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

This study has been terminated.
(It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.)
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01467479
First received: November 3, 2011
Last updated: March 3, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Telaprevir
Drug: Ribavirin
Biological: Pegylated Interferon Alfa-2a
Drug: Highly Active Antiretroviral Therapy (HAART)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Rapid Viral Response (RVR) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Extended Rapid Viral Response (eRVR) [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT) [ Time Frame: EOT (up to Week 48) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 185
Study Start Date: December 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Telaprevir
Tablet
Other Name: VX-950
Drug: Ribavirin
Tablet
Other Names:
  • Copegus®
  • RBV
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: Telaprevir
Tablet
Other Name: VX-950
Drug: Ribavirin
Tablet
Other Names:
  • Copegus®
  • RBV
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: Telaprevir
Tablet
Other Name: VX-950
Drug: Ribavirin
Tablet
Other Names:
  • Copegus®
  • RBV
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467479

  Hide Study Locations
Locations
United States, Alabama
Alabama
Birmingham, Alabama, United States
United States, California
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
United States, Connecticut
Connecticut
New Haven, Connecticut, United States
United States, District of Columbia
Washington, DC
Washington, District of Columbia, United States
DC
Washington DC, District of Columbia, United States
United States, Florida
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
United States, Georgia
Georgia
Atlanta, Georgia, United States
Georgia
Decatur, Georgia, United States
United States, Illinois
Illinois
Chicago, Illinois, United States
United States, Maine
Maine
Portland, Maine, United States
United States, Maryland
Maryland
Baltimore, Maryland, United States
Maryland
Lutherville, Maryland, United States
United States, Massachusetts
Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Michigan
Detroit, Michigan, United States
United States, Minnesota
Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
Missouri
Kansas City, Missouri, United States
Missouri
Saint Louis, Missouri, United States
United States, New Jersey
New Jersey
Newark, New Jersey, United States
United States, New Mexico
New Mexico
Santa Fe, New Mexico, United States
United States, New York
New York
Bronx, New York, United States
New York
New York, New York, United States
New York
Rochester, New York, United States
United States, North Carolina
North Carolina
Durham, North Carolina, United States
United States, Ohio
Ohio
Cincinnati, Ohio, United States
Ohio
Cleveland, Ohio, United States
United States, Oregon
Oregon
Portland, Oregon, United States
United States, Pennsylvania
Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Rhode Island
Rhode Island
Providence, Rhode Island, United States
United States, South Carolina
South Carlonia
Columbia, South Carolina, United States
United States, Texas
Texas
Dallas, Texas, United States
Texas
Houston, Texas, United States
United States, Utah
Utah
Salt Lake City, Utah, United States
United States, Virginia
Virginia
Richmond, Virginia, United States
United States, Washington
Washington
Seattle, Washington, United States
Canada, Alberta
Edmonton
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver
Vancouver, British Columbia, Canada
Canada, Ontario
Hamilton
Hamilton, Ontario, Canada
Toronto
Toronto, Ontario, Canada
Canada, Quebec
Montreal
Montreal, Quebec, Canada
Germany
Bonn
Bonn, Germany
Essen
Essen, Germany
Hamburg
Hamburg, Germany
Munchen
Munchen, Germany
Puerto Rico
Puerto Rico
San Juan, Puerto Rico
Spain
Spain
Badalona, Spain
Barcelona
Barcelona, Spain
Madrid
Madrid, Spain
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01467479     History of Changes
Other Study ID Numbers: VX11-950-115
Study First Received: November 3, 2011
Results First Received: March 3, 2015
Last Updated: March 3, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2015