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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01513941
First received: January 16, 2012
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Chronic Hepatitis C
Drug: Telaprevir
Drug: Ribavirin
Drug: Pegylated-Interferon-alfa-2a
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.


Secondary Outcome Measures:
  • Change from baseline in log HCV RNA values [ Time Frame: Baseline and week 48 ] [ Designated as safety issue: No ]
    Change from baseline in log HCV RNA values at each time point during treatment.

  • Proportiond of patients achieving undetectable HCV RNA levels [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients achieving SVR24 planned, defined as having undetectable plasma HCV RNA levels 24 weeks after the last planned dose of study medication.

  • Proportion of patients achieving undetectable HCV RNA levels at Week 4 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    The proportion of patients who achieve rapid virologic response (RVR) and undetectable HCV RNA levels at Week 4 of treatment.

  • Proportion of patients achieving undetectable HCV RNA levels at Week 12 [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients achieving undetectable HCV RNA levels at Week 12 of treatment.

  • Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR).

  • Proportion of patients achieving undetectable HCV RNA at the actual end of treatment [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).

  • Proportion of patients achieving less than 25 IU/mL [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).

  • Proportion of patients with on-treatment virologic failure [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    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).

  • Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    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.

  • Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 163
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513941

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
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Study Director: Janssen-Cilag International NV, Belgium Clinical Trial Janssen-Cilag International NV
  More Information

No publications provided

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01513941     History of Changes
Other Study ID Numbers: CR100778, VX-950HPC3008, 2011-004928-35
Study First Received: January 16, 2012
Last Updated: July 9, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Spain: Ministry of Health and Consumption
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
Great Britain: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Janssen-Cilag International NV:
Chronic hepatitis C
Genotype 1 chronic hepatitis C
Treatment experienced with HCV-1/HIV-1 coinfection
Telaprevir
Pegylated-Interferon-alfa-2a
Ribavirin
HCV-1/HIV-1 coinfection
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Immunologic Deficiency Syndromes
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents

ClinicalTrials.gov processed this record on October 02, 2014