Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
This study has been completed.
Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00983853
First received: September 22, 2009
Last updated: December 18, 2012
Last verified: March 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C HIV Infections |
Drug: telaprevir or matching placebo Biological: peginterferon alfa-2a Drug: ribavirin (fixed dose) Drug: ribavirin (weight-based dose) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Vertex Pharmaceuticals Incorporated:
Primary Outcome Measures:
- Safety (adverse events, physical examination findings, clinical laboratory results, and vital sign assessments) [ Time Frame: through 4 weeks after last dose of study drug ] [ Designated as safety issue: Yes ]
- Plasma HCV RNA level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HCV viral kinetics [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Plasma concentrations of study drugs (Cmax, AUC, and tmax) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Undetectable HCV RNA [ Time Frame: 4 weeks, 12 weeks, end of treatment, 12 weeks after last dose, 24 weeks after last dose ] [ Designated as safety issue: No ]
- Amino acid sequence of the HCV NS3•4A protease [ Time Frame: through 24 weeks after last dose of study drug ] [ Designated as safety issue: No ]
- Plasma concentrations of highly active antiretroviral therapy (HAART) medications (Part B only) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 68 |
| Study Start Date: | October 2009 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Part A
The dose of ribavirin used (fixed versus weight-based) is region dependent
|
Drug: telaprevir or matching placebo
Tablet, Oral, 750 mg, q8h, 12 weeks
Biological: peginterferon alfa-2a
Subcutaneous injection, 180 μg, once weekly, 48 weeks
Drug: ribavirin (fixed dose)
Tablet, Oral, 800 mg, b.i.d., 48 weeks
Drug: ribavirin (weight-based dose)
Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
|
|
Experimental: Part B
The dose of ribavirin used (fixed versus weight-based) is region dependent
|
Drug: telaprevir or matching placebo
Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks
Biological: peginterferon alfa-2a
Subcutaneous injection, 180 μg, once weekly, 48 weeks
Drug: ribavirin (fixed dose)
Tablet, Oral, 800 mg, b.i.d., 48 weeks
Drug: ribavirin (weight-based dose)
Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00983853
Locations
| United States, California | |
| Beverly Hills, California, United States, 90211 | |
| San Diego, California, United States, 92093 | |
| San Francisco, California, United States, 94110 | |
| United States, Florida | |
| Miami, Florida, United States, 33125 | |
| Orlando, Florida, United States, 32803 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New York | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Texas | |
| Dallas, Texas, United States, 75204 | |
| France | |
| Paris, France | |
| Germany | |
| Bonn-Venusberg, Germany | |
| Hamburg, Germany | |
| Spain | |
| Barcelona, Spain | |
| Madrid, Spain | |
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited
Investigators
| Study Director: | Medical Monitor | Vertex Pharmaceuticals Incorporated |
More Information
No publications provided
| Responsible Party: | Vertex Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT00983853 History of Changes |
| Other Study ID Numbers: | VX08-950-110 |
| Study First Received: | September 22, 2009 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Vertex Pharmaceuticals Incorporated:
|
VX-950 INCIVEK INCIVO |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013