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Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

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ClinicalTrials.gov Identifier: NCT01968551
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : November 1, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV-1
HIV Infections
Acquired Immunodeficiency Syndrome
Interventions Drug: E/C/F/TAF
Drug: DRV
Drug: Baseline DRV- containing ARV regimen
Enrollment 158
Recruitment Details Participants were enrolled at study sites in the United States and Canada. The first participant was screened on 3 September 2013. The last study visit occurred on 09 July 2016.
Pre-assignment Details 231 participants were screened.
Arm/Group Title Cohort 1: E/C/F/TAF+DRV Cohort 2: E/C/F/TAF+DRV Cohort 2: Stay on Baseline Regimen (SBR)
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Open-Label (OL) Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Period Title: Open Label Phase (48 Weeks)
Started 22 90 46
Completed 20 87 41
Not Completed 2 3 5
Reason Not Completed
Randomized but Never Treated             1             1             0
Investigator’s Discretion             0             1             0
Withdrew Consent             1             1             3
Lost to Follow-up             0             0             2
Period Title: Extension Phase
Started 20 87 34 [1]
Completed 19 86 30
Not Completed 1 1 4
Reason Not Completed
Adverse Event             0             0             2
Death             0             1             0
Withdrew Consent             0             0             1
Lost to Follow-up             1             0             1
[1]
7 participant completed the Open-Label Phase, but did not enter in the Extension Phase
Arm/Group Title Cohort 1: E/C/F/TAF+DRV Cohort 2: E/C/F/TAF+DRV Cohort 2: SBR Total
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Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Total of all reporting groups
Overall Number of Baseline Participants 21 89 46 156
Hide Baseline Analysis Population Description
Safety analysis set included: Cohort 1: participants who (1) were enrolled into Cohort 1 and (2) received at least 1 dose of study drug during the OL Phase or the Extension Phase Cohort 2: participants who (1) were randomized into Cohort 2 and (2) received at least 1 dose of study drug during the OL Phase or the Extension Phase
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 89 participants 46 participants 156 participants
53  (5.7) 49  (8.2) 47  (9.4) 49  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 89 participants 46 participants 156 participants
Female
8
  38.1%
16
  18.0%
18
  39.1%
42
  26.9%
Male
13
  61.9%
73
  82.0%
28
  60.9%
114
  73.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 89 participants 46 participants 156 participants
American Indian or Alaska Native 0 1 0 1
Asian 0 1 0 1
Black 12 35 26 73
Native Hawaiian or Pacific Islander 0 1 0 1
White 9 51 17 77
Not Permitted 0 0 0 0
Other 0 0 3 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 89 participants 46 participants 156 participants
Hispanic or Latino 2 12 7 21
Not Hispanic or Latino 19 77 39 135
Not Permitted 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 89 participants 46 participants 156 participants
Canada 0 9 3 12
United States 21 80 43 144
HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 89 participants 46 participants 156 participants
< 50 copies/mL 19 87 46 152
≥ 50 copies/mL 2 2 0 4
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 21 participants 89 participants 46 participants 156 participants
700  (372.5) 562  (260.8) 571  (245.2) 583  (275.9)
CD4 Cell Count Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 89 participants 46 participants 156 participants
< 200 cells/µL 1 5 1 7
≥ 200 to < 350 cells/µL 3 15 7 25
≥ 350 cells/µL 17 69 38 124
1.Primary Outcome
Title Percentage of Participants in Each Treatment Arm in Cohort 2 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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Hide Analysis Population Description
Full Analysis Set (FAS) in Cohort 2, included all participants who (1) were randomized to Cohort 2 and (2) received at least 1 dose of study drug during the open-label Phase.
Arm/Group Title Cohort 2: E/C/F/TAF+DRV Cohort 2: Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:

Open-Label Phase: E/C/F/TDF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Overall Number of Participants Analyzed 89 46
Measure Type: Number
Unit of Measure: percentage of participants
96.6 91.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: E/C/F/TAF+DRV, Cohort 2: Stay on Baseline Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA<50 copies/mL at Week 24.
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportion
Estimated Value 5.3
Confidence Interval (2-Sided) 95.001%
-3.4 to 17.4
Estimation Comments Difference in percentages of virologic success and its 95.001% confidence interval (CI) calculation was based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with standardized statistic.
2.Secondary Outcome
Title Percentage of Participants in Each Treatment Arm in Cohort 2 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 included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study.
Arm/Group Title Cohort 2: E/C/F/TAF+DRV Cohort 2: Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Overall Number of Participants Analyzed 89 46
Measure Type: Number
Unit of Measure: percentage of participants
94.4 76.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 2: E/C/F/TAF+DRV, Cohort 2: Stay on Baseline Regimen (SBR)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48.
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportion
Estimated Value 18.3
Confidence Interval (2-Sided) 95.001%
3.5 to 33.0
Estimation Comments Difference in percentages of virologic success and its 95.001% CI were calculated based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.
3.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 (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.
Arm/Group Title Cohort 2: E/C/F/TAF+DRV Cohort 2: Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Overall Number of Participants Analyzed 88 42
Mean (Standard Deviation)
Unit of Measure: cells/μL
23  (155.2) 12  (100.9)
4.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 (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.
Arm/Group Title Cohort 2: E/C/F/TAF+DRV Cohort 2: Stay on Baseline Regimen (SBR)
Hide Arm/Group Description:

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800mg) tablet administered orally once daily for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.

Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Overall Number of Participants Analyzed 85 39
Mean (Standard Deviation)
Unit of Measure: cells/μL
5  (162.6) 41  (104.2)
Time Frame Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)
Adverse Event Reporting Description

Safety Analysis Set included all participants in:

  • Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase
  • Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase
  • All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase

For Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.

 
Arm/Group Title Cohort 1: E/C/F/TAF+DRV Cohort 2: E/C/F/TAF+DRV Cohort 2: SBR All E/C/F/TAF
Hide Arm/Group Description

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.

Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily

Open- label or Extension Phase: All participants received E/C/F/TAF.
All-Cause Mortality
Cohort 1: E/C/F/TAF+DRV Cohort 2: E/C/F/TAF+DRV Cohort 2: SBR All E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: E/C/F/TAF+DRV Cohort 2: E/C/F/TAF+DRV Cohort 2: SBR All E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/21 (4.76%)   9/89 (10.11%)   1/46 (2.17%)   20/144 (13.89%) 
Cardiac disorders         
Angina pectoris  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Angina unstable  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Coronary artery disease  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Myocardial infarction  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Tachycardia  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Gastrointestinal disorders         
Haemorrhoidal haemorrhage  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Pancreatitis  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Retroperitoneal haemorrhage  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Small intestinal obstruction  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  2/144 (1.39%) 
General disorders         
Chest pain  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  2/144 (1.39%) 
Death  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Non-cardiac chest pain  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Infections and infestations         
Bronchitis  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Cellulitis  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Clostridium difficile colitis  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Gastroenteritis  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Gastroenteritis clostridial  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Pneumonia bacterial  1  1/21 (4.76%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Sepsis  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Urinary tract infection  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Injury, poisoning and procedural complications         
Rib fracture  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Splenic rupture  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Subdural haematoma  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Vascular pseudoaneurysm  1  0/21 (0.00%)  0/89 (0.00%)  1/46 (2.17%)  0/144 (0.00%) 
Metabolism and nutrition disorders         
Obesity  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Diffuse large B-cell lymphoma  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Prostate cancer  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Nervous system disorders         
Syncope  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Psychiatric disorders         
Alcohol abuse  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Alcohol withdrawal syndrome  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Delirium  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Substance abuse  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/21 (0.00%)  1/89 (1.12%)  0/46 (0.00%)  1/144 (0.69%) 
Pneumothorax  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Vascular disorders         
Hypotension  1  0/21 (0.00%)  0/89 (0.00%)  0/46 (0.00%)  1/144 (0.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: E/C/F/TAF+DRV Cohort 2: E/C/F/TAF+DRV Cohort 2: SBR All E/C/F/TAF
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/21 (61.90%)   56/89 (62.92%)   28/46 (60.87%)   104/144 (72.22%) 
Gastrointestinal disorders         
Abdominal pain  1  0/21 (0.00%)  5/89 (5.62%)  2/46 (4.35%)  6/144 (4.17%) 
Constipation  1  0/21 (0.00%)  5/89 (5.62%)  0/46 (0.00%)  7/144 (4.86%) 
Diarrhoea  1  0/21 (0.00%)  4/89 (4.49%)  4/46 (8.70%)  10/144 (6.94%) 
Gastrooesophageal reflux disease  1  2/21 (9.52%)  2/89 (2.25%)  1/46 (2.17%)  7/144 (4.86%) 
Nausea  1  0/21 (0.00%)  5/89 (5.62%)  0/46 (0.00%)  8/144 (5.56%) 
Vomiting  1  0/21 (0.00%)  3/89 (3.37%)  2/46 (4.35%)  10/144 (6.94%) 
General disorders         
Fatigue  1  0/21 (0.00%)  4/89 (4.49%)  2/46 (4.35%)  8/144 (5.56%) 
Infections and infestations         
Acute sinusitis  1  4/21 (19.05%)  1/89 (1.12%)  0/46 (0.00%)  9/144 (6.25%) 
Bronchitis  1  3/21 (14.29%)  6/89 (6.74%)  1/46 (2.17%)  14/144 (9.72%) 
Influenza  1  0/21 (0.00%)  1/89 (1.12%)  3/46 (6.52%)  3/144 (2.08%) 
Nasopharyngitis  1  0/21 (0.00%)  6/89 (6.74%)  2/46 (4.35%)  8/144 (5.56%) 
Oral candidiasis  1  2/21 (9.52%)  1/89 (1.12%)  0/46 (0.00%)  3/144 (2.08%) 
Otitis media  1  2/21 (9.52%)  3/89 (3.37%)  0/46 (0.00%)  7/144 (4.86%) 
Pharyngitis  1  0/21 (0.00%)  5/89 (5.62%)  1/46 (2.17%)  7/144 (4.86%) 
Sinusitis  1  3/21 (14.29%)  6/89 (6.74%)  4/46 (8.70%)  15/144 (10.42%) 
Upper respiratory tract infection  1  3/21 (14.29%)  10/89 (11.24%)  2/46 (4.35%)  27/144 (18.75%) 
Viral upper respiratory tract infection  1  1/21 (4.76%)  4/89 (4.49%)  2/46 (4.35%)  8/144 (5.56%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/21 (9.52%)  3/89 (3.37%)  2/46 (4.35%)  7/144 (4.86%) 
Back pain  1  0/21 (0.00%)  11/89 (12.36%)  3/46 (6.52%)  12/144 (8.33%) 
Musculoskeletal pain  1  1/21 (4.76%)  2/89 (2.25%)  3/46 (6.52%)  6/144 (4.17%) 
Myalgia  1  1/21 (4.76%)  5/89 (5.62%)  1/46 (2.17%)  8/144 (5.56%) 
Pain in extremity  1  0/21 (0.00%)  4/89 (4.49%)  4/46 (8.70%)  7/144 (4.86%) 
Nervous system disorders         
Headache  1  1/21 (4.76%)  6/89 (6.74%)  0/46 (0.00%)  16/144 (11.11%) 
Hypoaesthesia  1  2/21 (9.52%)  1/89 (1.12%)  0/46 (0.00%)  4/144 (2.78%) 
Psychiatric disorders         
Depression  1  2/21 (9.52%)  2/89 (2.25%)  0/46 (0.00%)  8/144 (5.56%) 
Insomnia  1  0/21 (0.00%)  4/89 (4.49%)  1/46 (2.17%)  9/144 (6.25%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/21 (4.76%)  4/89 (4.49%)  3/46 (6.52%)  10/144 (6.94%) 
Vascular disorders         
Hypertension  1  0/21 (0.00%)  4/89 (4.49%)  0/46 (0.00%)  8/144 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 19.0
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: Clinical Trial Disclosures
Organization: Gilead Sciences
Publications:
Greg Huhn, Pablo Tebas, Joel Gallant et al. Strategic Simplification: the Efficacy and Safety of Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Plus Darunavir (DRV) in Treatment-Experienced HIV-1‒Infected Adults (NCT01968551). IDWeek; 2015 San Diego, CA Oct. 7-11.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01968551     History of Changes
Other Study ID Numbers: GS-US-292-0119
First Submitted: September 26, 2013
First Posted: October 24, 2013
Results First Submitted: July 20, 2016
Results First Posted: November 1, 2016
Last Update Posted: November 16, 2018