alfa)". Telaprevir is always administered in combination with RBV and PEG-IFN-alfa. In function of the patient's specific HIV status, the doctor has prescribed, or not, a specific treatment that the patient will continue to take during the study. This treatment could be: (a) efavirenz, tenofovir disoproxil fumarate (TDF), plus either emtricitabine or lamivudine, (b) efavirenz, abacavir, plus either emtricitabine or lamivudine, (c) ritonavir-boosted atazanavir, TDF, plus either emtricitabine or lamivudine, (d) ritonavir-boosted atazanavir, abacavir, plus either emtricitabine or lamivudine, (e) raltegravir, TDF, plus either emtricitabine or lamivudine, (f) raltegravir, abacavir, plus either emtricitabine or lamivudine or (g) etravirine, TDF, plus either emtricitabine or lamivudin, (h) etravirine, abacavir, plus either emtricitabine or lamivudine, (i) rilpivirine, TDF, plus either emtricitabine or lamivudine, (j) rilpivirine, abacavir, plus either emtricitabine or lamivudine, (k) no treatment. In an interim analysis of a Phase 2a study, human immunodeficiency virus (HIV)-1/HCV genotype 1 coinfected patients currently receiving HIV therapy who had telaprevir added to Peg IFN-alfa-2a and RBV regimen for treatment of their HCV genotype 1 infection had a higher HCV RNA response (undetectable HCV RNA) at Weeks 4 and 12 than those who received only the Peg-IFN-alfa-2a and RBV regimen. These responses were sustained through Week 24, with 73.7% of patients who had telaprevir added to the Peg-IFN-alfa-2a and RBV regimen and 54.5% of patients who received only the Peg-IFN-alfa-2a and RBV regimen also achieving undetectable HCV RNA at Week 24. Patients with severe fibrosis or cirrhosis have a lower likelihood of sustained virologic response (SVR) and also have the greatest risk of liver failure, hepatocellular carcinoma (HCC), and death. Administering telaprevir in this difficult to treat population may reduce the risk of long-term complications associated with HCV in patients with HIV/HCV genotype 1 coinfection. All patients eligible to enter the study will receive telaprevir (750 or 1,125 mg every 8 hours based on their Highly Active Antiretroviral Therapy (HAART) regimen) during the first 12 weeks of the study in combination with Peg IFN alfa/RBV. Patients will subsequently be treated with Peg-IFN-alfa/RBV for an additional 36 weeks. The total duration of Peg-IFN-alfa/RBV will be 48 weeks. HCV RNA levels should be measured at Weeks 4, 12, 24 and 48. All patients should have a posttreatment follow-up visit, including measurement of plasma HCV RNA levels, performed 24 weeks after the last administered dose of treatment. Note that in certain countries, an additional main objective of the study is to provide Early Access to telaprevir in this population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Antwerpen, Belgium
      • Brussel, Belgium
      • Bruxelles, Belgium
      • Charleroi, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Liège, Belgium
  • Germany
      • Berlin, Germany
      • Bonn, Germany
      • Dortmund, Germany
      • Frankfurt, Germany
      • Hannover, Germany
      • Köln, Germany
      • Stuttgart, Germany
      • Tübingen, Germany
  • Hungary
      • Budapest, Hungary
  • Ireland
      • Dublin, Ireland
  • Luxembourg
      • Luxembourg, Luxembourg
  • Portugal
      • Amadora, Portugal
      • Lisboa, Portugal
      • Lisbon, Portugal
      • Porto, Portugal
  • Russian Federation
      • Perm, Russian Federation
      • Saint-Petersburg, Russian Federation
      • St Petersburg, Russian Federation
      • Toliatti, Russian Federation
      • Volgograd, Russian Federation
      • Yoshkar - Ola, Russian Federation
  • United Kingdom
      • Glasgow, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Plymouth, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Have diagnosis of HIV-1 or HIV-2 infection, or HIV-1 and HIV-2 coinfection for more than 6 months before the screening visit. - Should have been on a stable permissible HAART regimen for more than 8 weeks before Day 1 without switches. OR Not on a HAART regimen and not expected to start HIV treatment during the study, ie, have CD4 count of ≥500 cells/mm3 and a HIV-1 and/or HIV-2 viral load ≤50,000 copies/mL at screening - If on stable permissible HAART regimen, have CD4 count ≥200 cells/mm3 or ≥15% and HIV-1 and/or HIV-2 viral load <50 copies/mL for at least 6 months before starting treatment is recommended - Have evidence of HCV infection genotype 1 (molecular assay) - Have a quantifiable plasma HCV RNA Exclusion Criteria: - Is eligible for enrollment into an ongoing clinical study of telaprevir - Is infected or coinfected with HCV of another genotype than genotype 1 - Has a contraindication to the administration of Peg-IFN-alfa or RBV, or medical history or laboratory values that preclude treatment with Peg-IFN-alfa or RBV according to the respective local prescribing information - Have any contraindication to the currently prescribed HAART regimen at screening. Note: Patients who have a contraindication to a nonprescribed permissible HAART medication are not excluded. - Positive human leukocyte antigen (HLA)-B5701 genotyping result at screening (or documented result prior to screening) if abacavir is a component of HAART

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: open label telaprevir
Depending on the patient's HAART regimen, 750 or 1125 mg telaprevir every 8 hours for 12 weeks in combination with pegylated interferon alfa and ribavirin for 48 weeks.
Drug: Telaprevir
type = exact number, unit = mg, number = 750, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with pegylated interferon alfa (Peg-IFN alfa) and ribavirin (RBV) during 48 weeks for eligible non treated HIV patients and for patients whose highly active antiretroviral therapy (HAART) regimen is the combination of ritonavir-boosted atazanavir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or the combination of raltegravir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.
Drug: Telaprevir
type = exact number, unit = mg, number = 1125, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with Peg-IFN alfa and RBV during 48 weeks when patient's HAART regimen is the combination of efavirenz, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment-emergent Adverse Events
Time Frame: from first use of the medicinal product to 30 days after administration of the last dose of investigational product (telaprevir)
Protocol-defined adverse events whether serious or non-serious, that occur from the first use of investigational product (telaprevir) to 30 days after administration of the last dose of investigational product (telaprevir) will be part of the analysis.
from first use of the medicinal product to 30 days after administration of the last dose of investigational product (telaprevir)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR018787
  • VX-950HPC3005 (Other Identifier: Janssen-Cilag International NV)
  • 2011-003593-85 (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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