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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
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: August 2, 2013
Last verified: August 2013
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:
- Proportion of Subjects Achieving Undetectable HCV RNA at Week 12 [ Time Frame: 12 weeks after first dose of study drug ]
Secondary Outcome Measures:
- Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12 [ Time Frame: 4 and 12 weeks after the first dose of study drug ]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 [ Time Frame: 12 weeks after last dose of study drug ]
- 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 ]
- Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART) [ Time Frame: through 12 weeks after first dose of study drug ]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) [ Time Frame: through 12 weeks after first dose of study drug ]Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)
| Enrollment: | 62 |
| 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 (Adult) |
| Sexes Eligible for Study: | All |
| 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
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: NCT00983853
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Results First Received: | August 2, 2013 |
| Last Updated: | August 2, 2013 |
Keywords provided by Vertex Pharmaceuticals Incorporated:
|
VX-950 INCIVEK INCIVO |
Additional relevant MeSH terms:
|
Infection Hepatitis Hepatitis A Hepatitis C HIV Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Lentivirus Infections |
Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ribavirin Peginterferon alfa-2a Interferon-alpha Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 19, 2017