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

March 3, 2015 updated by: Vertex Pharmaceuticals Incorporated

An Open Label,Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Edmonton
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton
      • Toronto, Ontario, Canada
        • Toronto
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal
  • Germany
      • Bonn, Germany
        • Bonn
      • Essen, Germany
        • Essen
      • Hamburg, Germany
        • Hamburg
      • Munchen, Germany
        • München
  • Puerto Rico
      • San Juan, Puerto Rico
        • Puerto Rico
  • Spain
      • Badalona, Spain
        • Spain
      • Barcelona, Spain
        • Barcelona
      • Madrid, Spain
        • Madrid
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Alabama
    • California
      • Bakersfield, California, United States
        • California
      • Beverly Hills, California, United States
        • California
      • Coronado, California, United States
        • California
      • Los Angeles, California, United States
        • California
      • Oakland, California, United States
        • California
      • Palo Alto, California, United States
        • California
      • Sacremento, California, United States
        • California
      • San Diego, California, United States
        • California
      • San Francisco, California, United States
        • California
    • Connecticut
      • New Haven, Connecticut, United States
        • Connecticut
    • District of Columbia
      • Washington, District of Columbia, United States
        • Washington, DC
      • Washington DC, District of Columbia, United States
        • DC
    • Florida
      • Bay Pines, Florida, United States
        • Florida
      • Jacksonville, Florida, United States
        • Florida
      • Miami, Florida, United States
        • Florida
      • Orlando, Florida, United States
        • Florida
      • West Palm Beach, Florida, United States
        • Florida
    • Georgia
      • Atlanta, Georgia, United States
        • Georgia
      • Decatur, Georgia, United States
        • Georgia
    • Illinois
      • Chicago, Illinois, United States
        • Illinois
    • Maine
      • Portland, Maine, United States
        • Maine
    • Maryland
      • Baltimore, Maryland, United States
        • Maryland
      • Lutherville, Maryland, United States
        • Maryland
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Massachusetts
    • Michigan
      • Detroit, Michigan, United States
        • Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Minnesota
    • Missouri
      • Kansas City, Missouri, United States
        • Missouri
      • Saint Louis, Missouri, United States
        • Missouri
    • New Jersey
      • Newark, New Jersey, United States
        • New Jersey
    • New Mexico
      • Santa Fe, New Mexico, United States
        • New Mexico
    • New York
      • Bronx, New York, United States
        • New York
      • New York, New York, United States
        • New York
      • Rochester, New York, United States
        • New York
    • North Carolina
      • Durham, North Carolina, United States
        • North Carolina
    • Ohio
      • Cincinnati, Ohio, United States
        • Ohio
      • Cleveland, Ohio, United States
        • Ohio
    • Oregon
      • Portland, Oregon, United States
        • Oregon
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States
        • Rhode Island
    • South Carolina
      • Columbia, South Carolina, United States
        • South Carlonia
    • Texas
      • Dallas, Texas, United States
        • Texas
      • Houston, Texas, United States
        • Texas
    • Utah
      • Salt Lake City, Utah, United States
        • UTAH
    • Virginia
      • Richmond, Virginia, United States
        • Virginia
    • Washington
      • Seattle, Washington, United States
        • Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (>) 1000 international units per milliliter (IU/mL)
  • Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse
  • Population B: Peg-IFN/RBV prior null or partial responder
  • Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration
  • Participant must have positive HIV antibody at Screening
  • Participant must have a diagnosis of HIV-1 infection >6 months before Screening

  • Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening:

    • Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine)
    • Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components
    • Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components
    • Boosted atazanavir plus Epzicom®, or equivalent components
    • Raltegravir plus Truvada®, or equivalent components
    • Raltegravir plus Epzicom®, or equivalent components
  • Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol
  • Laboratory values within acceptable ranges at Screening as specified in the protocol

Exclusion Criteria:

  • Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1
  • Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides
  • Contraindications to any planned HAART component as per the respective drug labeling information
  • Contraindications to Peg-IFN or RBV
  • Evidence of hepatic decompensation
  • Clinical suspicion of acute hepatitis
  • Any other cause of liver disease in addition to hepatitis C
  • History of organ transplantation (except cornea and skin)
  • Autoimmune-mediated disease
  • Participated in any investigational drug study within 90 days before Day 1
  • Previous treatment with an HCV protease inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: T/PR + HAART Regimen (ATV/r-Based)
Participants who were receiving atazanavir/ritonavir (ATV/r) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Drug: Ribavirin
Tablet
Other Names:
  • Copegus®
  • RBV
Drug: Telaprevir
Tablet
Other Names:
  • VX-950
Biological: Pegylated Interferon Alfa-2a
Subcutaneous Injection
Other Names:
  • Pegasys®
  • Peg-IFN-Alfa-2a
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.
Experimental: T/PR + HAART Regimen (EFV-Based)
Participants who were receiving efavirenz (EFV) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet three times a day for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Drug: Ribavirin
Tablet
Other Names:
  • Copegus®
  • RBV
Drug: Telaprevir
Tablet
Other Names:
  • VX-950
Biological: Pegylated Interferon Alfa-2a
Subcutaneous Injection
Other Names:
  • Pegasys®
  • Peg-IFN-Alfa-2a
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.
Experimental: T/PR + HAART Regimen (RAL-Based)
Participants who were receiving raltegravir (RAL) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
Drug: Ribavirin
Tablet
Other Names:
  • Copegus®
  • RBV
Drug: Telaprevir
Tablet
Other Names:
  • VX-950
Biological: Pegylated Interferon Alfa-2a
Subcutaneous Injection
Other Names:
  • Pegasys®
  • Peg-IFN-Alfa-2a
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
Time Frame: 12 weeks after last planned dose of study drug (up to Week 60)
SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
12 weeks after last planned dose of study drug (up to Week 60)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
Time Frame: 24 weeks after last planned dose of study drug (up to Week 72)
SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
24 weeks after last planned dose of study drug (up to Week 72)
Percentage of Participants With Rapid Viral Response (RVR)
Time Frame: Week 4
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.
Week 4
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Time Frame: Week 4 and Week 12
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
Week 4 and Week 12
Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)
Time Frame: EOT (up to Week 48)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.
EOT (up to Week 48)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 52
AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
Up to Week 52
Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
Time Frame: Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.
Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Time Frame: Baseline, follow-up (Week 96)
Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.
Baseline, follow-up (Week 96)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VX11-950-115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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