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Elvucitabine/Efavirenz/Tenofovir vs. Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected, Treatment Naive Subjects

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ClinicalTrials.gov Identifier: NCT00350272
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : March 22, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Achillion Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: elvucitabine
Drug: Lamivudine
Drug: Tenofovir
Drug: Efavirenz
Enrollment 76
Recruitment Details HIV-1–infected, treatment-naïve adults with no AIDS-defining events in the 3 months prior to Screening and with plasma HIV-1 RNA levels greater than or equal to 5000 copies/mL and CD4 counts greater than or equal to 200 cells/μL and less than 500 cells/μL and HIV-1 strains absent the M184V, M184I, D237E, K103, Y188L, and K65R mutations at Screen.
Pre-assignment Details A total of 78 were given a treatment assignment. One subject assigned to treatment was ineligible for randomization and did not receive any study drug. An additional subject did not take any of the dispensed study drug. Therefore 76 subjects were treated.
Arm/Group Title Elvucitabine, Efavirenz,Tenofovir Lamivudine,Efavirenz,Tenofovir
Hide Arm/Group Description Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96). Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
Period Title: Blinded 12 Week Treatment
Started 39 37
Completed 30 35
Not Completed 9 2
Reason Not Completed
Adverse Event             1             0
Death             1             0
Lost to Follow-up             2             0
Withdrawal by Subject             3             0
Physician Decision             2             1
Sponsor decision             0             1
Period Title: Open-Label 84 Week Treatment
Started 30 35
Completed 21 27
Not Completed 9 8
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             3             2
Withdrawal by Subject             1             2
Physician Decision             1             2
Sponsor decision             2             1
Arm/Group Title Lamivudine Elvucitabine Total
Hide Arm/Group Description Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96). Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96). Total of all reporting groups
Overall Number of Baseline Participants 37 39 76
Hide Baseline Analysis Population Description
The baseline analysis population was the safety population, defined as all randomized subjects who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 39 participants 76 participants
36.4  (11.34) 37.1  (10.20) 36.6  (10.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
Female
8
  21.6%
7
  17.9%
15
  19.7%
Male
29
  78.4%
32
  82.1%
61
  80.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
Hispanic or Latino
8
  21.6%
13
  33.3%
21
  27.6%
Not Hispanic or Latino
29
  78.4%
26
  66.7%
55
  72.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 39 participants 76 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
10
  27.0%
9
  23.1%
19
  25.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  16.2%
7
  17.9%
13
  17.1%
White
21
  56.8%
22
  56.4%
43
  56.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   2.6%
1
   1.3%
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 37 participants 39 participants 76 participants
67.33  (4.325) 68.18  (4.433) 67.77  (4.373)
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 37 participants 39 participants 76 participants
171.37  (52.582) 162.03  (41.272) 166.58  (47.035)
1.Primary Outcome
Title The Proportion of Subjects With Virologic Response for 10 mg/Day Elvucitabine in HIV-1-infected Subjects by 12 Weeks Compared With the Proportion of Subjects With Lamivudine 300 mg/Day.
Hide Description Proportion of subjects having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected subjects over 12 weeks compared with the proportion of subjects having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This primary outcome measure used the intent-to-treat population, defined as all randomized subjects who took at least 1 dose of study drug and had both a baseline HIV-1 RNA result and at least 1 HIV-1 RNA result after baseline assessment. For this analysis, all subjects who discontinued from the study before Week 12 were considered as NC=F.
Arm/Group Title Lamivudine Elvucitabine
Hide Arm/Group Description:
Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
Overall Number of Participants Analyzed 37 37
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 8.1 13.5
Week 4 10.8 16.2
Week 6 35.1 27.0
Week 8 54.1 35.1
Week 10 56.8 54.1
Week 12 70.3 56.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamivudine, Elvucitabine
Comments Difference in proportions between the group of subjects who received lamivudine 300 m/day (in combination with efavirenz and tenofovir) over 12 weeks and the group of subjects who received elvucitabine 10.mg/day (in combination with efavirenz and tenofovir) over 12 weeks along with corresponding 2-sided 95% confidence interval for risk difference using asymptotic normal theory.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -13.5
Confidence Interval (2-Sided) 95%
-35.2 to 8.2
Estimation Comments [Not Specified]
2.Primary Outcome
Title The Safety Profile of Elvucitabine.
Hide Description Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events and the frequency of Grade 3 and Grade 4 laboratory abnormalities.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug.
Arm/Group Title Elvucitabine, Efavirenz,Tenofovir Lamivudine,Efavirenz,Tenofovir
Hide Arm/Group Description:
Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
Overall Number of Participants Analyzed 39 37
Measure Type: Number
Unit of Measure: participants
Treatment emergent adverse events 36 35
Treatment emergent severe adverse events 3 2
Treatment related serious adverse events 0 0
Discontinuations due to adverse events 2 0
Treatment emergent Grade 3/4 lab abnormalities 6 5
Time Frame Adverse event data were collected from enrollment into the study to 96 weeks.
Adverse Event Reporting Description Treatment-emergent adverse events are summarized.
 
Arm/Group Title Lamivudine Elvucitabine
Hide Arm/Group Description Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96). Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
All-Cause Mortality
Lamivudine Elvucitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lamivudine Elvucitabine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/37 (13.51%)      10/39 (25.64%)    
Blood and lymphatic system disorders     
Anaemia  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Gastrointestinal disorders     
Diverticulum  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Enterocutaneous fistula  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Irritable bowel syndrome  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Oesophagitis  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Infections and infestations     
Appendicitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Bronchitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Bronchitis acute  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Diverticulitis  1  1/37 (2.70%)  3 0/39 (0.00%)  0
Influenza  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Pneumonia  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Pyelonephritis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Tonsillitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Injury, poisoning and procedural complications     
Multiple drug overdose intentional  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Post procedural haematoma  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Upper limb fracture  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Wound dehiscence  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fracture nonunion  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Castleman's disease  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Psychiatric disorders     
Bipolar disorder  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Completed suicide  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lamivudine Elvucitabine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/37 (94.59%)      37/39 (94.87%)    
Blood and lymphatic system disorders     
Anaemia  1  1/37 (2.70%)  3 0/39 (0.00%)  0
Neutropenia  1  1/37 (2.70%)  3 0/39 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  2/37 (5.41%)  2 1/39 (2.56%)  1
Bradycardia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Palpitations  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Congenital, familial and genetic disorders     
Hydrocele  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Ear and labyrinth disorders     
Auricular swelling  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Cerumen impaction  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Ear haemorrhage  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Endocrine disorders     
Hypogonadism  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Eye disorders     
Conjunctivitis  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Eye irritation  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Eye pruritus  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Lacrimation increased  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Scleral hyperaemia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Gastrointestinal disorders     
Abdominal distension  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Abdominal pain  1  1/37 (2.70%)  1 3/39 (7.69%)  5
Abdominal pain lower  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Abdominal pain upper  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Anal fissure  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Anal skin tags  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Anogenital dysplasia  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Apththous stomatitis  1  1/37 (2.70%)  1 2/39 (5.13%)  2
Constipation  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Diarrhoea  1  12/37 (32.43%)  15 7/39 (17.95%)  11
Dry mouth  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Dyspepsia  1  2/37 (5.41%)  4 3/39 (7.69%)  3
Dysphagia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Eructation  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Flatulence  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Food poisoning  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Gastritis  1  3/37 (8.11%)  4 0/39 (0.00%)  0
Gastrooesophageal reflux disease  1  3/37 (8.11%)  3 2/39 (5.13%)  2
Gingival bleeding  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Gingivitis  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Haemorrhoids  1  3/37 (8.11%)  3 2/39 (5.13%)  2
Hypoaesthesia oral  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Irritable bowel syndrome  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Mouth ulceration  1  3/37 (8.11%)  3 0/39 (0.00%)  0
Nausea  1  8/37 (21.62%)  10 10/39 (25.64%)  13
Oral pain  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Painful defaecation  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Rectal haemorrhage  1  0/37 (0.00%)  0 3/39 (7.69%)  3
Reflux oesophagitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Salivary gland mass  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Tongue ulceration  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Toothache  1  3/37 (8.11%)  4 0/39 (0.00%)  0
Varices oesophageal  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Vomiting  1  7/37 (18.92%)  8 6/39 (15.38%)  8
General disorders     
Asthenia  1  1/37 (2.70%)  1 3/39 (7.69%)  3
Chills  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Fatigue  1  3/37 (8.11%)  6 4/39 (10.26%)  4
Feeling drunk  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Feeling of body temperature change  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Influenza like illness  1  3/37 (8.11%)  3 2/39 (5.13%)  4
Injection site reaction  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Malaise  1  2/37 (5.41%)  2 1/39 (2.56%)  1
Non-cardiac chest pain  1  2/37 (5.41%)  2 3/39 (7.69%)  3
Oedema peripheral  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Pain  1  2/37 (5.41%)  5 1/39 (2.56%)  1
Pyrexia  1  8/37 (21.62%)  13 4/39 (10.26%)  7
Hepatobiliary disorders     
Hepatic lesion  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Hepatomegaly  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Immune system disorders     
Allergy to arthropod bite  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Drug hypersensitivity  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Seasonal allergy  1  2/37 (5.41%)  2 1/39 (2.56%)  1
Infections and infestations     
Abscess  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Abscess limb  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Acarodermatitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Acute sinusitis  1  2/37 (5.41%)  2 1/39 (2.56%)  3
Body tinea  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Bronchitis  1  6/37 (16.22%)  9 4/39 (10.26%)  4
Bronchitis acute  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Bronchitis chronic  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Candidiasis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Cellulitis  1  2/37 (5.41%)  2 1/39 (2.56%)  1
Condyloma acuminatum  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Diverticulitis  1  1/37 (2.70%)  6 0/39 (0.00%)  0
Ear infection  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Eye infection  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Folliculitis  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Gastroenteritis  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Gastroenteritis viral  1  2/37 (5.41%)  2 1/39 (2.56%)  1
Gonorrhoea  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Herpes simplex  1  1/37 (2.70%)  1 3/39 (7.69%)  3
Herpes zoster  1  0/37 (0.00%)  0 4/39 (10.26%)  4
Hordeolum  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Influenza  1  1/37 (2.70%)  2 1/39 (2.56%)  1
Lobar pneumonia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Lower respiratory tract infection  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Mastitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Nasopharyngitis  1  2/37 (5.41%)  5 1/39 (2.56%)  2
Onychomycosis  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Oral candidiasis  1  2/37 (5.41%)  2 3/39 (7.69%)  5
Otitis externa  1  0/37 (0.00%)  0 1/39 (2.56%)  2
Otitis media  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Paronychia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Periorbital cellulitis  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Pharyngitis  1  2/37 (5.41%)  4 2/39 (5.13%)  3
Pneumonia  1  0/37 (0.00%)  0 1/39 (2.56%)  2
Pyoderma  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Rhinitis  1  1/37 (2.70%)  1 2/39 (5.13%)  2
Sinusitis  1  6/37 (16.22%)  7 4/39 (10.26%)  4
Staphylococcal infection  1  0/37 (0.00%)  0 1/39 (2.56%)  3
Tinea infection  1  2/37 (5.41%)  2 1/39 (2.56%)  1
Tinea pedis  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Tinea versicolour  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Tooth abscess  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Tracheobronchitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Tuberculosis gastrointestinal  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Upper respiratory tract infection  1  11/37 (29.73%)  14 7/39 (17.95%)  8
Urinary tract infection  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Viral infection  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Vulvovaginal mycotic infection  1  1/37 (2.70%)  2 0/39 (0.00%)  0
Injury, poisoning and procedural complications     
Arthropod bite  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Back injury  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Chest injury  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Corneal abrasion  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Excoriation  1  1/37 (2.70%)  2 0/39 (0.00%)  0
Fall  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Foot fracture  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Head injury  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Joint injury  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Limb injury  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Mouth injury  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Muscle strain  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Post procedural discharge  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Post procedural haematoma  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Post procedural oedema  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Procedural pain  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Rib fracture  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Thermal burn  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Tooth fracture  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Wound dehiscence  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Investigations     
Blood amylase increased  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Blood cholesterol increased  1  1/37 (2.70%)  4 2/39 (5.13%)  3
Blood creatine phosphokinase  1  0/37 (0.00%)  0 1/39 (2.56%)  3
Blood phosphorus decreased  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Blood sodium decreased  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Blood triglycerides increased  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Blood urine present  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Cardiac murmur  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Hepatic enzyme increased  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Lipase increased  1  2/37 (5.41%)  4 2/39 (5.13%)  4
Low density lipoprotein increased  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Neutrophil count decreased  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Occult blood positive  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Smear cervix abnormal  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Tuberculin test positive  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Weight decreased  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  3/37 (8.11%)  3 3/39 (7.69%)  3
Dyslipidaemia  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Gout  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Hypercholesterolaemia  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Hyperlipidaemia  1  4/37 (10.81%)  10 1/39 (2.56%)  1
Hypertriglyceridaemia  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Increased appetite  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/37 (10.81%)  7 4/39 (10.26%)  4
Arthropathy  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Back pain  1  2/37 (5.41%)  3 3/39 (7.69%)  4
Intervertebral disc degeneration  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Muscle spasms  1  5/37 (13.51%)  6 2/39 (5.13%)  2
Musculoskeletal chest pain  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Musculoskeletal discomfort  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Myalgia  1  2/37 (5.41%)  4 0/39 (0.00%)  0
Neck pain  1  2/37 (5.41%)  2 1/39 (2.56%)  2
Pain in extremity  1  6/37 (16.22%)  8 4/39 (10.26%)  7
Shoulder pain  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Tendonitis  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Melanocytic naevus  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Skin papilloma  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Nervous system disorders     
Disturbance in attention  1  1/37 (2.70%)  2 0/39 (0.00%)  0
Dizziness  1  9/37 (24.32%)  13 8/39 (20.51%)  10
Headache  1  7/37 (18.92%)  10 9/39 (23.08%)  12
Hypoaesthesia  1  1/37 (2.70%)  1 1/39 (2.56%)  2
Hypokinesia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Migraine  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Nerve compression  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Neuralgia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Neuropathy peripheral  1  4/37 (10.81%)  6 0/39 (0.00%)  0
Paraesthesia  1  1/37 (2.70%)  1 2/39 (5.13%)  2
Parosmia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Post herpetic neuralgia  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Somnolence  1  2/37 (5.41%)  2 1/39 (2.56%)  1
Psychiatric disorders     
Abnormal dreams  1  8/37 (21.62%)  8 3/39 (7.69%)  3
Anxiety  1  4/37 (10.81%)  6 1/39 (2.56%)  1
Attention deficit/hyperactivity disorder  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Depressed mood  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Depression  1  3/37 (8.11%)  3 4/39 (10.26%)  4
Disorientation  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Euphoric mood  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Hallucination  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Insomnia  1  6/37 (16.22%)  6 5/39 (12.82%)  6
Loss of libido  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Mania  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Mood swings  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Nightmare  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Panic attack  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Premature ejaculation  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Stress  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Suicidal ideation  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Renal and urinary disorders     
Dysuria  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Haematuria  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Pollakiuria  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Urethral ulcer  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Reproductive system and breast disorders     
Amenorrhoea  1  1/37 (2.70%)  2 0/39 (0.00%)  0
Breast mass  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Breast microcalcification  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Epididymitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Genital pruritus female  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Genital ulceration  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Gynaecomastia  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Nipple pain  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Prostatitis  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Pruritus genital  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Vaginal discharge  1  0/37 (0.00%)  0 1/39 (2.56%)  2
Vaginal mucosal blistering  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic sinusitis  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Asthma  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Cough  1  8/37 (21.62%)  8 8/39 (20.51%)  9
Dry throat  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Nasal congestion  1  0/37 (0.00%)  0 2/39 (5.13%)  2
Pharyngeal erythema  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Pharyngolaryngeal pain  1  3/37 (8.11%)  3 4/39 (10.26%)  5
Productive cough  1  4/37 (10.81%)  5 3/39 (7.69%)  5
Pulmonary congestion  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Respiratory tract congestion  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Rhinitis allergic  1  1/37 (2.70%)  2 3/39 (7.69%)  3
Rhinorrhoea  1  4/37 (10.81%)  4 2/39 (5.13%)  2
Sinus congestion  1  3/37 (8.11%)  5 2/39 (5.13%)  4
Skin and subcutaneous tissue disorders     
Acne  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Dermatitis  1  2/37 (5.41%)  2 1/39 (2.56%)  1
Dermatitis contact  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Dry skin  1  1/37 (2.70%)  1 1/39 (2.56%)  1
Eosinophilic pustular folliculitis  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Heat rash  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Night sweats  1  1/37 (2.70%)  1 2/39 (5.13%)  2
Pruritus  1  4/37 (10.81%)  4 3/39 (7.69%)  4
Rash  1  6/37 (16.22%)  7 2/39 (5.13%)  2
Rash erythematous  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Rash macular  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Rash maculo-papular  1  2/37 (5.41%)  2 0/39 (0.00%)  0
Rash papular  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Scar  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Skin discolouration  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Skin hyperpigmentation  1  0/37 (0.00%)  0 4/39 (10.26%)  4
Skin lesion  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Urticaria  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Social circumstances     
Drug abuser  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Physical abuse  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Vascular disorders     
Hot flush  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Hypertension  1  0/37 (0.00%)  0 5/39 (12.82%)  5
Raynaud's phenomenon  1  0/37 (0.00%)  0 1/39 (2.56%)  1
Varicose vein  1  1/37 (2.70%)  1 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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.
Prior to submitting/presenting a manuscript or materials relating to a Study to a publisher, reviewer, or outside person, the Institution shall provide to Achillion a copy of all such manuscripts or materials, and Achillion shall have thirty (30) days to review and comment. The Institution shall, upon Achillion's request, further delay publication or presentation for a period of up to sixty (60) days to allow Achillion to protect its interests in any Achillion Inventions.
Results Point of Contact
Name/Title: Kevin Kucharski, VP of Clinical Operations
Organization: Achillion Pharmaceuticals, Inc.
Phone: 203-624-7000
Responsible Party: Achillion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00350272     History of Changes
Other Study ID Numbers: ACH443-015
First Submitted: July 6, 2006
First Posted: July 10, 2006
Results First Submitted: February 22, 2016
Results First Posted: March 22, 2016
Last Update Posted: June 17, 2016