Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
NCT ID: NCT00983853
Last Updated: 2013-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part A
The dose of ribavirin used (fixed versus weight-based) is region dependent
telaprevir or matching placebo
Tablet, Oral, 750 mg, q8h, 12 weeks
peginterferon alfa-2a
Subcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirin (fixed dose)
Tablet, Oral, 800 mg, b.i.d., 48 weeks
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
Part B
The dose of ribavirin used (fixed versus weight-based) is region dependent
telaprevir or matching placebo
Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks
peginterferon alfa-2a
Subcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirin (fixed dose)
Tablet, Oral, 800 mg, b.i.d., 48 weeks
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
Interventions
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telaprevir or matching placebo
Tablet, Oral, 750 mg, q8h, 12 weeks
telaprevir or matching placebo
Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks
peginterferon alfa-2a
Subcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirin (fixed dose)
Tablet, Oral, 800 mg, b.i.d., 48 weeks
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 Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Tibotec Pharmaceutical Limited
INDUSTRY
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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Beverly Hills, California, United States
San Diego, California, United States
San Francisco, California, United States
Miami, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
New York, New York, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
Paris, , France
Bonn-Venusberg, , Germany
Hamburg, , Germany
Barcelona, , Spain
Madrid, , Spain
Countries
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References
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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.
Other Identifiers
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VX08-950-110
Identifier Type: -
Identifier Source: org_study_id