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

November 3, 2011
March 3, 2015
December 2011
February 2014   (final data collection date for primary outcome measure)
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).
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 ]
Complete list of historical versions of study NCT01467479 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
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 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.

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
    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 (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.
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Biological: Pegylated Interferon Alfa-2a
    • Drug: Highly Active Antiretroviral Therapy (HAART)
  • 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.
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Biological: Pegylated Interferon Alfa-2a
    • Drug: Highly Active Antiretroviral Therapy (HAART)
  • 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.
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Biological: Pegylated Interferon Alfa-2a
    • Drug: Highly Active Antiretroviral Therapy (HAART)
Not Provided

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

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
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
Mexico
 
NCT01467479
VX11-950-115
Yes
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
March 2015

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