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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)

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telaprevir
Ribavirin
Pegylated-Interferon-alfa-2a
Sponsored by
Janssen-Cilag International NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV)

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
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
Change from baseline in log HCV RNA values at each time point during treatment.
Proportiond of patients achieving undetectable HCV RNA levels
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
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
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)
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
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
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
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
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
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.

Full Information

First Posted
January 16, 2012
Last Updated
May 4, 2016
Sponsor
Janssen-Cilag International NV
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1. Study Identification

Unique Protocol Identification Number
NCT01513941
Brief Title
An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)
Acronym
INSIGHT
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag International NV

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telaprevir plus Pegylated-Interferon-alfa-2a /ribavirin (RBV)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegylated-Interferon-alfa-2a
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
Description
Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in log HCV RNA values
Description
Change from baseline in log HCV RNA values at each time point during treatment.
Time Frame
Baseline and week 48
Title
Proportiond of patients achieving undetectable HCV RNA levels
Description
Proportion of patients achieving SVR24 planned, defined as having undetectable plasma HCV RNA levels 24 weeks after the last planned dose of study medication.
Time Frame
Up to 48 weeks
Title
Proportion of patients achieving undetectable HCV RNA levels at Week 4
Description
The proportion of patients who achieve rapid virologic response (RVR) and undetectable HCV RNA levels at Week 4 of treatment.
Time Frame
Up to 48 weeks
Title
Proportion of patients achieving undetectable HCV RNA levels at Week 12
Description
Proportion of patients achieving undetectable HCV RNA levels at Week 12 of treatment.
Time Frame
Up to 48 weeks
Title
Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)
Description
Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR).
Time Frame
Up to 48 weeks
Title
Proportion of patients achieving undetectable HCV RNA at the actual end of treatment
Description
Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).
Time Frame
Up to 48 weeks
Title
Proportion of patients achieving less than 25 IU/mL
Description
Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).
Time Frame
Up to 48 weeks
Title
Proportion of patients with on-treatment virologic failure
Description
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).
Time Frame
Up to 48 weeks
Title
Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels
Description
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.
Time Frame
Up to 48 weeks
Title
Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels
Description
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.
Time Frame
Up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag International NV, Belgium Clinical Trial
Organizational Affiliation
Janssen-Cilag International NV
Official's Role
Study Director
Facility Information:
City
Cairns
Country
Australia
City
Darlinghurst
Country
Australia
City
Melbourne
Country
Australia
City
Campinas
Country
Brazil
City
Rio De Janeiro
Country
Brazil
City
Santo André
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Le Kremlin Bicetre
Country
France
City
Marseille
Country
France
City
Nice N/A
Country
France
City
Paris Cedex 12
Country
France
City
Bydgoszcz
Country
Poland
City
Myslowice
Country
Poland
City
Warszawa
Country
Poland
City
Krasnodar
Country
Russian Federation
City
Perm
Country
Russian Federation
City
Saint-Petersburg
Country
Russian Federation
City
Smolensk
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Voronezh
Country
Russian Federation
City
Alicante
Country
Spain
City
Badalona
Country
Spain
City
Cordoba
Country
Spain
City
Elche
Country
Spain
City
Madrid
Country
Spain
City
San Sebastian
Country
Spain
City
Sevilla N/A
Country
Spain
City
Valencia
Country
Spain
City
Stockholm
Country
Sweden
City
Birmingham
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26483516
Citation
Montes ML, Nelson M, Girard PM, Sasadeusz J, Horban A, Grinsztejn B, Zakharova N, Rivero A, Durant J, Ortega-Gonzalez E, Lathouwers E, Janssen K, Ouwerkerk-Mahadevan S, Witek J, Gonzalez-Garcia J. Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study. J Antimicrob Chemother. 2016 Jan;71(1):244-50. doi: 10.1093/jac/dkv323. Epub 2015 Oct 19.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3446&filename=CR100778_CSR.pdf
Description
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 Immu(18137)

Learn more about this trial

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

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