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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01467479
First received: November 3, 2011
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 160
Study Start Date: January 2012
Estimated Primary Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467479

  Show 59 Study Locations
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: October 19, 2012
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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors

ClinicalTrials.gov processed this record on March 03, 2013