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Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT01497899
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : January 8, 2016
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Acquired Immunodeficiency Syndrome
HIV Infections
Interventions Drug: E/C/F/TDF
Drug: E/C/F/TAF Placebo
Drug: E/C/F/TAF
Drug: E/C/F/TDF Placebo
Enrollment 279
Recruitment Details Participants were enrolled at study sites in the United States and Puerto Rico. The first participant was screened on 28 December 2011. The last study visit occurred on 22 August 2016.
Pre-assignment Details 232 participants were screened for the Double-Blind Phase. 108 participants from other Gilead-sponsored Study GS-US-299-0102 joined the Open-Label Extension Phase.
Arm/Group Title E/C/F/TAF E/C/F/TDF D/C/F/TAF to Open-Label E/C/F/TAF DRV+COBI+TVD to Open-Label E/C/F/TAF
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Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily. Participants previously received darunavir (DRV) + cobicistat (COBI) + Truvada® (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
Period Title: Double-Blind Phase
Started 113 58 0 0
Completed 107 53 0 0
Not Completed 6 5 0 0
Reason Not Completed
Randomized but not Treated             1             0             0             0
Adverse Event             1             0             0             0
Lack of Efficacy             0             1             0             0
Investigator's Discretion             1             0             0             0
Withdrew Consent             0             1             0             0
Lost to Follow-up             3             2             0             0
Subject Non-Compliance             0             1             0             0
Period Title: Open-Label Extension Phase
Started 105 [1] 53 70 [2] 38 [2]
Completed 86 46 61 33
Not Completed 19 7 9 5
Reason Not Completed
Adverse Event             1             0             0             0
Death             1             0             0             0
Withdrew Consent             8             3             2             0
Pregnancy             0             1             1             0
Protocol Violation             0             0             1             0
Lost to Follow-up             9             3             5             5
[1]
2 participants completed the Double-Blind Phase, but did not continue in the Open-Label Extension.
[2]
Participants enrolled from other Gilead-sponsored Study GS-US-299-0102.
Arm/Group Title E/C/F/TAF E/C/F/TDF D/C/F/TAF to Open-Label E/C/F/TAF DRV+COBI+TVD to Open-Label E/C/F/TAF Total
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Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily. Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 112 58 70 38 278
Hide Baseline Analysis Population Description
E/C/F/TAF and E/C/F/TDF arms: participants who were randomized to the Double-Blind Phase and received at least 1 dose of study drug. D/C/F/TAF to E/C/F/TAF and DRV+COBI+TVD to E/C/F/TAF arms: participants who enrolled from Gilead-sponsored Study GS-US-299-0102 in the Open-Label Extension Phase and received at least 1 dose of open-label E/C/F/TAF
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 58 participants 70 participants 38 participants 278 participants
35  (11.3) 37  (10.6) 36  (11.2) 37  (10.7) 36  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 58 participants 70 participants 38 participants 278 participants
Female
4
   3.6%
1
   1.7%
3
   4.3%
3
   7.9%
11
   4.0%
Male
108
  96.4%
57
  98.3%
67
  95.7%
35
  92.1%
267
  96.0%
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 24
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Full Analysis Set: participants randomized to the Double-Blind Phase and received at least 1 dose of study drug.
Arm/Group Title E/C/F/TAF E/C/F/TDF
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Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Overall Number of Participants Analyzed 112 58
Measure Type: Number
Unit of Measure: percentage of participants
88.4 89.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF, E/C/F/TDF
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The null hypothesis was that the E/C/F/TAF group was at least 12% lower than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24. The alternative hypothesis was that the E/C/F/TAF group was less than 12% lower than the E/C/F/TDF group.
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-13.5 to 7.7
Estimation Comments Difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame Week 48
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Hide Analysis Population Description
Full Analysis Set
Arm/Group Title E/C/F/TAF E/C/F/TDF
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Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Overall Number of Participants Analyzed 112 58
Measure Type: Number
Unit of Measure: percentage of participants
88.4 87.9
3.Secondary Outcome
Title Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24 and 48
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Hide Analysis Population Description
Participants in Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:

Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Overall Number of Participants Analyzed 112 58
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
Baseline Number Analyzed 112 participants 58 participants
4.63  (0.572) 4.69  (0.577)
Change at Week 24 Number Analyzed 108 participants 58 participants
-3.20  (0.654) -3.26  (0.606)
Change at Week 48 Number Analyzed 107 participants 56 participants
-3.22  (0.606) -3.33  (0.572)
4.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Hide Description [Not Specified]
Time Frame Baseline; Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Full Analysis Set with available data were analyzed.
Arm/Group Title E/C/F/TAF E/C/F/TDF
Hide Arm/Group Description:

Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Overall Number of Participants Analyzed 112 58
Mean (Standard Deviation)
Unit of Measure: cells/uL
Baseline Number Analyzed 112 participants 58 participants
404  (181.6) 394  (209.6)
Change at Week 24 Number Analyzed 108 participants 58 participants
165  (115.6) 179  (127.7)
Change at Week 48 Number Analyzed 107 participants 56 participants
177  (144.1) 204  (120.4)
Time Frame Up to 186.2 weeks plus 30 days
Adverse Event Reporting Description
  • Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
  • Double-blind phase (E/C/F/TAF and E/C/F/TDF arms): adverse events were coded using the Medical Dictionary for Regulated Activities (MedDRA), version 17.0
  • All E/C/F/TAF arm: adverse events were coded using MedDRA, version 19.0
 
Arm/Group Title E/C/F/TAF E/C/F/TDF All E/C/F/TAF
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Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TAF.

Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks; Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TDF.

Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks; Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.

Participants received blinded or open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily

All-Cause Mortality
E/C/F/TAF E/C/F/TDF All E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
E/C/F/TAF E/C/F/TDF All E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/112 (10.71%)   3/58 (5.17%)   35/273 (12.82%) 
Cardiac disorders       
Acute myocardial infarction  1  1/112 (0.89%)  0/58 (0.00%)  2/273 (0.73%) 
Cardiac failure acute  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Coronary artery disease  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Myocardial infarction  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Pericarditis  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Gastrointestinal disorders       
Colitis  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Gastric ulcer haemorrhage  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Large intestine perforation  1  0/112 (0.00%)  1/58 (1.72%)  0/273 (0.00%) 
Pancreatitis  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Small intestinal obstruction  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
General disorders       
Non-cardiac chest pain  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Systemic inflammatory response syndrome  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/112 (0.00%)  0/58 (0.00%)  2/273 (0.73%) 
Infections and infestations       
Appendicitis  1  0/112 (0.00%)  0/58 (0.00%)  4/273 (1.47%) 
Cellulitis  1  0/112 (0.00%)  0/58 (0.00%)  2/273 (0.73%) 
Clostridium difficile colitis  1  0/112 (0.00%)  1/58 (1.72%)  0/273 (0.00%) 
Coxsackie viral infection  1  1/112 (0.89%)  0/58 (0.00%)  0/273 (0.00%) 
Cytomegalovirus colitis  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Erysipelas  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Furuncle  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Hepatitis C  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Infectious colitis  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Mycobacterium avium complex infection  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Neurosyphilis  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Perirectal abscess  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Pneumonia  1  1/112 (0.89%)  0/58 (0.00%)  2/273 (0.73%) 
Pyelonephritis  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Sinusitis  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Upper respiratory tract infection  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Viral infection  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Viral rash  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Concussion  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Contusion  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Facial bones fracture  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Femur fracture  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Pelvic fracture  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Rib fracture  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Road traffic accident  1  0/112 (0.00%)  1/58 (1.72%)  0/273 (0.00%) 
Subdural haematoma  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Thoracic vertebral fracture  1  0/112 (0.00%)  1/58 (1.72%)  0/273 (0.00%) 
Upper limb fracture  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Intervertebral disc protrusion  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Lumbar spinal stenosis  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Pain in extremity  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acute promyelocytic leukaemia  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Adenocarcinoma pancreas  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Malignant melanoma  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Nervous system disorders       
Vertebral artery dissection  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Pregnancy, puerperium and perinatal conditions       
Ectopic pregnancy  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Psychiatric disorders       
Bipolar disorder  1  1/112 (0.89%)  0/58 (0.00%)  3/273 (1.10%) 
Depression  1  1/112 (0.89%)  2/58 (3.45%)  3/273 (1.10%) 
Drug abuse  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Psychotic disorder  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Suicidal ideation  1  1/112 (0.89%)  2/58 (3.45%)  2/273 (0.73%) 
Renal and urinary disorders       
Acute kidney injury  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Respiratory, thoracic and mediastinal disorders       
Aspiration  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Dyspnoea  1  0/112 (0.00%)  0/58 (0.00%)  1/273 (0.37%) 
Pleural effusion  1  1/112 (0.89%)  0/58 (0.00%)  1/273 (0.37%) 
Pulmonary embolism  1  0/112 (0.00%)  1/58 (1.72%)  0/273 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0 and 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E/C/F/TAF E/C/F/TDF All E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   91/112 (81.25%)   48/58 (82.76%)   215/273 (78.75%) 
Endocrine disorders       
Hypogonadism  1  7/112 (6.25%)  0/58 (0.00%)  12/273 (4.40%) 
Gastrointestinal disorders       
Constipation  1  4/112 (3.57%)  3/58 (5.17%)  10/273 (3.66%) 
Diarrhoea  1  19/112 (16.96%)  9/58 (15.52%)  40/273 (14.65%) 
Dyspepsia  1  4/112 (3.57%)  3/58 (5.17%)  9/273 (3.30%) 
Flatulence  1  6/112 (5.36%)  2/58 (3.45%)  6/273 (2.20%) 
Nausea  1  25/112 (22.32%)  7/58 (12.07%)  35/273 (12.82%) 
Toothache  1  3/112 (2.68%)  1/58 (1.72%)  15/273 (5.49%) 
Vomiting  1  9/112 (8.04%)  4/58 (6.90%)  17/273 (6.23%) 
General disorders       
Fatigue  1  18/112 (16.07%)  5/58 (8.62%)  29/273 (10.62%) 
Immune system disorders       
Seasonal allergy  1  4/112 (3.57%)  3/58 (5.17%)  11/273 (4.03%) 
Infections and infestations       
Acarodermatitis  1  4/112 (3.57%)  3/58 (5.17%)  8/273 (2.93%) 
Bronchitis  1  7/112 (6.25%)  3/58 (5.17%)  33/273 (12.09%) 
Chlamydial infection  1  3/112 (2.68%)  2/58 (3.45%)  16/273 (5.86%) 
Conjunctivitis  1  9/112 (8.04%)  0/58 (0.00%)  18/273 (6.59%) 
Gastroenteritis  1  4/112 (3.57%)  2/58 (3.45%)  26/273 (9.52%) 
Influenza  1  8/112 (7.14%)  0/58 (0.00%)  19/273 (6.96%) 
Nasopharyngitis  1  7/112 (6.25%)  2/58 (3.45%)  31/273 (11.36%) 
Pharyngitis  1  10/112 (8.93%)  2/58 (3.45%)  20/273 (7.33%) 
Sinusitis  1  7/112 (6.25%)  3/58 (5.17%)  28/273 (10.26%) 
Syphilis  1  5/112 (4.46%)  3/58 (5.17%)  38/273 (13.92%) 
Upper respiratory tract infection  1  17/112 (15.18%)  12/58 (20.69%)  60/273 (21.98%) 
Injury, poisoning and procedural complications       
Procedural pain  1  3/112 (2.68%)  2/58 (3.45%)  14/273 (5.13%) 
Metabolism and nutrition disorders       
Hyperlipidaemia  1  3/112 (2.68%)  1/58 (1.72%)  19/273 (6.96%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  5/112 (4.46%)  2/58 (3.45%)  18/273 (6.59%) 
Back pain  1  3/112 (2.68%)  8/58 (13.79%)  27/273 (9.89%) 
Neck pain  1  3/112 (2.68%)  3/58 (5.17%)  4/273 (1.47%) 
Osteopenia  1  4/112 (3.57%)  2/58 (3.45%)  14/273 (5.13%) 
Pain in extremity  1  1/112 (0.89%)  3/58 (5.17%)  12/273 (4.40%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anorectal human papilloma virus infection  1  6/112 (5.36%)  4/58 (6.90%)  0/273 (0.00%) 
Skin papilloma  1  0/112 (0.00%)  3/58 (5.17%)  4/273 (1.47%) 
Nervous system disorders       
Headache  1  11/112 (9.82%)  8/58 (13.79%)  26/273 (9.52%) 
Paraesthesia  1  3/112 (2.68%)  4/58 (6.90%)  7/273 (2.56%) 
Psychiatric disorders       
Abnormal dreams  1  8/112 (7.14%)  1/58 (1.72%)  8/273 (2.93%) 
Anxiety  1  4/112 (3.57%)  5/58 (8.62%)  15/273 (5.49%) 
Depression  1  11/112 (9.82%)  2/58 (3.45%)  27/273 (9.89%) 
Insomnia  1  6/112 (5.36%)  4/58 (6.90%)  14/273 (5.13%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  11/112 (9.82%)  6/58 (10.34%)  36/273 (13.19%) 
Oropharyngeal pain  1  4/112 (3.57%)  1/58 (1.72%)  14/273 (5.13%) 
Skin and subcutaneous tissue disorders       
Rash  1  11/112 (9.82%)  3/58 (5.17%)  22/273 (8.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0 and 19.0
There were no limitations affecting the analysis or results.
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01497899    
Other Study ID Numbers: GS-US-292-0102
First Submitted: December 14, 2011
First Posted: December 23, 2011
Results First Submitted: December 4, 2015
Results First Posted: January 8, 2016
Last Update Posted: November 19, 2018