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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983853
• Other study ID #: VX08-950-110
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2009
• Last updated: August 2, 2013
• Start date: October 2009

Study information

• Verified date: August 2013
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infections

Intervention

Drug:
• 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

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated	Tibotec Pharmaceutical Limited

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Achieving Undetectable HCV RNA at Week 12		12 weeks after first dose of study drug	No
Secondary	Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12	number of subjects with undetectable HCV RNA	4 and 12 weeks after the first dose of study drug	No
Secondary	Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment		12 weeks after last dose of study drug	No
Secondary	Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure		through 12 weeks after first dose of study drug	No
Secondary	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)	through 12 weeks after first dose of study drug	No
Secondary	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)	through 12 weeks after first dose of study drug	No