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

Participant Flow

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)
Arm/Group Description	Open-Label (OL) Phase: Elvitegravir...	Open-Label Phase: E/C/F/TAF (150/15...	Open-Label Phase: Participants stay...
Arm/Group Description	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

Baseline Characteristics

Arm/Group Title		Cohort 1: E/C/F/TAF+DRV	Cohort 2: E/C/F/TAF+DRV	Cohort 2: SBR	Total
Arm/Group Description		Open-Label Phase: E/C/F/TAF (150/15...	Open-Label Phase: E/C/F/TAF (150/15...	Open-Label Phase: Participants stay...	Total of all reporting groups
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	Total of all reporting groups
Overall Number of Baseline Participants		21	89	46	156
Baseline Analysis Population Description		...
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

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24
Description	The percentage of participants achieving HIV-1 RNA < 50 copies/mL a...
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

Outcome Measure Data

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)
Arm/Group Description:	Open-Label Phase: E/C/F/TDF (150/15...	Open-Label Phase: Participants stay...
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

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
Description	The percentage of participants achieving HIV-1 RNA < 50 copies/mL a...
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

Outcome Measure Data

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)
Arm/Group Description:	Open-Label Phase: E/C/F/TAF (150/15...	Open-Label Phase: Participants stay...
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

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 24

Outcome Measure Data

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)
Arm/Group Description:	Open-Label Phase: E/C/F/TAF (150/15...	Open-Label Phase: Participants stay...
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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 48

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Cohort 2: E/C/F/TAF+DRV	Cohort 2: Stay on Baseline Regimen (SBR)
Arm/Group Description:	Open-Label Phase: E/C/F/TAF (150/15...	Open-Label Phase: Participants stay...
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)

Adverse Events

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
Arm/Group Description	Open-Label Phase: E/C/F/TAF (150/15...	Open-Label Phase: E/C/F/TAF (150/15...	Open-Label Phase: Participants stay...	Open- label or Extension Phase: All...
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	--/--	--/--	--/--	--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

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Name/Title:	Clinical Trial Disclosures
Organization:	Gilead Sciences
EMail:	ClinicalTrialDisclosures@gilead.com

Publications:

Huhn GD, Tebas P, Gallant J, Wilkin T, Cheng A, Yan M, Zhong L, Callebaut C, Custodio JM, Fordyce MW, Das M, McCallister S. A Randomized, Open-Label Trial to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Darunavir in Treatment-Experienced HIV-1-Infected Adults. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):193-200. doi: 10.1097/QAI.0000000000001193.

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.

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Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01968551
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

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