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Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01440569
Recruitment Status : Completed
First Posted : September 26, 2011
Results First Posted : October 28, 2014
Last Update Posted : December 14, 2016
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acquired Immunodeficiency Syndrome
HIV Infections
Interventions Drug: COBI
Drug: DRV
Drug: NRTIs
Enrollment 314
Recruitment Details Participants were enrolled at a total of 56 study sites in the United States. The first participant was screened on 22 September 2011. The last study visit occurred on 30 October 2015.
Pre-assignment Details 397 participants were screened.
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase. Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Period Title: Main Study
Started 296 18
Enrolled and Treated 295 18
Completed 260 14
Not Completed 36 4
Reason Not Completed
Enrolled but not treated             1             0
Adverse Event             9             0
Pregnancy             1             0
Investigator's Discretion             1             1
Withdrew Consent             7             1
Lost to Follow-up             13             2
Subject Non-Compliance             3             0
Protocol Violation             1             0
Period Title: Open-Label Rollover Phase
Started 251 [1] 13 [2]
Completed 204 7
Not Completed 47 6
Reason Not Completed
Adverse Event             3             0
Pregnancy             1             0
Lack of Efficacy             2             0
Investigator’s Discretion             3             1
Withdrew Consent             11             1
Lost to Follow-up             26             3
Subject Non-Compliance             1             1
[1]
9 participants who completed the Main Study did not enroll into the Rollover Phase.
[2]
1 participant who completed the Main Study did not enroll into the Rollover Phase.
Arm/Group Title Treatment-Naive Treatment-Experienced Total
Hide Arm/Group Description Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase. Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase. Total of all reporting groups
Overall Number of Baseline Participants 295 18 313
Hide Baseline Analysis Population Description
Full Analysis Set: participants who were enrolled into the study and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants 18 participants 313 participants
36  (10.3) 45  (10.9) 36  (10.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 18 participants 313 participants
Female
29
   9.8%
5
  27.8%
34
  10.9%
Male
266
  90.2%
13
  72.2%
279
  89.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 18 participants 313 participants
Hispanic or Latino
64
  21.7%
4
  22.2%
68
  21.7%
Not Hispanic or Latino
231
  78.3%
14
  77.8%
245
  78.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 295 participants 18 participants 313 participants
White 176 11 187
Black or African Heritage 101 7 108
American Indian or Alaska Native 4 0 4
Asian 4 0 4
Native Hawaiian or Pacific Islander 2 0 2
Other 8 0 8
CD4 Count (cells/mm^3)  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 295 participants 18 participants 313 participants
378.2  (199.94) 197.8  (214.30) 367.8  (204.79)
HIV-1 RNA (log10 copies/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 295 participants 18 participants 313 participants
4.8  (0.76) 4.8  (1.04) 4.8  (0.78)
Background Antiretroviral Regimen   [1] 
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 295 participants 18 participants 313 participants
FTC/TDF 291 10 301
AZT+FTC/TDF 0 5 5
ABC+TDF 2 1 3
ABC+FTC/TDF 1 1 2
ABC/3TC 1 0 1
DDI+FTC 0 1 1
[1]
Measure Description: 3TC, lamivudine (Epivir®); ABC, abacavir; ABC/3TC, abacavir/lamivudine coformulation; AZT, azidothymidine or zidovudine; DDI, didanosine; FTC, emtricitabine (Emtriva®); FTC/TDF, emtricitabine/tenofovir disoproxil fumarate coformulation (Truvada®); TDF, tenofovir disoproxil fumarate (Viread®)
1.Primary Outcome
Title Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24
Hide Description [Not Specified]
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description:
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Overall Number of Participants Analyzed 295 18
Measure Type: Number
Unit of Measure: percentage of participants
5.4 11.1
2.Secondary Outcome
Title Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description:
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Overall Number of Participants Analyzed 295 18
Measure Type: Number
Unit of Measure: percentage of participants
83.7 61.1
3.Secondary Outcome
Title Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description:
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Overall Number of Participants Analyzed 295 18
Measure Type: Number
Unit of Measure: percentage of participants
82.7 50.0
4.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description:
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Overall Number of Participants Analyzed 295 18
Mean (Standard Deviation)
Unit of Measure: cells/μL
145  (131.6) 99  (161.9)
5.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description:
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Overall Number of Participants Analyzed 295 18
Mean (Standard Deviation)
Unit of Measure: cells/µL
194  (152.1) 121  (157.0)
6.Secondary Outcome
Title Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24
Hide Description [Not Specified]
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description:
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Overall Number of Participants Analyzed 295 18
Measure Type: Number
Unit of Measure: percentage of participants
Any treatment-emergent adverse event (TEAE) 88.1 83.3
Any TEAE that led to study drug discontinuation 5.1 0
7.Secondary Outcome
Title Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48
Hide Description [Not Specified]
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description:
Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
Overall Number of Participants Analyzed 295 18
Measure Type: Number
Unit of Measure: percentage of participants
Any treatment-emergent adverse event (TEAE) 91.5 88.9
Any TEAE that led to study drug discontinuation 5.4 0
Time Frame Up to a maximum of 204.4 weeks (average: 139.2 weeks)
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title Treatment-Naive Treatment-Experienced
Hide Arm/Group Description Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase. Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
All-Cause Mortality
Treatment-Naive Treatment-Experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment-Naive Treatment-Experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   45/295 (15.25%)   5/18 (27.78%) 
Blood and lymphatic system disorders     
Anaemia † 1  1/295 (0.34%)  0/18 (0.00%) 
Immune thrombocytopenic purpura † 1  1/295 (0.34%)  0/18 (0.00%) 
Cardiac disorders     
Acute myocardial infarction † 1  1/295 (0.34%)  0/18 (0.00%) 
Cardiac failure congestive † 1  1/295 (0.34%)  0/18 (0.00%) 
Coronary artery disease † 1  1/295 (0.34%)  0/18 (0.00%) 
Myocardial infarction † 1  1/295 (0.34%)  0/18 (0.00%) 
Supraventricular tachycardia † 1  1/295 (0.34%)  0/18 (0.00%) 
Eye disorders     
Retinal detachment † 1  1/295 (0.34%)  0/18 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  1/295 (0.34%)  0/18 (0.00%) 
Colitis † 1  2/295 (0.68%)  0/18 (0.00%) 
Constipation † 1  1/295 (0.34%)  0/18 (0.00%) 
Dysphagia † 1  1/295 (0.34%)  0/18 (0.00%) 
Gastritis † 1  1/295 (0.34%)  0/18 (0.00%) 
Nausea † 1  1/295 (0.34%)  0/18 (0.00%) 
Odynophagia † 1  1/295 (0.34%)  0/18 (0.00%) 
Vomiting † 1  1/295 (0.34%)  0/18 (0.00%) 
General disorders     
Hypothermia † 1  1/295 (0.34%)  0/18 (0.00%) 
Pain † 1  1/295 (0.34%)  0/18 (0.00%) 
Pyrexia † 1  2/295 (0.68%)  0/18 (0.00%) 
Hepatobiliary disorders     
Bile duct stone † 1  1/295 (0.34%)  0/18 (0.00%) 
Biliary dyskinesia † 1  1/295 (0.34%)  0/18 (0.00%) 
Cholecystitis acute † 1  1/295 (0.34%)  0/18 (0.00%) 
Immune system disorders     
Hypersensitivity † 1  1/295 (0.34%)  0/18 (0.00%) 
Immune reconstitution inflammatory syndrome † 1  1/295 (0.34%)  0/18 (0.00%) 
Infections and infestations     
Appendicitis † 1  1/295 (0.34%)  0/18 (0.00%) 
Cellulitis † 1  5/295 (1.69%)  1/18 (5.56%) 
Furuncle † 1  0/295 (0.00%)  1/18 (5.56%) 
Gangrene † 1  1/295 (0.34%)  0/18 (0.00%) 
Gastroenteritis † 1  1/295 (0.34%)  0/18 (0.00%) 
Influenza † 1  1/295 (0.34%)  0/18 (0.00%) 
Lung abscess † 1  1/295 (0.34%)  0/18 (0.00%) 
Osteomyelitis † 1  1/295 (0.34%)  0/18 (0.00%) 
Pelvic inflammatory disease † 1  1/295 (0.34%)  0/18 (0.00%) 
Perirectal abscess † 1  1/295 (0.34%)  0/18 (0.00%) 
Pharyngitis streptococcal † 1  1/295 (0.34%)  0/18 (0.00%) 
Pilonidal cyst † 1  1/295 (0.34%)  0/18 (0.00%) 
Pneumocystis jirovecii pneumonia † 1  1/295 (0.34%)  0/18 (0.00%) 
Pneumonia † 1  1/295 (0.34%)  1/18 (5.56%) 
Sepsis † 1  1/295 (0.34%)  0/18 (0.00%) 
Upper respiratory tract infection † 1  1/295 (0.34%)  0/18 (0.00%) 
Injury, poisoning and procedural complications     
Hip fracture † 1  1/295 (0.34%)  0/18 (0.00%) 
Laceration † 1  1/295 (0.34%)  0/18 (0.00%) 
Limb crushing injury † 1  1/295 (0.34%)  0/18 (0.00%) 
Limb injury † 1  1/295 (0.34%)  0/18 (0.00%) 
Toxicity to various agents † 1  1/295 (0.34%)  0/18 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1  0/295 (0.00%)  1/18 (5.56%) 
Diabetes mellitus † 1  1/295 (0.34%)  0/18 (0.00%) 
Diabetic ketoacidosis † 1  1/295 (0.34%)  0/18 (0.00%) 
Hypokalaemia † 1  1/295 (0.34%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Castleman's disease † 1  1/295 (0.34%)  0/18 (0.00%) 
Kaposi's sarcoma † 1  1/295 (0.34%)  0/18 (0.00%) 
Prostate cancer † 1  1/295 (0.34%)  0/18 (0.00%) 
Nervous system disorders     
Dizziness † 1  1/295 (0.34%)  0/18 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy † 1  1/295 (0.34%)  0/18 (0.00%) 
Psychiatric disorders     
Alcohol abuse † 1  0/295 (0.00%)  1/18 (5.56%) 
Alcoholism † 1  1/295 (0.34%)  0/18 (0.00%) 
Anxiety † 1  1/295 (0.34%)  0/18 (0.00%) 
Depression † 1  1/295 (0.34%)  0/18 (0.00%) 
Drug dependence † 1  0/295 (0.00%)  1/18 (5.56%) 
Mental status changes † 1  1/295 (0.34%)  0/18 (0.00%) 
Suicidal ideation † 1  2/295 (0.68%)  0/18 (0.00%) 
Suicide attempt † 1  4/295 (1.36%)  0/18 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis † 1  1/295 (0.34%)  0/18 (0.00%) 
Reproductive system and breast disorders     
Priapism † 1  1/295 (0.34%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash generalised † 1  1/295 (0.34%)  0/18 (0.00%) 
Rash maculo-papular † 1  1/295 (0.34%)  0/18 (0.00%) 
Vascular disorders     
Deep vein thrombosis † 1  1/295 (0.34%)  0/18 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment-Naive Treatment-Experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   261/295 (88.47%)   16/18 (88.89%) 
Blood and lymphatic system disorders     
Anaemia † 1  2/295 (0.68%)  2/18 (11.11%) 
Leukopenia † 1  0/295 (0.00%)  1/18 (5.56%) 
Ear and labyrinth disorders     
Ear discomfort † 1  0/295 (0.00%)  1/18 (5.56%) 
Eye disorders     
Angle closure glaucoma † 1  0/295 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Abdominal distension † 1  10/295 (3.39%)  1/18 (5.56%) 
Abdominal pain † 1  23/295 (7.80%)  1/18 (5.56%) 
Abdominal pain lower † 1  4/295 (1.36%)  1/18 (5.56%) 
Abdominal pain upper † 1  13/295 (4.41%)  1/18 (5.56%) 
Constipation † 1  13/295 (4.41%)  1/18 (5.56%) 
Diarrhoea † 1  99/295 (33.56%)  8/18 (44.44%) 
Faeces discoloured † 1  0/295 (0.00%)  1/18 (5.56%) 
Flatulence † 1  18/295 (6.10%)  1/18 (5.56%) 
Haemorrhoids † 1  22/295 (7.46%)  0/18 (0.00%) 
Inguinal hernia † 1  2/295 (0.68%)  1/18 (5.56%) 
Melaena † 1  0/295 (0.00%)  1/18 (5.56%) 
Nausea † 1  80/295 (27.12%)  3/18 (16.67%) 
Tongue pigmentation † 1  0/295 (0.00%)  1/18 (5.56%) 
Toothache † 1  9/295 (3.05%)  1/18 (5.56%) 
Vomiting † 1  34/295 (11.53%)  3/18 (16.67%) 
General disorders     
Chest pain † 1  12/295 (4.07%)  1/18 (5.56%) 
Fatigue † 1  35/295 (11.86%)  0/18 (0.00%) 
Pyrexia † 1  21/295 (7.12%)  3/18 (16.67%) 
Immune system disorders     
Seasonal allergy † 1  15/295 (5.08%)  0/18 (0.00%) 
Infections and infestations     
Acarodermatitis † 1  2/295 (0.68%)  1/18 (5.56%) 
Bronchitis † 1  33/295 (11.19%)  1/18 (5.56%) 
Conjunctivitis † 1  16/295 (5.42%)  0/18 (0.00%) 
Folliculitis † 1  16/295 (5.42%)  0/18 (0.00%) 
Gastroenteritis viral † 1  6/295 (2.03%)  1/18 (5.56%) 
Herpes zoster † 1  7/295 (2.37%)  1/18 (5.56%) 
Influenza † 1  20/295 (6.78%)  2/18 (11.11%) 
Lower respiratory tract infection † 1  0/295 (0.00%)  1/18 (5.56%) 
Nasopharyngitis † 1  37/295 (12.54%)  4/18 (22.22%) 
Onychomycosis † 1  7/295 (2.37%)  1/18 (5.56%) 
Pharyngitis † 1  24/295 (8.14%)  0/18 (0.00%) 
Rash pustular † 1  0/295 (0.00%)  1/18 (5.56%) 
Sinusitis † 1  33/295 (11.19%)  4/18 (22.22%) 
Syphilis † 1  25/295 (8.47%)  0/18 (0.00%) 
Tooth abscess † 1  10/295 (3.39%)  2/18 (11.11%) 
Upper respiratory tract infection † 1  70/295 (23.73%)  2/18 (11.11%) 
Vaginal infection † 1  1/295 (0.34%)  1/18 (5.56%) 
Vulvovaginitis † 1  0/295 (0.00%)  1/18 (5.56%) 
Vulvovaginitis trichomonal † 1  1/295 (0.34%)  1/18 (5.56%) 
Injury, poisoning and procedural complications     
Arthropod bite † 1  4/295 (1.36%)  1/18 (5.56%) 
Contusion † 1  7/295 (2.37%)  1/18 (5.56%) 
Incision site pain † 1  1/295 (0.34%)  1/18 (5.56%) 
Laceration † 1  5/295 (1.69%)  1/18 (5.56%) 
Investigations     
Weight decreased † 1  4/295 (1.36%)  2/18 (11.11%) 
Metabolism and nutrition disorders     
Abnormal loss of weight † 1  1/295 (0.34%)  1/18 (5.56%) 
Decreased appetite † 1  7/295 (2.37%)  1/18 (5.56%) 
Hypertriglyceridaemia † 1  7/295 (2.37%)  1/18 (5.56%) 
Vitamin D deficiency † 1  10/295 (3.39%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  20/295 (6.78%)  0/18 (0.00%) 
Back pain † 1  23/295 (7.80%)  1/18 (5.56%) 
Groin pain † 1  1/295 (0.34%)  1/18 (5.56%) 
Muscular weakness † 1  3/295 (1.02%)  1/18 (5.56%) 
Myalgia † 1  7/295 (2.37%)  1/18 (5.56%) 
Pain in jaw † 1  1/295 (0.34%)  1/18 (5.56%) 
Spinal osteoarthritis † 1  0/295 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anogenital warts † 1  20/295 (6.78%)  1/18 (5.56%) 
Basal cell carcinoma † 1  2/295 (0.68%)  1/18 (5.56%) 
Penile wart † 1  2/295 (0.68%)  1/18 (5.56%) 
Squamous cell carcinoma of the vulva † 1  0/295 (0.00%)  1/18 (5.56%) 
Uterine leiomyoma † 1  2/295 (0.68%)  1/18 (5.56%) 
Nervous system disorders     
Amnesia † 1  3/295 (1.02%)  1/18 (5.56%) 
Cerebral atrophy † 1  0/295 (0.00%)  1/18 (5.56%) 
Facial paresis † 1  0/295 (0.00%)  1/18 (5.56%) 
Headache † 1  50/295 (16.95%)  3/18 (16.67%) 
Post herpetic neuralgia † 1  1/295 (0.34%)  1/18 (5.56%) 
Psychiatric disorders     
Abnormal dreams † 1  12/295 (4.07%)  1/18 (5.56%) 
Alcohol abuse † 1  0/295 (0.00%)  1/18 (5.56%) 
Anxiety † 1  19/295 (6.44%)  3/18 (16.67%) 
Depression † 1  37/295 (12.54%)  0/18 (0.00%) 
Drug dependence † 1  0/295 (0.00%)  1/18 (5.56%) 
Insomnia † 1  18/295 (6.10%)  1/18 (5.56%) 
Renal and urinary disorders     
Dysuria † 1  6/295 (2.03%)  1/18 (5.56%) 
Proteinuria † 1  3/295 (1.02%)  1/18 (5.56%) 
Reproductive system and breast disorders     
Erectile dysfunction † 1  8/295 (2.71%)  1/18 (5.56%) 
Uterine malposition † 1  0/295 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Bronchial hyperreactivity † 1  0/295 (0.00%)  1/18 (5.56%) 
Cough † 1  27/295 (9.15%)  2/18 (11.11%) 
Dyspnoea exertional † 1  0/295 (0.00%)  1/18 (5.56%) 
Lower respiratory tract congestion † 1  1/295 (0.34%)  2/18 (11.11%) 
Nasal congestion † 1  7/295 (2.37%)  1/18 (5.56%) 
Nasal oedema † 1  0/295 (0.00%)  1/18 (5.56%) 
Oropharyngeal pain † 1  20/295 (6.78%)  0/18 (0.00%) 
Productive cough † 1  3/295 (1.02%)  1/18 (5.56%) 
Rhinitis allergic † 1  8/295 (2.71%)  2/18 (11.11%) 
Rhinorrhoea † 1  5/295 (1.69%)  1/18 (5.56%) 
Sinus congestion † 1  17/295 (5.76%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders     
Dry skin † 1  12/295 (4.07%)  2/18 (11.11%) 
Hand dermatitis † 1  0/295 (0.00%)  1/18 (5.56%) 
Night sweats † 1  7/295 (2.37%)  1/18 (5.56%) 
Pruritus † 1  13/295 (4.41%)  1/18 (5.56%) 
Rash † 1  39/295 (13.22%)  1/18 (5.56%) 
Rash maculo-papular † 1  5/295 (1.69%)  1/18 (5.56%) 
Skin hyperpigmentation † 1  0/295 (0.00%)  1/18 (5.56%) 
Skin lesion † 1  2/295 (0.68%)  3/18 (16.67%) 
Urticaria † 1  3/295 (1.02%)  2/18 (11.11%) 
Surgical and medical procedures     
Tooth extraction † 1  1/295 (0.34%)  1/18 (5.56%) 
Vascular disorders     
Hypertension † 1  17/295 (5.76%)  0/18 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
[Not Specified]
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01440569     History of Changes
Other Study ID Numbers: GS-US-216-0130
2011-003501-22 ( EudraCT Number )
First Submitted: September 22, 2011
First Posted: September 26, 2011
Results First Submitted: October 23, 2014
Results First Posted: October 28, 2014
Last Update Posted: December 14, 2016