Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00983853
First received: September 22, 2009
Last updated: August 2, 2013
Last verified: August 2013
Results First Received: August 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hepatitis C
HIV Infections
Interventions: Drug: telaprevir or matching placebo
Biological: peginterferon alfa-2a
Drug: ribavirin (fixed dose)
Drug: ribavirin (weight-based dose)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Part A: T/PR

Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks

Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks

Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks

Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

The dose of ribavirin used (fixed versus weight-based) was region dependent.

Part A: Pbo/PR

Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks

Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks

Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks

Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

The dose of ribavirin used (fixed versus weight-based) was region dependent.

Part B: EFV-based HAART + T/PR

Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine

Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks

Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks

Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks

Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

The dose of ribavirin used (fixed versus weight-based) was region dependent.

Part B: EFV-based HAART + Pbo/PR

Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine

Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks

Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks

Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks

Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

The dose of ribavirin used (fixed versus weight-based) was region dependent.

Part B: ATV/R-based HAART + T/PR

Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine

Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks

Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks

Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks

Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

The dose of ribavirin used (fixed versus weight-based) was region dependent.

Part B: ATV/R-based HAART + Pbo/PR

Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine

Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks

Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks

Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks

Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks

The dose of ribavirin used (fixed versus weight-based) was region dependent.


Participant Flow:   Overall Study
    Part A: T/PR     Part A: Pbo/PR     Part B: EFV-based HAART + T/PR     Part B: EFV-based HAART + Pbo/PR     Part B: ATV/R-based HAART + T/PR     Part B: ATV/R-based HAART + Pbo/PR  
STARTED     7     7 [1]   17 [1]   8     15     8  
COMPLETED     6     5     14     6     12     7  
NOT COMPLETED     1     2     3     2     3     1  
Lost to Follow-up                 1                 1                 2                 2                 2                 1  
Withdrawal by Subject                 0                 0                 1                 0                 1                 0  
Unable to come to study follow-up visits                 0                 1                 0                 0                 0                 0  
[1] 1 subject was randomized but not dosed



  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.
All randomized subjects who received at least 1 dose of study drug

Reporting Groups
  Description
Part A: T/PR Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
Part A: Pbo/PR Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
Part B: EFV-based HAART + T/PR Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
Part B: EFV-based HAART + Pbo/PR Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
Part B: ATV/R-based HAART + T/PR Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
Part B: ATV/R-based HAART + Pbo/PR Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
Total Total of all reporting groups

Baseline Measures
    Part A: T/PR     Part A: Pbo/PR     Part B: EFV-based HAART + T/PR     Part B: EFV-based HAART + Pbo/PR     Part B: ATV/R-based HAART + T/PR     Part B: ATV/R-based HAART + Pbo/PR     Total  
Number of Participants  
[units: participants]
  7     6     16     8     15     8     60  
Age  
[units: years]
Median ( Full Range )
             
median (min, max)     39.4  
  ( 34 to 50 )  
  47.5  
  ( 42 to 65 )  
  47.5  
  ( 31 to 57 )  
  47.0  
  ( 31 to 53 )  
  52.0  
  ( 36 to 59 )  
  39.0  
  ( 26 to 53 )  
  44.5  
  ( 26 to 65 )  
Gender  
[units: participants]
             
Female     1     2     0     1     2     1     7  
Male     6     4     16     7     13     7     53  
Ethnicity (NIH/OMB)  
[units: participants]
             
Hispanic or Latino     3     2     5     1     3     3     17  
Not Hispanic or Latino     4     4     10     7     12     5     42  
Unknown or Not Reported     0     0     1     0     0     0     1  
Race/Ethnicity, Customized  
[units: participants]
             
White     2     3     12     5     13     7     42  
Black/African American     4     3     3     3     2     1     16  
American Indian/Alaska Native     1     0     0     0     0     0     1  
Other     0     0     1     0     0     0     1  
Region of Enrollment  
[units: participants]
             
North America     7     5     13     8     9     4     46  
United States     7     5     13     8     9     4     46  
Europe     0     1     3     0     6     4     14  
Germany     0     0     1     0     1     1     3  
Spain     0     1     2     0     3     3     9  
France     0     0     0     0     2     0     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Subjects Achieving Undetectable HCV RNA at Week 12   [ Time Frame: 12 weeks after first dose of study drug ]

2.  Secondary:   Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12   [ Time Frame: 4 and 12 weeks after the first dose of study drug ]

3.  Secondary:   Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment   [ Time Frame: 12 weeks after last dose of study drug ]

4.  Secondary:   Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure   [ Time Frame: through 12 weeks after first dose of study drug ]

5.  Secondary:   Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)   [ Time Frame: through 12 weeks after first dose of study drug ]

6.  Secondary:   Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)   [ Time Frame: through 12 weeks after first dose of study drug ]


  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
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  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Monitor
Organization: Vertex Pharmaceuticals Incorporated
phone: 1-617-444-6777
e-mail: medicalinfo@vrtx.com


No publications provided


Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00983853     History of Changes
Other Study ID Numbers: VX08-950-110
Study First Received: September 22, 2009
Results First Received: August 2, 2013
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices