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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
History of Changes
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
No text entered.

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
Measure Description No text entered.
Time Frame 12 weeks after last dose of study drug  
Safety Issue No  

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.
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.

Measured Values
    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  
Number of Participants Analyzed  
[units: participants]
 		  7     6     16     8     15     8  
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment  
[units: participants]
 		           
SVR12     5     2     11     4     12     4  
SVR24     5     2     11     4     12     4  

No statistical analysis provided for Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment



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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  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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