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

November 3, 2011
April 17, 2014
January 2012
February 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01467479 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
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 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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • 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 12 weeks

    eRVR+: undetectable HCV RNA at Weeks 4 and 12

    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Biological: peginterferon alfa-2a
  • 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

    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Biological: peginterferon alfa-2a
  • 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
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Biological: peginterferon alfa-2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Puerto Rico,   Spain
 
NCT01467479
VX11-950-115
Yes
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP