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
Results First Received: March 3, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: Telaprevir
Drug: Ribavirin
Biological: Pegylated Interferon Alfa-2a
Drug: Highly Active Antiretroviral Therapy (HAART)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study included Treatment-Naïve (no prior hepatitis C virus [HCV] therapy); Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin [Peg-IFN/RBV] and experienced viral relapse); and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Efficacy analyses were reported as per highly active antiretroviral therapy (HAART) treatment (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.

Reporting Groups
  Description
T/PR + HAART Regimen (ATV/r-Based) Participants who were receiving atazanavir/ritonavir (ATV/r) based 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.
T/PR + HAART Regimen (EFV-Based) Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 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.
T/PR + HAART Regimen (RAL-Based) Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 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.

Participant Flow:   Overall Study
    T/PR + HAART Regimen (ATV/r-Based)     T/PR + HAART Regimen (EFV-Based)     T/PR + HAART Regimen (RAL-Based)  
STARTED     55     69     61  
Treated     54     69     59  
COMPLETED     46     52     45  
NOT COMPLETED     9     17     16  
No Study Medication                 1                 0                 2  
Adverse Event                 1                 2                 0  
Death                 0                 0                 1  
Lost to Follow-up                 2                 5                 3  
Withdrawal of Consent                 3                 7                 7  
Study Terminated by Sponsor                 1                 3                 3  
Unspecified                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS), included all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
T/PR + HAART Regimen (ATV/r-Based) Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 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.
T/PR + HAART Regimen (EFV-Based) Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 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.
T/PR + HAART Regimen (RAL-Based) Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 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.
Total Total of all reporting groups

Baseline Measures
    T/PR + HAART Regimen (ATV/r-Based)     T/PR + HAART Regimen (EFV-Based)     T/PR + HAART Regimen (RAL-Based)     Total  
Number of Participants  
[units: participants]
  54     69     59     182  
Age  
[units: years]
Mean (Standard Deviation)
  50.4  (8.81)     49.6  (8.84)     48.4  (9.58)     49.5  (9.06)  
Gender  
[units: participants]
       
Female     6     9     15     30  
Male     48     60     44     152  



  Outcome Measures
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1.  Primary:   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) ]

2.  Secondary:   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) ]

3.  Secondary:   Percentage of Participants With Rapid Viral Response (RVR)   [ Time Frame: Week 4 ]

4.  Secondary:   Percentage of Participants With Extended Rapid Viral Response (eRVR)   [ Time Frame: Week 4 and Week 12 ]

5.  Secondary:   Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)   [ Time Frame: EOT (up to Week 48) ]

6.  Secondary:   Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to Week 52 ]

7.  Secondary:   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 ]

8.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
It was decided by Sponsor on 13 January 2014 to terminate the study early at the primary efficacy endpoint (SVR12) as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Monitor
Organization: Vertex Pharmaceuticals Incorporated
phone: 617-341-6777
e-mail: medicalinfo@vrtx.com


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