Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT01106586

Recruitment Status : Completed

First Posted : April 20, 2010

Results First Posted : October 22, 2012

Last Update Posted : November 11, 2015

View this study on Beta.ClinicalTrials.gov

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: ATV Drug: Ritonavir Drug: FTC/TDF Drug: Stribild Placebo Drug: ATV Placebo Drug: RTV Placebo Drug: FTC/TDF Placebo
Enrollment	708

Participant Flow

Recruitment Details	Participants were enrolled at 146 sites in 16 countries. The first participant was screened on 06 April 2010. The last study visit occurred on 18 September 2014.
Pre-assignment Details	1017 subjects were screened.


Arm/Group Title	Stribild	ATV/r + FTC/TDF
Arm/Group Description	Stribild® (elvitegravir (EVG) 150 m...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description	Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Period Title: Overall Study
Started	353	355
Completed	68	70
Not Completed	285	285
Reason Not Completed
Adverse Event	9	15
Death	1	3
Pregnancy	2	2
Lack of Efficacy	1	0
Investigator's Discretion	5	8
Withdrew Consent	18	30
Lost to Follow-up	24	20
Participant Noncompliance	12	10
Protocol Violation	1	0
Participant Transferred to Another Study	212	197

Baseline Characteristics

Arm/Group Title		Stribild	ATV/r + FTC/TDF	Total
Arm/Group Description		Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...	Total of all reporting groups
Arm/Group Description		Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily	Total of all reporting groups
Overall Number of Baseline Participants		353	355	708
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	353 participants	355 participants	708 participants
		38 (10.5)	39 (9.8)	38 (10.2)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	353 participants	355 participants	708 participants
	Female	29 8.2%	39 11.0%	68 9.6%
	Male	324 91.8%	316 89.0%	640 90.4%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	353 participants	355 participants	708 participants
American Indian or Alaska Native		2	3	5
Asian		17	17	34
Black or African Heritage		72	47	119
Native Hawaiian or Pacific Islander		1	2	3
White		250	277	527
Other		11	9	20
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	353 participants	355 participants	708 participants
Portugal		1	2	3
United States		197	185	382
Thailand		7	4	11
Austria		12	8	20
United Kingdom		11	15	26
Switzerland		0	2	2
Italy		9	5	14
France		23	23	46
Mexico		3	2	5
Canada		19	22	41
Belgium		9	12	21
Australia		30	32	62
Denmark		1	2	3
Netherlands		2	4	6
Germany		29	36	65
Sweden		0	1	1
HIV Disease Status Measure Type: Number Unit of measure: Participants	Number Analyzed	353 participants	355 participants	708 participants
Asymptomatic		285	293	578
Symptomatic HIV Infections		36	38	74
AIDS		32	24	56
Hepatitis B Virus (HBV) Infection Status Measure Type: Number Unit of measure: Participants	Number Analyzed	353 participants	355 participants	708 participants
Negative		347	346	693
Positive		5	7	12
Indeterminate		0	1	1
Not done		1	1	2
Hepatitis C Virus (HCV) Infection Status Measure Type: Number Unit of measure: Participants	Number Analyzed	353 participants	355 participants	708 participants
Negative		335	344	679
Positive		18	10	28
Indeterminate		0	0	0
Not done		0	1	1
HIV-1 RNA Category (copies/mL) Measure Type: Number Unit of measure: Participants	Number Analyzed	353 participants	355 participants	708 participants
≤ 100,000 copies/mL		203	214	417
> 100,000 copies/mL		150	141	291
CD4 Cell Count (/µL) Measure Type: Number Unit of measure: Participants	Number Analyzed	353 participants	355 participants	708 participants
≤ 50 μL		12	5	17
51 to ≤ 200 μL		42	34	76
201 to ≤ 350 μL		122	124	246
351 to ≤ 500 μL		122	122	244
> 500 μL		55	70	125

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

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


Arm/Group Title	Stribild	ATV/r + FTC/TDF
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	353	355
Measure Type: Number Unit of Measure: percentage of participants
	89.5	86.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stribild, ATV/r + FTC/TDF
	Comments	The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + Truvada group with respect to percentage of participants achieving HIV-1 RNA < 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + Truvada 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	3.0
	Confidence Interval	(2-Sided) 95.2% -1.9 to 7.8
	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


Arm/Group Title	Stribild	ATV/r + FTC/TDF
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	353	355
Measure Type: Number Unit of Measure: percentage of participants
	83.3	82.3

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


Arm/Group Title	Stribild	ATV/r + FTC/TDF
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	353	355
Measure Type: Number Unit of Measure: percentage of participants
	77.6	74.6

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	ATV/r + FTC/TDF
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	74	78
Measure Type: Number Unit of Measure: percentage of participants
	78.4	73.1

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	ATV/r + FTC/TDF
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	353	355
Measure Type: Number Unit of Measure: percentage of participants
	86.1	84.8

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 participants with missing data were excluded from analysis.


Arm/Group Title	Stribild	ATV/r + FTC/TDF
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	353	355
Mean (Standard Deviation) Unit of Measure: cells/µL
Change at Wk 48 (Stribild, n=334; ATV/r, n=321)	207 (164.2)	211 (160.3)
Change at Wk 96 (Stribild, n=317; ATV/r, n=315)	256 (166.8)	261 (188.0)
Change at Wk 144 (Stribild, n=297; ATV/r, n=286)	280 (159.8)	293 (211.5)
Change at Wk 192 (Stribild, n=69; ATV/r, n=72)	338 (186.8)	340 (224.2)

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	ATV/r + FTC/TDF
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description:	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
Overall Number of Participants Analyzed	353	355
Measure Type: Number Unit of Measure: percentage of participants
	91.5	88.5

Adverse Events

Time Frame	Adverse events are reported for the double-blind treatment period of Stribild or ATV/r + Truvada up to 216 weeks plus 30 days.
Adverse Event Reporting Description	Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug

Arm/Group Title	Stribild	ATV/r + FTC/TDF
Arm/Group Description	Stribild (EVG 150 mg/COBI 150 mg/FT...	ATV/r 300/100 mg tablet plus FTC 20...
Arm/Group Description	Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily	ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
All-Cause Mortality
	Stribild	ATV/r + FTC/TDF
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Stribild	ATV/r + FTC/TDF
	Affected / at Risk (%)	Affected / at Risk (%)
Total	58/353 (16.43%)	62/355 (17.46%)
Blood and lymphatic system disorders
Thrombocytopenia ^† 1	0/353 (0.00%)	1/355 (0.28%)
Cardiac disorders
Angina pectoris ^† 1	0/353 (0.00%)	1/355 (0.28%)
Myocardial infarction ^† 1	1/353 (0.28%)	2/355 (0.56%)
Congenital, familial and genetic disorders
Congenital ureteric anomaly ^† 1	1/353 (0.28%)	0/355 (0.00%)
Eye disorders
Iridocyclitis ^† 1	0/353 (0.00%)	1/355 (0.28%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/353 (0.28%)	4/355 (1.13%)
Colitis ^† 1	1/353 (0.28%)	1/355 (0.28%)
Constipation ^† 1	1/353 (0.28%)	0/355 (0.00%)
Diarrhoea ^† 1	2/353 (0.57%)	0/355 (0.00%)
Diverticulum ^† 1	1/353 (0.28%)	0/355 (0.00%)
Erosive oesophagitis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Gastritis erosive ^† 1	0/353 (0.00%)	1/355 (0.28%)
Haemorrhoids ^† 1	1/353 (0.28%)	0/355 (0.00%)
Intestinal obstruction ^† 1	0/353 (0.00%)	1/355 (0.28%)
Large intestine perforation ^† 1	0/353 (0.00%)	1/355 (0.28%)
Lower gastrointestinal haemorrhage ^† 1	0/353 (0.00%)	1/355 (0.28%)
Pancreatitis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Peptic ulcer haemorrhage ^† 1	0/353 (0.00%)	1/355 (0.28%)
Vomiting ^† 1	0/353 (0.00%)	1/355 (0.28%)
General disorders
Asthenia ^† 1	0/353 (0.00%)	1/355 (0.28%)
Chest pain ^† 1	1/353 (0.28%)	1/355 (0.28%)
Pyrexia ^† 1	1/353 (0.28%)	0/355 (0.00%)
Hepatobiliary disorders
Bile duct stone ^† 1	0/353 (0.00%)	1/355 (0.28%)
Cholecystitis ^† 1	0/353 (0.00%)	1/355 (0.28%)
Immune system disorders
Drug hypersensitivity ^† 1	1/353 (0.28%)	0/355 (0.00%)
Infections and infestations
Abscess limb ^† 1	0/353 (0.00%)	1/355 (0.28%)
Abscess neck ^† 1	0/353 (0.00%)	1/355 (0.28%)
Anal abscess ^† 1	1/353 (0.28%)	3/355 (0.85%)
Appendicitis ^† 1	3/353 (0.85%)	1/355 (0.28%)
Appendicitis perforated ^† 1	1/353 (0.28%)	0/355 (0.00%)
Arthritis infective ^† 1	1/353 (0.28%)	0/355 (0.00%)
Breast abscess ^† 1	1/353 (0.28%)	0/355 (0.00%)
Bronchitis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Bronchopneumonia ^† 1	0/353 (0.00%)	1/355 (0.28%)
Cellulitis ^† 1	1/353 (0.28%)	2/355 (0.56%)
Device related infection ^† 1	0/353 (0.00%)	1/355 (0.28%)
Ear infection ^† 1	0/353 (0.00%)	1/355 (0.28%)
Epididymitis ^† 1	0/353 (0.00%)	1/355 (0.28%)
Gastroenteritis ^† 1	0/353 (0.00%)	1/355 (0.28%)
Gastroenteritis cryptosporidial ^† 1	1/353 (0.28%)	0/355 (0.00%)
Gastrointestinal infection ^† 1	0/353 (0.00%)	1/355 (0.28%)
Herpes zoster oticus ^† 1	0/353 (0.00%)	1/355 (0.28%)
Impetigo ^† 1	0/353 (0.00%)	1/355 (0.28%)
Incision site infection ^† 1	0/353 (0.00%)	1/355 (0.28%)
Infectious colitis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Influenza ^† 1	1/353 (0.28%)	0/355 (0.00%)
Lymphogranuloma venereum ^† 1	1/353 (0.28%)	0/355 (0.00%)
Malaria ^† 1	1/353 (0.28%)	0/355 (0.00%)
Malignant syphilis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Meningitis aseptic ^† 1	0/353 (0.00%)	1/355 (0.28%)
Meningitis enteroviral ^† 1	0/353 (0.00%)	1/355 (0.28%)
Meningitis viral ^† 1	0/353 (0.00%)	1/355 (0.28%)
Orchitis ^† 1	0/353 (0.00%)	1/355 (0.28%)
Osteomyelitis ^† 1	1/353 (0.28%)	1/355 (0.28%)
Peritonitis ^† 1	2/353 (0.57%)	0/355 (0.00%)
Pilonidal cyst ^† 1	0/353 (0.00%)	1/355 (0.28%)
Pneumocystis jirovecii pneumonia ^† 1	0/353 (0.00%)	1/355 (0.28%)
Pneumonia ^† 1	1/353 (0.28%)	1/355 (0.28%)
Pneumonia bacterial ^† 1	1/353 (0.28%)	0/355 (0.00%)
Pneumonia streptococcal ^† 1	1/353 (0.28%)	0/355 (0.00%)
Pyelonephritis acute ^† 1	0/353 (0.00%)	1/355 (0.28%)
Respiratory syncytial virus infection ^† 1	1/353 (0.28%)	0/355 (0.00%)
Salpingitis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Scrotal abscess ^† 1	0/353 (0.00%)	1/355 (0.28%)
Secondary syphilis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Septic shock ^† 1	0/353 (0.00%)	2/355 (0.56%)
Shigella infection ^† 1	1/353 (0.28%)	0/355 (0.00%)
Staphylococcal infection ^† 1	1/353 (0.28%)	0/355 (0.00%)
Tonsillitis ^† 1	0/353 (0.00%)	1/355 (0.28%)
Urinary tract infection ^† 1	1/353 (0.28%)	0/355 (0.00%)
Viral infection ^† 1	1/353 (0.28%)	0/355 (0.00%)
Injury, poisoning and procedural complications
Alcohol poisoning ^† 1	1/353 (0.28%)	0/355 (0.00%)
Ankle fracture ^† 1	0/353 (0.00%)	1/355 (0.28%)
Clavicle fracture ^† 1	1/353 (0.28%)	0/355 (0.00%)
Femur fracture ^† 1	1/353 (0.28%)	0/355 (0.00%)
Hand fracture ^† 1	0/353 (0.00%)	1/355 (0.28%)
Lower limb fracture ^† 1	0/353 (0.00%)	1/355 (0.28%)
Lumbar vertebral fracture ^† 1	1/353 (0.28%)	0/355 (0.00%)
Muscle rupture ^† 1	1/353 (0.28%)	0/355 (0.00%)
Muscle strain ^† 1	1/353 (0.28%)	0/355 (0.00%)
Overdose ^† 1	2/353 (0.57%)	1/355 (0.28%)
Post concussion syndrome ^† 1	1/353 (0.28%)	0/355 (0.00%)
Post procedural haemorrhage ^† 1	0/353 (0.00%)	1/355 (0.28%)
Skull fractured base ^† 1	1/353 (0.28%)	0/355 (0.00%)
Toxicity to various agents ^† 1	1/353 (0.28%)	2/355 (0.56%)
Upper limb fracture ^† 1	1/353 (0.28%)	1/355 (0.28%)
Wrist fracture ^† 1	0/353 (0.00%)	1/355 (0.28%)
Investigations
Blood creatine phosphokinase increased ^† 1	0/353 (0.00%)	1/355 (0.28%)
Metabolism and nutrition disorders
Dehydration ^† 1	0/353 (0.00%)	1/355 (0.28%)
Hyperkalaemia ^† 1	1/353 (0.28%)	0/355 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/353 (0.00%)	1/355 (0.28%)
Arthritis reactive ^† 1	1/353 (0.28%)	0/355 (0.00%)
Foot deformity ^† 1	0/353 (0.00%)	1/355 (0.28%)
Intervertebral disc displacement ^† 1	0/353 (0.00%)	1/355 (0.28%)
Neck pain ^† 1	0/353 (0.00%)	1/355 (0.28%)
Pain in jaw ^† 1	0/353 (0.00%)	1/355 (0.28%)
Rhabdomyolysis ^† 1	1/353 (0.28%)	1/355 (0.28%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer ^† 1	1/353 (0.28%)	1/355 (0.28%)
Anal squamous cell carcinoma ^† 1	1/353 (0.28%)	0/355 (0.00%)
Anogenital warts ^† 1	0/353 (0.00%)	1/355 (0.28%)
B-cell lymphoma stage II ^† 1	0/353 (0.00%)	1/355 (0.28%)
Basal cell carcinoma ^† 1	0/353 (0.00%)	1/355 (0.28%)
Bladder cancer ^† 1	1/353 (0.28%)	0/355 (0.00%)
Bladder neoplasm ^† 1	1/353 (0.28%)	0/355 (0.00%)
Burkitt's lymphoma ^† 1	1/353 (0.28%)	0/355 (0.00%)
Hodgkin's disease ^† 1	1/353 (0.28%)	1/355 (0.28%)
Nervous system disorders
Cervical radiculopathy ^† 1	1/353 (0.28%)	0/355 (0.00%)
Coma ^† 1	0/353 (0.00%)	1/355 (0.28%)
Convulsion ^† 1	2/353 (0.57%)	0/355 (0.00%)
Critical illness polyneuropathy ^† 1	0/353 (0.00%)	1/355 (0.28%)
Haemorrhage intracranial ^† 1	1/353 (0.28%)	0/355 (0.00%)
Headache ^† 1	0/353 (0.00%)	1/355 (0.28%)
Hypoaesthesia ^† 1	0/353 (0.00%)	1/355 (0.28%)
Syncope ^† 1	1/353 (0.28%)	1/355 (0.28%)
Tension headache ^† 1	1/353 (0.28%)	0/355 (0.00%)
Transient ischaemic attack ^† 1	1/353 (0.28%)	0/355 (0.00%)
VIIth nerve paralysis ^† 1	0/353 (0.00%)	1/355 (0.28%)
Psychiatric disorders
Alcohol withdrawal syndrome ^† 1	1/353 (0.28%)	1/355 (0.28%)
Bipolar disorder ^† 1	0/353 (0.00%)	1/355 (0.28%)
Depressed mood ^† 1	0/353 (0.00%)	1/355 (0.28%)
Depression ^† 1	3/353 (0.85%)	1/355 (0.28%)
Depressive symptom ^† 1	0/353 (0.00%)	1/355 (0.28%)
Drug dependence ^† 1	1/353 (0.28%)	0/355 (0.00%)
Major depression ^† 1	1/353 (0.28%)	0/355 (0.00%)
Mania ^† 1	0/353 (0.00%)	1/355 (0.28%)
Post-traumatic stress disorder ^† 1	1/353 (0.28%)	0/355 (0.00%)
Schizophrenia ^† 1	1/353 (0.28%)	2/355 (0.56%)
Substance abuse ^† 1	0/353 (0.00%)	1/355 (0.28%)
Substance-induced psychotic disorder ^† 1	1/353 (0.28%)	0/355 (0.00%)
Suicidal ideation ^† 1	2/353 (0.57%)	1/355 (0.28%)
Suicide attempt ^† 1	2/353 (0.57%)	2/355 (0.56%)
Renal and urinary disorders
Hydronephrosis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Nephrolithiasis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Renal colic ^† 1	0/353 (0.00%)	1/355 (0.28%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^† 1	1/353 (0.28%)	1/355 (0.28%)
Dyspnoea ^† 1	1/353 (0.28%)	0/355 (0.00%)
Pneumonia aspiration ^† 1	1/353 (0.28%)	1/355 (0.28%)
Respiratory depression ^† 1	0/353 (0.00%)	1/355 (0.28%)
Respiratory distress ^† 1	0/353 (0.00%)	1/355 (0.28%)
Tonsillar hypertrophy ^† 1	1/353 (0.28%)	0/355 (0.00%)
Skin and subcutaneous tissue disorders
Drug eruption ^† 1	0/353 (0.00%)	1/355 (0.28%)
Psoriasis ^† 1	0/353 (0.00%)	1/355 (0.28%)
Social circumstances
Treatment noncompliance ^† 1	0/353 (0.00%)	1/355 (0.28%)
Vascular disorders
Orthostatic hypotension ^† 1	0/353 (0.00%)	1/355 (0.28%)
Peripheral embolism ^† 1	1/353 (0.28%)	0/355 (0.00%)
Thrombophlebitis ^† 1	1/353 (0.28%)	0/355 (0.00%)
Venous thrombosis limb ^† 1	1/353 (0.28%)	0/355 (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	ATV/r + FTC/TDF
	Affected / at Risk (%)	Affected / at Risk (%)
Total	326/353 (92.35%)	326/355 (91.83%)
Blood and lymphatic system disorders
Lymphadenopathy ^† 1	23/353 (6.52%)	16/355 (4.51%)
Eye disorders
Ocular icterus ^† 1	2/353 (0.57%)	52/355 (14.65%)
Gastrointestinal disorders
Abdominal pain ^† 1	25/353 (7.08%)	26/355 (7.32%)
Constipation ^† 1	20/353 (5.67%)	14/355 (3.94%)
Diarrhoea ^† 1	99/353 (28.05%)	121/355 (34.08%)
Dyspepsia ^† 1	13/353 (3.68%)	19/355 (5.35%)
Flatulence ^† 1	16/353 (4.53%)	32/355 (9.01%)
Nausea ^† 1	80/353 (22.66%)	78/355 (21.97%)
Vomiting ^† 1	26/353 (7.37%)	35/355 (9.86%)
General disorders
Fatigue ^† 1	60/353 (17.00%)	60/355 (16.90%)
Pyrexia ^† 1	23/353 (6.52%)	22/355 (6.20%)
Hepatobiliary disorders
Jaundice ^† 1	0/353 (0.00%)	34/355 (9.58%)
Immune system disorders
Seasonal allergy ^† 1	17/353 (4.82%)	19/355 (5.35%)
Infections and infestations
Bronchitis ^† 1	47/353 (13.31%)	42/355 (11.83%)
Chlamydial infection ^† 1	18/353 (5.10%)	17/355 (4.79%)
Folliculitis ^† 1	19/353 (5.38%)	22/355 (6.20%)
Gastroenteritis ^† 1	18/353 (5.10%)	28/355 (7.89%)
Herpes zoster ^† 1	15/353 (4.25%)	20/355 (5.63%)
Influenza ^† 1	31/353 (8.78%)	24/355 (6.76%)
Nasopharyngitis ^† 1	53/353 (15.01%)	57/355 (16.06%)
Onychomycosis ^† 1	21/353 (5.95%)	13/355 (3.66%)
Pharyngitis ^† 1	23/353 (6.52%)	18/355 (5.07%)
Sinusitis ^† 1	35/353 (9.92%)	38/355 (10.70%)
Syphilis ^† 1	27/353 (7.65%)	29/355 (8.17%)
Upper respiratory tract infection ^† 1	86/353 (24.36%)	97/355 (27.32%)
Urinary tract infection ^† 1	18/353 (5.10%)	20/355 (5.63%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	14/353 (3.97%)	19/355 (5.35%)
Vitamin D deficiency ^† 1	21/353 (5.95%)	19/355 (5.35%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	35/353 (9.92%)	32/355 (9.01%)
Back pain ^† 1	46/353 (13.03%)	37/355 (10.42%)
Pain in extremity ^† 1	22/353 (6.23%)	21/355 (5.92%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anorectal human papilloma virus infection ^† 1	21/353 (5.95%)	12/355 (3.38%)
Nervous system disorders
Dizziness ^† 1	25/353 (7.08%)	28/355 (7.89%)
Headache ^† 1	67/353 (18.98%)	55/355 (15.49%)
Paraesthesia ^† 1	9/353 (2.55%)	21/355 (5.92%)
Psychiatric disorders
Anxiety ^† 1	22/353 (6.23%)	29/355 (8.17%)
Depression ^† 1	47/353 (13.31%)	52/355 (14.65%)
Insomnia ^† 1	37/353 (10.48%)	36/355 (10.14%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	38/353 (10.76%)	46/355 (12.96%)
Oropharyngeal pain ^† 1	19/353 (5.38%)	32/355 (9.01%)
Skin and subcutaneous tissue disorders
Night sweats ^† 1	10/353 (2.83%)	18/355 (5.07%)
Rash ^† 1	30/353 (8.50%)	37/355 (10.42%)
Vascular disorders
Hypertension ^† 1	24/353 (6.80%)	12/355 (3.38%)
† 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:

DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.

Rockstroh JK, DeJesus E, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Plummer A, Abram M, Cheng AK, Fordyce MW, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):483-6. doi: 10.1097/QAI.0b013e318286415c.

Clumeck N, Molina JM, Henry K, Gathe J, Rockstroh JK, DeJesus E, Wei X, White K, Fordyce MW, Rhee MS, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus 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):e121-4. doi: 10.1097/QAI.0000000000000089. No abstract available.

Layout table for additonal information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01106586
Other Study ID Numbers:	GS-US-236-0103
First Submitted:	April 14, 2010
First Posted:	April 20, 2010
Results First Submitted:	September 20, 2012
Results First Posted:	October 22, 2012
Last Update Posted:	November 11, 2015

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