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COMPLETED Phase 3

A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

NCT01479868 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.

Interventions

  • DRUG Ribavirin
  • DRUG TMC435
  • DRUG Pegylated interferon alpha-2a

Study Locations (20)

Other

  • — Lyon
  • — Montpellier
  • — Nantes
  • — Paris
  • — Berlin
  • — Bonn
  • — Cologne
  • — Düsseldorf

New York

  • — Albany
  • — New York

Texas

  • — Dallas
  • — Houston

California

  • — Los Angeles

District of Columbia

  • — Washington D.C.

Florida

  • — Orlando

Georgia

  • — Atlanta

Illinois

  • — Chicago

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2011-10
Est. Completion 2013-08
Phase Phase 3

Sponsor

Janssen R&D Ireland

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01479868

The ClinicalTrials.gov registry entry for NCT01479868 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen R&D Ireland, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hepatitis C Virus Genotype-1 appearing as the primary indexed condition, and to 3 interventions — of which Ribavirin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01479868 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01479868 about?

NCT01479868 is a clinical study titled "A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1". The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number ...

What is the current status of trial NCT01479868?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2011-10. Estimated completion is 2013-08.

What conditions does trial NCT01479868 study?

This clinical trial studies the following conditions: Hepatitis C Virus Genotype-1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01479868?

The interventions under investigation include: Ribavirin (DRUG), TMC435 (DRUG), Pegylated interferon alpha-2a (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01479868?

This trial is sponsored by Janssen R&D Ireland, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01479868 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial