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Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV

Primary Purpose

Hepatitis C, HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
telaprevir or matching placebo
telaprevir or matching placebo
peginterferon alfa-2a
ribavirin (fixed dose)
ribavirin (weight-based dose)
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring VX-950, INCIVEK, INCIVO

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic, genotype 1, hepatitis C with detectable HCV RNA
  • HIV-1 infection for >6 months
  • Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis)

Exclusion Criteria:

  • Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
  • Previous treatment with interferon or ribavirin
  • Evidence of hepatic decompensation in cirrhotic subjects
  • Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
  • Part A only: subjects who have been on a HAART regimen within 12 weeks before study start

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A

Part B

Arm Description

The dose of ribavirin used (fixed versus weight-based) is region dependent

The dose of ribavirin used (fixed versus weight-based) is region dependent

Outcomes

Primary Outcome Measures

Proportion of Subjects Achieving Undetectable HCV RNA at Week 12

Secondary Outcome Measures

Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
number of subjects with undetectable HCV RNA
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)
Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)
Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)
Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)

Full Information

First Posted
September 22, 2009
Last Updated
August 2, 2013
Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
Tibotec Pharmaceutical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00983853
Brief Title
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
Official Title
A Phase 2a, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Who Have Chronic HCV-1/HIV-1 Co-Infection and Are Treatment-Naïve for Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
Tibotec Pharmaceutical Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, HIV Infections
Keywords
VX-950, INCIVEK, INCIVO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A
Arm Type
Experimental
Arm Description
The dose of ribavirin used (fixed versus weight-based) is region dependent
Arm Title
Part B
Arm Type
Experimental
Arm Description
The dose of ribavirin used (fixed versus weight-based) is region dependent
Intervention Type
Drug
Intervention Name(s)
telaprevir or matching placebo
Intervention Description
Tablet, Oral, 750 mg, q8h, 12 weeks
Intervention Type
Drug
Intervention Name(s)
telaprevir or matching placebo
Intervention Description
Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks
Intervention Type
Biological
Intervention Name(s)
peginterferon alfa-2a
Intervention Description
Subcutaneous injection, 180 μg, once weekly, 48 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin (fixed dose)
Intervention Description
Tablet, Oral, 800 mg, b.i.d., 48 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin (weight-based dose)
Intervention Description
Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
Primary Outcome Measure Information:
Title
Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
Time Frame
12 weeks after first dose of study drug
Secondary Outcome Measure Information:
Title
Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
Description
number of subjects with undetectable HCV RNA
Time Frame
4 and 12 weeks after the first dose of study drug
Title
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
Time Frame
12 weeks after last dose of study drug
Title
Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
Time Frame
through 12 weeks after first dose of study drug
Title
Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)
Description
Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)
Time Frame
through 12 weeks after first dose of study drug
Title
Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)
Description
Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)
Time Frame
through 12 weeks after first dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic, genotype 1, hepatitis C with detectable HCV RNA HIV-1 infection for >6 months Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis) Exclusion Criteria: Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C Previous treatment with interferon or ribavirin Evidence of hepatic decompensation in cirrhotic subjects Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months Part A only: subjects who have been on a HAART regimen within 12 weeks before study start
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
City
Paris
Country
France
City
Bonn-Venusberg
Country
Germany
City
Hamburg
Country
Germany
City
Barcelona
Country
Spain
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23685940
Citation
Sulkowski MS, Sherman KE, Dieterich DT, Bsharat M, Mahnke L, Rockstroh JK, Gharakhanian S, McCallister S, Henshaw J, Girard PM, Adiwijaya B, Garg V, Rubin RA, Adda N, Soriano V. Combination therapy with telaprevir for chronic hepatitis C virus genotype 1 infection in patients with HIV: a randomized trial. Ann Intern Med. 2013 Jul 16;159(2):86-96. doi: 10.7326/0003-4819-159-2-201307160-00654.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV

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