Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive 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: NCT01095796

Recruitment Status : Completed

First Posted : March 30, 2010

Results First Posted : October 22, 2012

Last Update Posted : November 11, 2015

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	HIV HIV Infections
Interventions	Drug: Stribild Drug: Atripla Drug: Stribild Placebo Drug: Atripla Placebo
Enrollment	707

Participant Flow

Recruitment Details	Participants were enrolled at sites in the United States and Puerto Rico. The first participant was screened on 16 March 2010. The last study visit occurred on 02 September 2014.
Pre-assignment Details	917 participants were screened.


Arm/Group Title	Stribild	Atripla
Arm/Group Description	Stribild® (elvitegravir (EVG) 150 m...	Atripla® (efavirenz (EFV) 600 mg/FT...
Arm/Group Description	Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regimen (STR) once daily plus placebo to match Atripla once daily prior to bedtime	Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Period Title: Overall Study
Started	353	354
Completed	58	65
Not Completed	295	289
Reason Not Completed
Randomized but Not Treated	5	2
Adverse Event	9	19
Death	3	2
Pregnancy	2	0
Lack of Efficacy	5	3
Investigator's Discretion	7	2
Withdrew Consent	16	22
Lost to Follow-up	27	29
Participant Noncompliance	5	10
Protocol Violation	1	0
Participant Transferred to Another Study	215	200

Baseline Characteristics

Arm/Group Title		Stribild	Atripla	Total
Arm/Group Description		Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...	Total of all reporting groups
Arm/Group Description		Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily	Total of all reporting groups
Overall Number of Baseline Participants		348	352	700
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	348 participants	352 participants	700 participants
		38 (10.4)	38 (10.6)	38 (10.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	348 participants	352 participants	700 participants
	Female	41 11.8%	36 10.2%	77 11.0%
	Male	307 88.2%	316 89.8%	623 89.0%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	348 participants	352 participants	700 participants
American Indian or Alaska Native		2	4	6
Asian		6	10	16
Black or African Heritage		106	91	197
Native Hawaiian or Pacific Islander		4	1	5
White		214	227	441
Other		16	19	35
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	348 participants	352 participants	700 participants
United States		348	352	700
HIV Disease Status Measure Type: Number Unit of measure: Participants	Number Analyzed	348 participants	352 participants	700 participants
Asymptomatic		290	295	585
Symptomatic HIV Infections		30	33	63
AIDS		28	24	52
Hepatitis B Virus (HBV) Infection Status Measure Type: Number Unit of measure: Participants	Number Analyzed	348 participants	352 participants	700 participants
Negative		343	343	686
Positive		5	9	14
Hepatitis C Virus (HCV) Infection Status Measure Type: Number Unit of measure: Participants	Number Analyzed	348 participants	352 participants	700 participants
Negative		331	337	668
Positive		17	15	32
HIV-1 RNA Category (copies/mL) Measure Type: Number Unit of measure: Participants	Number Analyzed	348 participants	352 participants	700 participants
≤ 100,000		230	236	466
> 100,000		118	116	234
CD4 Cell Count (/µL) Measure Type: Number Unit of measure: Participants	Number Analyzed	348 participants	352 participants	700 participants
≤ 50		7	6	13
51 to ≤ 200		36	45	81
201 to ≤ 350		112	96	208
351 to ≤ 500		113	136	249
> 500		80	69	149

Outcome Measures

1.Primary Outcome


Title	The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug


Arm/Group Title	Stribild	Atripla
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	348	352
Measure Type: Number Unit of Measure: percentage of participants
	87.6	84.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stribild, Atripla
	Comments	The null hypothesis was that the percentage of participants achieving HIV-1 RNA < 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla Group.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA < 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.

Method of Estimation	Estimation Parameter	Difference in response rates
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95.2% -1.6 to 8.8
	Estimation Comments	To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL).

2.Secondary Outcome


Title	The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug


Arm/Group Title	Stribild	Atripla
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	348	352
Measure Type: Number Unit of Measure: percentage of participants
	84.2	81.5

3.Secondary Outcome


Title	The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Week 144

Outcome Measure Data

Analysis Population Description

ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug


Arm/Group Title	Stribild	Atripla
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	348	352
Measure Type: Number Unit of Measure: percentage of participants
	80.2	75.3

4.Secondary Outcome


Title	The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Week 192

Outcome Measure Data

Analysis Population Description

Week 192 Modified Intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.


Arm/Group Title	Stribild	Atripla
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	71	73
Measure Type: Number Unit of Measure: percentage of participants
	76.1	78.1

5.Secondary Outcome


Title	The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT Analysis Set


Arm/Group Title	Stribild	Atripla
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	348	352
Measure Type: Number Unit of Measure: percentage of participants
	85.9	83.2

6.Secondary Outcome


Title	The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
Description	Change = value of the relevant time point minus the baseline value
Description	Change = value of the relevant time point minus the baseline value
Time Frame	Baseline; Weeks 48, 96, 144, and 192

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. The missing = excluded (M = E) method was used in which all participants with missing data were excluded from analysis.


Arm/Group Title	Stribild	Atripla
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	348	352
Mean (Standard Deviation) Unit of Measure: cells/µL
Change at Wk 48 (Stribild, n=325; Atripla, n=315)	239 (167.2)	206 (153.4)
Change at Wk 96 (Stribild, n=307; Atripla, n=302)	295 (213.3)	273 (189.7)
Change at Wk 144 (Stribild, n=294; Atripla, n=283)	321 (227.0)	300 (202.3)
Change at Wk 192 (Stribild, n=62; Atripla, n=69)	360 (285.9)	328 (227.6)

7.Secondary Outcome


Title	The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT Analysis Set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).


Arm/Group Title	Stribild	Atripla
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	348	352
Measure Type: Number Unit of Measure: percentage of participants
	88.8	85.5

Adverse Events

Time Frame	Up to 218 weeks plus 30 days
Adverse Event Reporting Description	Safety Analysis Set: participants were randomized and received at least one dose of study drug.

Arm/Group Title	Stribild	Atripla
Arm/Group Description	Stribild (EVG 150 mg/COBI 150 mg/FT...	Atripla (EFV 600 mg/FTC 200 mg/TDF ...
Arm/Group Description	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime	Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
All-Cause Mortality
	Stribild	Atripla
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Stribild	Atripla
	Affected / at Risk (%)	Affected / at Risk (%)
Total	69/348 (19.83%)	50/352 (14.20%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/348 (0.00%)	1/352 (0.28%)
Antiphospholipid syndrome ^† 1	0/348 (0.00%)	1/352 (0.28%)
Splenic vein thrombosis ^† 1	0/348 (0.00%)	1/352 (0.28%)
Thrombocytopenia ^† 1	0/348 (0.00%)	1/352 (0.28%)
Cardiac disorders
Acute myocardial infarction ^† 1	0/348 (0.00%)	1/352 (0.28%)
Bradycardia ^† 1	0/348 (0.00%)	1/352 (0.28%)
Intracardiac mass ^† 1	0/348 (0.00%)	1/352 (0.28%)
Palpitations ^† 1	0/348 (0.00%)	1/352 (0.28%)
Supraventricular tachycardia ^† 1	0/348 (0.00%)	1/352 (0.28%)
Tachycardia ^† 1	0/348 (0.00%)	1/352 (0.28%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/348 (0.29%)	2/352 (0.57%)
Colitis ^† 1	2/348 (0.57%)	0/352 (0.00%)
Diarrhoea ^† 1	1/348 (0.29%)	0/352 (0.00%)
Gastritis ^† 1	1/348 (0.29%)	0/352 (0.00%)
Haematemesis ^† 1	1/348 (0.29%)	0/352 (0.00%)
Inflammatory bowel disease ^† 1	0/348 (0.00%)	1/352 (0.28%)
Inguinal hernia ^† 1	1/348 (0.29%)	0/352 (0.00%)
Intestinal mass ^† 1	1/348 (0.29%)	0/352 (0.00%)
Intestinal perforation ^† 1	1/348 (0.29%)	1/352 (0.28%)
Mesenteric vein thrombosis ^† 1	0/348 (0.00%)	1/352 (0.28%)
Pancreatitis ^† 1	1/348 (0.29%)	0/352 (0.00%)
Pancreatitis acute ^† 1	0/348 (0.00%)	1/352 (0.28%)
Proctalgia ^† 1	2/348 (0.57%)	0/352 (0.00%)
Umbilical hernia ^† 1	1/348 (0.29%)	0/352 (0.00%)
Upper gastrointestinal haemorrhage ^† 1	1/348 (0.29%)	0/352 (0.00%)
Vomiting ^† 1	1/348 (0.29%)	0/352 (0.00%)
General disorders
Asthenia ^† 1	0/348 (0.00%)	1/352 (0.28%)
Chest pain ^† 1	1/348 (0.29%)	1/352 (0.28%)
Fatigue ^† 1	2/348 (0.57%)	0/352 (0.00%)
Non-cardiac chest pain ^† 1	1/348 (0.29%)	0/352 (0.00%)
Pyrexia ^† 1	1/348 (0.29%)	2/352 (0.57%)
Systemic inflammatory response syndrome ^† 1	1/348 (0.29%)	0/352 (0.00%)
Hepatobiliary disorders
Cholecystitis ^† 1	1/348 (0.29%)	1/352 (0.28%)
Cholelithiasis ^† 1	2/348 (0.57%)	0/352 (0.00%)
Hepatitis alcoholic ^† 1	1/348 (0.29%)	0/352 (0.00%)
Liver injury ^† 1	1/348 (0.29%)	0/352 (0.00%)
Immune system disorders
Anaphylactic reaction ^† 1	0/348 (0.00%)	1/352 (0.28%)
Infections and infestations
Abscess limb ^† 1	1/348 (0.29%)	0/352 (0.00%)
Acute sinusitis ^† 1	0/348 (0.00%)	1/352 (0.28%)
Appendicitis ^† 1	4/348 (1.15%)	3/352 (0.85%)
Bronchitis ^† 1	1/348 (0.29%)	3/352 (0.85%)
Bronchitis bacterial ^† 1	1/348 (0.29%)	0/352 (0.00%)
Cellulitis ^† 1	6/348 (1.72%)	0/352 (0.00%)
Cellulitis staphylococcal ^† 1	1/348 (0.29%)	0/352 (0.00%)
Diarrhoea infectious ^† 1	0/348 (0.00%)	1/352 (0.28%)
Diverticulitis ^† 1	1/348 (0.29%)	1/352 (0.28%)
Gastroenteritis ^† 1	2/348 (0.57%)	1/352 (0.28%)
Giardiasis ^† 1	0/348 (0.00%)	1/352 (0.28%)
H1N1 influenza ^† 1	1/348 (0.29%)	0/352 (0.00%)
Herpes simplex ^† 1	1/348 (0.29%)	0/352 (0.00%)
Incision site infection ^† 1	1/348 (0.29%)	0/352 (0.00%)
Meningitis viral ^† 1	1/348 (0.29%)	0/352 (0.00%)
Muscle abscess ^† 1	1/348 (0.29%)	0/352 (0.00%)
Neurosyphilis ^† 1	1/348 (0.29%)	2/352 (0.57%)
Ovarian abscess ^† 1	1/348 (0.29%)	0/352 (0.00%)
Pelvic inflammatory disease ^† 1	1/348 (0.29%)	0/352 (0.00%)
Pneumonia ^† 1	9/348 (2.59%)	2/352 (0.57%)
Pneumonia legionella ^† 1	1/348 (0.29%)	0/352 (0.00%)
Pulmonary tuberculosis ^† 1	1/348 (0.29%)	0/352 (0.00%)
Pyelonephritis acute ^† 1	0/348 (0.00%)	1/352 (0.28%)
Rectal abscess ^† 1	1/348 (0.29%)	0/352 (0.00%)
Secondary syphilis ^† 1	1/348 (0.29%)	0/352 (0.00%)
Sepsis ^† 1	0/348 (0.00%)	1/352 (0.28%)
Sepsis syndrome ^† 1	0/348 (0.00%)	1/352 (0.28%)
Skin bacterial infection ^† 1	0/348 (0.00%)	1/352 (0.28%)
Subcutaneous abscess ^† 1	1/348 (0.29%)	0/352 (0.00%)
Urinary tract infection ^† 1	0/348 (0.00%)	1/352 (0.28%)
Viral infection ^† 1	3/348 (0.86%)	0/352 (0.00%)
Injury, poisoning and procedural complications
Ankle fracture ^† 1	1/348 (0.29%)	0/352 (0.00%)
Cervical vertebral fracture ^† 1	0/348 (0.00%)	1/352 (0.28%)
Facial bones fracture ^† 1	1/348 (0.29%)	0/352 (0.00%)
Femur fracture ^† 1	1/348 (0.29%)	0/352 (0.00%)
Fibula fracture ^† 1	1/348 (0.29%)	0/352 (0.00%)
Gun shot wound ^† 1	1/348 (0.29%)	0/352 (0.00%)
Head injury ^† 1	0/348 (0.00%)	1/352 (0.28%)
Humerus fracture ^† 1	1/348 (0.29%)	0/352 (0.00%)
Intentional overdose ^† 1	1/348 (0.29%)	0/352 (0.00%)
Joint dislocation ^† 1	1/348 (0.29%)	0/352 (0.00%)
Limb injury ^† 1	0/348 (0.00%)	1/352 (0.28%)
Lumbar vertebral fracture ^† 1	1/348 (0.29%)	0/352 (0.00%)
Post procedural haemorrhage ^† 1	1/348 (0.29%)	0/352 (0.00%)
Subdural haematoma ^† 1	1/348 (0.29%)	0/352 (0.00%)
Tibia fracture ^† 1	1/348 (0.29%)	0/352 (0.00%)
Investigations
Alanine aminotransferase increased ^† 1	1/348 (0.29%)	0/352 (0.00%)
Aspartate aminotransferase increased ^† 1	1/348 (0.29%)	0/352 (0.00%)
Transaminases increased ^† 1	1/348 (0.29%)	0/352 (0.00%)
Metabolism and nutrition disorders
Dehydration ^† 1	0/348 (0.00%)	2/352 (0.57%)
Diabetic ketoacidosis ^† 1	0/348 (0.00%)	1/352 (0.28%)
Musculoskeletal and connective tissue disorders
Arthritis ^† 1	0/348 (0.00%)	1/352 (0.28%)
Back pain ^† 1	0/348 (0.00%)	1/352 (0.28%)
Intervertebral disc protrusion ^† 1	1/348 (0.29%)	0/352 (0.00%)
Synovitis ^† 1	1/348 (0.29%)	0/352 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma ^† 1	0/348 (0.00%)	1/352 (0.28%)
Anal cancer ^† 1	0/348 (0.00%)	1/352 (0.28%)
Anal cancer recurrent ^† 1	0/348 (0.00%)	1/352 (0.28%)
Anorectal human papilloma virus infection ^† 1	1/348 (0.29%)	0/352 (0.00%)
Bladder cancer recurrent ^† 1	1/348 (0.29%)	0/352 (0.00%)
Burkitt's lymphoma ^† 1	1/348 (0.29%)	0/352 (0.00%)
Colorectal cancer stage IV ^† 1	0/348 (0.00%)	1/352 (0.28%)
Diffuse large B-cell lymphoma ^† 1	0/348 (0.00%)	1/352 (0.28%)
Hodgkin's disease ^† 1	1/348 (0.29%)	0/352 (0.00%)
Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma ^† 1	0/348 (0.00%)	1/352 (0.28%)
Kaposi's sarcoma ^† 1	1/348 (0.29%)	0/352 (0.00%)
Lymphoma ^† 1	1/348 (0.29%)	0/352 (0.00%)
Malignant melanoma ^† 1	0/348 (0.00%)	1/352 (0.28%)
Metastatic neoplasm ^† 1	0/348 (0.00%)	1/352 (0.28%)
Uterine leiomyoma ^† 1	2/348 (0.57%)	1/352 (0.28%)
Nervous system disorders
Convulsion ^† 1	0/348 (0.00%)	1/352 (0.28%)
Grand mal convulsion ^† 1	0/348 (0.00%)	1/352 (0.28%)
Headache ^† 1	1/348 (0.29%)	1/352 (0.28%)
Hepatic encephalopathy ^† 1	1/348 (0.29%)	0/352 (0.00%)
Migraine ^† 1	1/348 (0.29%)	1/352 (0.28%)
Presyncope ^† 1	0/348 (0.00%)	1/352 (0.28%)
Syncope ^† 1	1/348 (0.29%)	2/352 (0.57%)
Psychiatric disorders
Alcoholism ^† 1	1/348 (0.29%)	0/352 (0.00%)
Bipolar disorder ^† 1	1/348 (0.29%)	1/352 (0.28%)
Completed suicide ^† 1	1/348 (0.29%)	2/352 (0.57%)
Depression ^† 1	2/348 (0.57%)	1/352 (0.28%)
Depression suicidal ^† 1	1/348 (0.29%)	0/352 (0.00%)
Drug dependence ^† 1	0/348 (0.00%)	1/352 (0.28%)
Major depression ^† 1	0/348 (0.00%)	1/352 (0.28%)
Psychotic disorder ^† 1	0/348 (0.00%)	1/352 (0.28%)
Suicidal behaviour ^† 1	1/348 (0.29%)	0/352 (0.00%)
Suicidal ideation ^† 1	1/348 (0.29%)	0/352 (0.00%)
Suicide attempt ^† 1	1/348 (0.29%)	2/352 (0.57%)
Renal and urinary disorders
Nephrolithiasis ^† 1	0/348 (0.00%)	2/352 (0.57%)
Renal failure ^† 1	1/348 (0.29%)	0/352 (0.00%)
Renal failure acute ^† 1	0/348 (0.00%)	1/352 (0.28%)
Reproductive system and breast disorders
Pelvic pain ^† 1	0/348 (0.00%)	1/352 (0.28%)
Testicular mass ^† 1	1/348 (0.29%)	0/352 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthma ^† 1	3/348 (0.86%)	1/352 (0.28%)
Chronic obstructive pulmonary disease ^† 1	1/348 (0.29%)	0/352 (0.00%)
Dyspnoea ^† 1	0/348 (0.00%)	2/352 (0.57%)
Dyspnoea exertional ^† 1	0/348 (0.00%)	1/352 (0.28%)
Pleural effusion ^† 1	0/348 (0.00%)	1/352 (0.28%)
Pneumomediastinum ^† 1	0/348 (0.00%)	1/352 (0.28%)
Pulmonary embolism ^† 1	0/348 (0.00%)	1/352 (0.28%)
Pulmonary thrombosis ^† 1	1/348 (0.29%)	0/352 (0.00%)
Respiratory failure ^† 1	1/348 (0.29%)	0/352 (0.00%)
Skin and subcutaneous tissue disorders
Rash maculo-papular ^† 1	0/348 (0.00%)	1/352 (0.28%)
Social circumstances
Alcohol use ^† 1	1/348 (0.29%)	0/352 (0.00%)
Vascular disorders
Deep vein thrombosis ^† 1	2/348 (0.57%)	0/352 (0.00%)
Haematoma ^† 1	0/348 (0.00%)	1/352 (0.28%)
Hypertension ^† 1	2/348 (0.57%)	0/352 (0.00%)
Hypertensive crisis ^† 1	1/348 (0.29%)	0/352 (0.00%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 17.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Stribild	Atripla
	Affected / at Risk (%)	Affected / at Risk (%)
Total	313/348 (89.94%)	326/352 (92.61%)
Blood and lymphatic system disorders
Lymphadenopathy ^† 1	16/348 (4.60%)	18/352 (5.11%)
Gastrointestinal disorders
Abdominal pain ^† 1	24/348 (6.90%)	18/352 (5.11%)
Constipation ^† 1	22/348 (6.32%)	14/352 (3.98%)
Diarrhoea ^† 1	93/348 (26.72%)	91/352 (25.85%)
Dyspepsia ^† 1	19/348 (5.46%)	10/352 (2.84%)
Gastrooesophageal reflux disease ^† 1	19/348 (5.46%)	14/352 (3.98%)
Haemorrhoids ^† 1	23/348 (6.61%)	13/352 (3.69%)
Nausea ^† 1	80/348 (22.99%)	59/352 (16.76%)
Vomiting ^† 1	28/348 (8.05%)	23/352 (6.53%)
General disorders
Fatigue ^† 1	53/348 (15.23%)	61/352 (17.33%)
Pyrexia ^† 1	21/348 (6.03%)	23/352 (6.53%)
Infections and infestations
Bronchitis ^† 1	41/348 (11.78%)	37/352 (10.51%)
Chlamydial infection ^† 1	23/348 (6.61%)	13/352 (3.69%)
Folliculitis ^† 1	17/348 (4.89%)	18/352 (5.11%)
Gonorrhoea ^† 1	22/348 (6.32%)	9/352 (2.56%)
Herpes zoster ^† 1	19/348 (5.46%)	9/352 (2.56%)
Influenza ^† 1	15/348 (4.31%)	19/352 (5.40%)
Nasopharyngitis ^† 1	38/348 (10.92%)	34/352 (9.66%)
Pharyngitis ^† 1	16/348 (4.60%)	22/352 (6.25%)
Sinusitis ^† 1	41/348 (11.78%)	46/352 (13.07%)
Syphilis ^† 1	34/348 (9.77%)	33/352 (9.38%)
Upper respiratory tract infection ^† 1	92/348 (26.44%)	78/352 (22.16%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	18/348 (5.17%)	15/352 (4.26%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	33/348 (9.48%)	22/352 (6.25%)
Back pain ^† 1	38/348 (10.92%)	26/352 (7.39%)
Pain in extremity ^† 1	21/348 (6.03%)	24/352 (6.82%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anorectal human papilloma virus infection ^† 1	20/348 (5.75%)	13/352 (3.69%)
Nervous system disorders
Dizziness ^† 1	29/348 (8.33%)	94/352 (26.70%)
Headache ^† 1	62/348 (17.82%)	45/352 (12.78%)
Somnolence ^† 1	7/348 (2.01%)	28/352 (7.95%)
Psychiatric disorders
Abnormal dreams ^† 1	56/348 (16.09%)	101/352 (28.69%)
Anxiety ^† 1	30/348 (8.62%)	33/352 (9.38%)
Depression ^† 1	56/348 (16.09%)	59/352 (16.76%)
Insomnia ^† 1	47/348 (13.51%)	63/352 (17.90%)
Reproductive system and breast disorders
Erectile dysfunction ^† 1	13/348 (3.74%)	21/352 (5.97%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	39/348 (11.21%)	26/352 (7.39%)
Oropharyngeal pain ^† 1	23/348 (6.61%)	32/352 (9.09%)
Sinus congestion ^† 1	22/348 (6.32%)	14/352 (3.98%)
Skin and subcutaneous tissue disorders
Dermatitis ^† 1	16/348 (4.60%)	20/352 (5.68%)
Rash ^† 1	35/348 (10.06%)	53/352 (15.06%)
Vascular disorders
Hypertension ^† 1	21/348 (6.03%)	22/352 (6.25%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 17.0

Limitations and Caveats

There were no limitations affecting the analysis or results.

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.

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, Inc.
EMail:	ClinicalTrialDisclosures@gilead.com

Publications of Results:

Sax PE, DeJesus E, Mills A, Zolopa A, Cohen C, Wohl D, Gallant JE, Liu HC, Zhong L, Yale K, White K, Kearney BP, Szwarcberg J, Quirk E, Cheng AK; GS-US-236-0102 study team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012 Jun 30;379(9835):2439-2448. doi: 10.1016/S0140-6736(12)60917-9. Erratum in: Lancet. 2012 Aug 25;380(9843):730.

Zolopa A, Sax PE, DeJesus E, Mills A, Cohen C, Wohl D, Gallant JE, Liu HC, Plummer A, White KL, Cheng AK, Rhee MS, Szwarcberg J; GS-US-236-0102 Study Team. A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 May 1;63(1):96-100. doi: 10.1097/QAI.0b013e318289545c.

Wohl DA, Cohen C, Gallant JE, Mills A, Sax PE, Dejesus E, Zolopa A, Liu HC, Plummer A, White KL, Cheng AK, Rhee MS, Szwarcberg J; GS-US-236-0102 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF versus single-tablet regimen efavirenz/emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):e118-20. doi: 10.1097/QAI.0000000000000057.

Layout table for additonal information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01095796
Other Study ID Numbers:	GS-US-236-0102
First Submitted:	March 17, 2010
First Posted:	March 30, 2010
Results First Submitted:	September 20, 2012
Results First Posted:	October 22, 2012
Last Update Posted:	November 11, 2015

To Top