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A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

NCT01467479 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2015-03-17

Study results available
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Summary

The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.

Conditions

  • Hepatitis C

Interventions

DRUG

Telaprevir

Tablet

DRUG

Ribavirin

Tablet

BIOLOGICAL

Pegylated Interferon Alfa-2a

Subcutaneous Injection

DRUG

Highly Active Antiretroviral Therapy (HAART)

Atazanavir/ritonavir (ATV/r) based HAART, Efavirenz (EFV) based HAART, or Raltegravir (RAL) based HAART, as per standard practice. HAART medications were not considered study drugs.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Canada
  • Germany
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01467479 on ClinicalTrials.gov