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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

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ClinicalTrials.gov Identifier: NCT00983853
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : October 10, 2013
Last Update Posted : October 10, 2013
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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)
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 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
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

Period Title: Overall Study
Started 7 7 [1] 17 [1] 8 15 8
Completed 6 5 14 6 12 7
Not Completed 1 2 3 2 3 1
Reason Not Completed
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
Arm/Group Title 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
Hide Arm/Group Description Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART. Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 7 6 16 8 15 8 60
Hide Baseline Analysis Population Description
All randomized subjects who received at least 1 dose of study drug
Age Continuous  
Median (Full Range)
Unit of measure:  Years
median (min, max) Number Analyzed 7 participants 6 participants 16 participants 8 participants 15 participants 8 participants 60 participants
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 16 participants 8 participants 15 participants 8 participants 60 participants
Female
1
  14.3%
2
  33.3%
0
   0.0%
1
  12.5%
2
  13.3%
1
  12.5%
7
  11.7%
Male
6
  85.7%
4
  66.7%
16
 100.0%
7
  87.5%
13
  86.7%
7
  87.5%
53
  88.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 16 participants 8 participants 15 participants 8 participants 60 participants
Hispanic or Latino
3
  42.9%
2
  33.3%
5
  31.3%
1
  12.5%
3
  20.0%
3
  37.5%
17
  28.3%
Not Hispanic or Latino
4
  57.1%
4
  66.7%
10
  62.5%
7
  87.5%
12
  80.0%
5
  62.5%
42
  70.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 16 participants 8 participants 15 participants 8 participants 60 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 16 participants 8 participants 15 participants 8 participants 60 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
1.Primary Outcome
Title Proportion of Subjects Achieving Undetectable HCV RNA at Week 12
Hide Description [Not Specified]
Time Frame 12 weeks after first dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 dose of study drug
Arm/Group Title 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
Hide Arm/Group Description:
Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
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.
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.
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.
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.
Overall Number of Participants Analyzed 7 6 16 8 15 8
Measure Type: Number
Unit of Measure: participants
6 2 14 2 10 2
2.Secondary Outcome
Title Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12
Hide Description number of subjects with undetectable HCV RNA
Time Frame 4 and 12 weeks after the first dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized and received at least 1 dose of study drug
Arm/Group Title 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
Hide Arm/Group Description:
Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
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.
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.
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.
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.
Overall Number of Participants Analyzed 7 6 16 8 15 8
Measure Type: Number
Unit of Measure: participants
Week 4 (RVR) 5 0 12 0 9 0
Weeks 4 and 12 (eRVR) 4 0 12 0 7 0
3.Secondary Outcome
Title Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment
Hide Description [Not Specified]
Time Frame 12 weeks after last dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
subjects who received at least 1 dose of study drug.
Arm/Group Title 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
Hide Arm/Group Description:
Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
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.
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.
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.
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.
Overall Number of Participants Analyzed 7 6 16 8 15 8
Measure Type: Number
Unit of Measure: participants
SVR12 5 2 11 4 12 4
SVR24 5 2 11 4 12 4
4.Secondary Outcome
Title Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure
Hide Description [Not Specified]
Time Frame through 12 weeks after first dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
subjects with available plasma concentration data
Arm/Group Title EFV-based (Test, N=15) vs No HAART (Reference, N=7) ATV/R-based (Test, N=13) vs No HAART (Reference, N=7)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 15 13
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ratio (test/reference)
Cmin
0.8842
(0.5467 to 1.4300)
1.3059
(0.7981 to 2.1367)
Cavg
0.9610
(0.6615 to 1.3961)
1.0930
(0.7456 to 1.6023)
Cmax
1.0061
(0.7306 to 1.3855)
1.0075
(0.7260 to 1.3982)
5.Secondary Outcome
Title Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)
Hide Description Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)
Time Frame through 12 weeks after first dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
subjects with available concentration data
Arm/Group Title T/PR Pbo/PR
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 8
Median (Full Range)
Unit of Measure: ratio (test/reference)
Efavirenz
0.94
(0.42 to 2.84)
0.79
(0.48 to 1.48)
Tenofovir
1.06
(0.46 to 17.4)
0.64
(0.30 to 2.01)
6.Secondary Outcome
Title Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)
Hide Description Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)
Time Frame through 12 weeks after first dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
subjects with available concentration data
Arm/Group Title T/PR Pbo/PR
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 13 7
Median (Full Range)
Unit of Measure: ratio (test/reference)
Atazanavir (N=12 T/PR, N=6 Pbo/PR)
1.16
(0.39 to 45.0)
1.03
(0.49 to 2.05)
Tenofovir (N=13 T/PR, N=7 Pbo/PR)
0.75
(0.28 to 40.7)
0.93
(0.55 to 1.68)
Ritonavir (N=9 T/PR, N=7 Pbo/PR)
0.72
(0.08 to 4.40)
0.74
(0.21 to 4.20)
Time Frame first dose of study drug until 4 weeks after the last dose of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T/PR Total PR
Hide Arm/Group Description Pooled T/PR from Part A and Part B Pooled PR from Part A and Part B
All-Cause Mortality
T/PR Total PR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T/PR Total PR
Affected / at Risk (%) Affected / at Risk (%)
Total   7/38 (18.42%)   2/22 (9.09%) 
Blood and lymphatic system disorders     
Anaemia  0/38 (0.00%)  1/22 (4.55%) 
Hemolytic Anemia  1/38 (2.63%)  0/22 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction  1/38 (2.63%)  0/22 (0.00%) 
Gastrointestinal disorders     
Peritonitis  0/38 (0.00%)  1/22 (4.55%) 
General disorders     
Non-cardiac Chest Pain  1/38 (2.63%)  0/22 (0.00%) 
Infections and infestations     
Groin Infection  1/38 (2.63%)  0/22 (0.00%) 
Appendicitis  0/38 (0.00%)  1/22 (4.55%) 
Pyelonephritis Acute  1/38 (2.63%)  0/22 (0.00%) 
Cellulitis Staphylococcal  1/38 (2.63%)  0/22 (0.00%) 
Staphylococcal Abscess  1/38 (2.63%)  0/22 (0.00%) 
Staphylococcal Infection  1/38 (2.63%)  0/22 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1/38 (2.63%)  0/22 (0.00%) 
Hyponatraemia  1/38 (2.63%)  0/22 (0.00%) 
Reproductive system and breast disorders     
Epididymitis  1/38 (2.63%)  0/22 (0.00%) 
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T/PR Total PR
Affected / at Risk (%) Affected / at Risk (%)
Total   38/38 (100.00%)   22/22 (100.00%) 
Blood and lymphatic system disorders     
Neutropenia  9/38 (23.68%)  5/22 (22.73%) 
Anaemia  6/38 (15.79%)  3/22 (13.64%) 
Endocrine disorders     
Hypothyroidism  2/38 (5.26%)  0/22 (0.00%) 
Eye disorders     
Cheilitis  2/38 (5.26%)  0/22 (0.00%) 
Gastrointestinal disorders     
Nausea  13/38 (34.21%)  5/22 (22.73%) 
Diarrhoea  9/38 (23.68%)  4/22 (18.18%) 
Vomiting  7/38 (18.42%)  2/22 (9.09%) 
Abdominal Pain Upper  5/38 (13.16%)  0/22 (0.00%) 
Gastrooesophageal Reflux Disease  0/38 (0.00%)  3/22 (13.64%) 
Anogenital Dysplasia  0/38 (0.00%)  2/22 (9.09%) 
Dry Mouth  2/38 (5.26%)  0/22 (0.00%) 
Haemorrhoids  2/38 (5.26%)  0/22 (0.00%) 
General disorders     
Chills  6/38 (15.79%)  4/22 (18.18%) 
Pyrexia  8/38 (21.05%)  2/22 (9.09%) 
Influenza-like Illness  5/38 (13.16%)  3/22 (13.64%) 
Irritability  5/38 (13.16%)  3/22 (13.64%) 
Fatigue  16/38 (42.11%)  9/22 (40.91%) 
Injection Site Erythema  2/38 (5.26%)  1/22 (4.55%) 
Pain  1/38 (2.63%)  3/22 (13.64%) 
Malaise  2/38 (5.26%)  0/22 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  2/38 (5.26%)  0/22 (0.00%) 
Jaundice  2/38 (5.26%)  0/22 (0.00%) 
Infections and infestations     
Nasopharyngitis  2/38 (5.26%)  1/22 (4.55%) 
Fungal Skin Infection  2/38 (5.26%)  0/22 (0.00%) 
Sinusitis  2/38 (5.26%)  0/22 (0.00%) 
Investigations     
Weight Decreased  5/38 (13.16%)  5/22 (22.73%) 
Blood Bilirubin Increased  2/38 (5.26%)  0/22 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite  4/38 (10.53%)  4/22 (18.18%) 
Anorexia  4/38 (10.53%)  1/22 (4.55%) 
Hypertriglyceridaemia  2/38 (5.26%)  0/22 (0.00%) 
Hypokalaemia  2/38 (5.26%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia  6/38 (15.79%)  5/22 (22.73%) 
Back Pain  3/38 (7.89%)  1/22 (4.55%) 
Arthralgia  2/38 (5.26%)  0/22 (0.00%) 
Muscle Spasms  0/38 (0.00%)  2/22 (9.09%) 
Nervous system disorders     
Headache  14/38 (36.84%)  6/22 (27.27%) 
Dizziness  8/38 (21.05%)  3/22 (13.64%) 
Paraesthesia  0/38 (0.00%)  2/22 (9.09%) 
Psychiatric disorders     
Depression  8/38 (21.05%)  2/22 (9.09%) 
Insomnia  5/38 (13.16%)  5/22 (22.73%) 
Anxiety  3/38 (7.89%)  1/22 (4.55%) 
Depressed Mood  1/38 (2.63%)  3/22 (13.64%) 
Affect Lability  2/38 (5.26%)  0/22 (0.00%) 
Libido Decreased  2/38 (5.26%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  3/38 (7.89%)  3/22 (13.64%) 
Dyspnoea Exertional  1/38 (2.63%)  2/22 (9.09%) 
Pharyngeal Pain  2/38 (5.26%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  15/38 (39.47%)  2/22 (9.09%) 
Rash  5/38 (13.16%)  2/22 (9.09%) 
Alopecia  4/38 (10.53%)  2/22 (9.09%) 
Dry Skin  2/38 (5.26%)  1/22 (4.55%) 
Night Sweats  2/38 (5.26%)  1/22 (4.55%) 
Erythema  2/38 (5.26%)  0/22 (0.00%) 
Dermatitis  1/38 (2.63%)  2/22 (9.09%) 
1
Term from vocabulary, MedDRA (11.0)
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.
Results Point of Contact
Name/Title: Medical Monitor
Organization: Vertex Pharmaceuticals Incorporated
Phone: 1-617-444-6777
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00983853     History of Changes
Other Study ID Numbers: VX08-950-110
First Submitted: September 22, 2009
First Posted: September 24, 2009
Results First Submitted: August 2, 2013
Results First Posted: October 10, 2013
Last Update Posted: October 10, 2013