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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01467479
First received: November 3, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to treat HIV and HCV coinfected subjects with telaprevir, peg-interferon alfa-2a, and ribavirin to achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug.


Condition Intervention Phase
Hepatitis C
Drug: Telaprevir
Drug: Ribavirin
Biological: peginterferon alfa-2a
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:
  • Proportion of subjects who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug (sustained viral response [SVR12]) [ Time Frame: 12 weeks after the last planned dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) [ Time Frame: 24 weeks after the last planned dose of study drug ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve undetectable HCV RNA at Week 4 (rapid viral response [RVR]), Week 4 and Week 12 (extended rapid viral response [eRVR]), and planned End of Treatment (EOT) [ Time Frame: up to 48 Weeks ] [ Designated as safety issue: No ]
  • Safety as assessed by AEs, clinical laboratory results, HIV RNA assessments, CD4 counts, 12 lead electrocardiograms (ECGs), and vital signs [ Time Frame: up to 52 Weeks ] [ Designated as safety issue: Yes ]
  • PK of telaprevir, Peg IFN, RBV, and pre-defined HAART medications [ Time Frame: up to 52 Weeks ] [ Designated as safety issue: No ]
  • Amino acid sequence of the HCV NS3•4A protease region [ Time Frame: up to 96 Weeks ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relapsers and Naives (eRVR+)

Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks followed by Peg-IFN-alfa-2a + RBV for 12 weeks

eRVR+: undetectable HCV RNA at Weeks 4 and 12

Drug: Telaprevir
1125 mg bid or 1125 mg tid (with efavirenz based regimens)for 12 weeks.
Drug: Ribavirin
800 mg/day for 24 or 48 weeks.
Biological: peginterferon alfa-2a
180 mcg/week for 24 or 48 weeks
Experimental: Relapsers and Naives (eRVR-)

Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks

eRVR-: detectable HCV RNA at Week 4 or Week 12

Drug: Telaprevir
1125 mg bid or 1125 mg tid (with efavirenz based regimens)for 12 weeks.
Drug: Ribavirin
800 mg/day for 24 or 48 weeks.
Biological: peginterferon alfa-2a
180 mcg/week for 24 or 48 weeks
Experimental: Null/Partial
All Null/Partial subjects receive Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks
Drug: Telaprevir
1125 mg bid or 1125 mg tid (with efavirenz based regimens)for 12 weeks.
Drug: Ribavirin
800 mg/day for 24 or 48 weeks.
Biological: peginterferon alfa-2a
180 mcg/week for 24 or 48 weeks

  Eligibility

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

Inclusion Criteria:

  • Subjects must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA >1000 IU/mL
  • Population A: HCV Peg IFN/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse
  • Population B: Peg-INF/RBV prior null or partial responder
  • Subjects must not have achieved SVR24 after at least 1 prior course of Peg IFN/RBV therapy of standard duration
  • Subject must have positive HIV antibody at Screening
  • Subject must have a diagnosis of HIV-1 infection >6 months before Screening
  • Subjects should be taking 1 of the following permissible 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
  • CD4 counts and HIV-1 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
Last Updated: April 17, 2014
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors

ClinicalTrials.gov processed this record on August 21, 2014