Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

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: NCT01475838

Recruitment Status : Completed

First Posted : November 21, 2011

Results First Posted : January 26, 2015

Last Update Posted : June 8, 2016

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	Acquired Immunodeficiency Syndrome HIV Infections
Interventions	Drug: PI Drug: RTV Drug: FTC/TDF Drug: Stribild
Enrollment	438

Participant Flow

Recruitment Details	Participants were enrolled at study sites in North America and Europe. The first participant was screened on 18 November 2011. The last study visit occurred on 09 December 2014
Pre-assignment Details	632 participants were screened.


Arm/Group Title	Stribild	PI+RTV+FTC/TDF
Arm/Group Description	Participants switched from their ba...	Participants stayed on their baseli...
Arm/Group Description	Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Period Title: Randomized Phase
Started	293	145
Completed	263	109
Not Completed	30	36
Reason Not Completed
Randomized but Not Treated	0	5
Adverse Event	6	1
Pregnancy	0	1
Investigators Discretion	1	2
Withdrew Consent	10	14
Lost to Follow-up	3	4
Participant Noncompliance	1	5
Protocol Violation	9	4
Period Title: Extension Phase
Started	42	20
Completed	41	20
Not Completed	1	0
Reason Not Completed
Participant Noncompliance	1	0

Baseline Characteristics

Arm/Group Title		Stribild	PI+RTV+FTC/TDF	Total
Arm/Group Description		Participants switched from their ba...	Participants stayed on their baseli...	Total of all reporting groups
Arm/Group Description		Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.	Total of all reporting groups
Overall Number of Baseline Participants		293	140	433
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	293 participants	140 participants	433 participants
		41 (9.7)	41 (8.9)	41 (9.4)
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	293 participants	140 participants	433 participants
< 40 years		130	68	198
≥ 40 to < 50 years		109	49	158
≥ 50 years		54	23	77
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	293 participants	140 participants	433 participants
	Female	43 14.7%	19 13.6%	62 14.3%
	Male	250 85.3%	121 86.4%	371 85.7%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	293 participants	140 participants	433 participants
American Indian or Alaska Native		2	1	3
Asian		7	2	9
Black or African Heritage		43	20	63
White		234	113	347
Other		5	2	7
Not Permitted		2	2	4
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	293 participants	140 participants	433 participants
Hispanic or Latino		42	17	59
Non-Hispanic/Latino		249	123	372
Not Permitted		2	0	2
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	293 participants	140 participants	433 participants
Portugal		12	7	19
France		39	15	54
United States		84	40	124
Puerto Rico		3	2	5
Canada		5	3	8
Spain		28	21	49
Belgium		6	2	8
Austria		11	4	15
Germany		36	21	57
United Kingdom		13	1	14
Switzerland		12	8	20
Italy		44	16	60
HIV-1 RNA Category Measure Type: Number Unit of measure: Participants	Number Analyzed	293 participants	140 participants	433 participants
< 50 copies/mL		291	137	428
50 to < 200 copies/mL		2	2	4
200 to < 400 copies/mL		0	0	0
≥ 400 copies/mL		0	1	1
CD4+ Cell Count Mean (Standard Deviation) Unit of measure: cells/µL
	Number Analyzed	293 participants	140 participants	433 participants
		604 (274.6)	624 (269.9)	610 (272.9)
CD4+ Cell Count Category Measure Type: Number Unit of measure: Participants	Number Analyzed	293 participants	140 participants	433 participants
≤ 50 cells/µL		0	0	0
51 to ≤ 200 cells/µL		9	6	15
201 to ≤ 350 cells/µL		37	14	51
351 to ≤ 500 cells/µL		69	26	95
> 500 cells/µL		178	94	272
HIV Disease Status Measure Type: Number Unit of measure: Participants	Number Analyzed	293 participants	140 participants	433 participants
Asymptomatic		214	105	319
Symptomatic HIV Infections		38	17	55
AIDS		41	18	59

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Description	The FDA-defined Snapshot algorithm was used, which defines a patient's...
Description	The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Full Analysis Set: Participants who were randomized and treated, and had no major eligibility criteria violations


Arm/Group Title	Stribild	PI+RTV+FTC/TDF
Arm/Group Description:	Participants switched from their ba...	Participants stayed on their baseli...
Arm/Group Description:	Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Overall Number of Participants Analyzed	290	139
Measure Type: Number Unit of Measure: percentage of participants
	93.8	87.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stribild, PI+RTV+FTC/TDF
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The null hypothesis was that the Stribild group was at least 12% worse than the PI+RTV+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA < 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the PI+RTV+FTC/TDF group.

Statistical Test of Hypothesis	P-Value	0.025
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in proportions
	Estimated Value	6.7
	Confidence Interval	(2-Sided) 95% 0.4 to 13.7
	Estimation Comments	The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.

2.Secondary Outcome


Title	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Description	The FDA-defined Snapshot algorithm was used, which defines a patient's...
Description	The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Full Analysis Set


Arm/Group Title	Stribild	PI+RTV+FTC/TDF
Arm/Group Description:	Participants switched from their ba...	Participants stayed on their baseli...
Arm/Group Description:	Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Overall Number of Participants Analyzed	290	139
Measure Type: Number Unit of Measure: percentage of participants
	86.9	69.8

3.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

Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.


Arm/Group Title	Stribild	PI+RTV+FTC/TDF
Arm/Group Description:	Participants switched from their ba...	Participants stayed on their baseli...
Arm/Group Description:	Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Overall Number of Participants Analyzed	270	120
Mean (Standard Deviation) Unit of Measure: cells/µL
	40 (169.5)	32 (166.1)

4.Secondary Outcome


Title	Change From Baseline in CD4+ Cell Count at Week 96
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline; Week 96

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.


Arm/Group Title	Stribild	PI+RTV+FTC/TDF
Arm/Group Description:	Participants switched from their ba...	Participants stayed on their baseli...
Arm/Group Description:	Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Overall Number of Participants Analyzed	255	104
Mean (Standard Deviation) Unit of Measure: cells/µL
	61 (196.5)	71 (173.4)

Adverse Events

Time Frame	Baseline through end of study (average 88 weeks)
Adverse Event Reporting Description	Safety Analysis Set: participants were randomized and received at least 1 dose of study drug

Arm/Group Title	Stribild	PI+RTV+FTC/TDF	All Stribild
Arm/Group Description	Adverse events for this reporting g...	Adverse events for this reporting g...	Adverse events for this reporting g...
Arm/Group Description	Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase. Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	Adverse events for this reporting group include those occurring in participants receiving PI+RTV+FTC/TDF in the randomized phase. Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.	Adverse events for this reporting group include those occurring in participants while receiving Stribild in the randomized and extension phases.
All-Cause Mortality
	Stribild	PI+RTV+FTC/TDF	All Stribild
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Stribild	PI+RTV+FTC/TDF	All Stribild
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	24/293 (8.19%)	11/140 (7.86%)	24/313 (7.67%)
Cardiac disorders
Acute myocardial infarction ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Endocrine disorders
Goitre ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Eye disorders
Visual acuity reduced ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Gastrointestinal disorders
Abdominal pain ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Enteritis ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Gastric haemorrhage ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Rectal haemorrhage ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
General disorders
Drug withdrawal syndrome ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Infections and infestations
Anal abscess ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Appendicitis ^† 1	1/293 (0.34%)	1/140 (0.71%)	1/313 (0.32%)
Bronchitis ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Encephalitis ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Gastroenteritis ^† 1	1/293 (0.34%)	1/140 (0.71%)	1/313 (0.32%)
Gastroenteritis norovirus ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Infective exacerbation of chronic obstructive airways disease ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Penile abscess ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Pneumonia ^† 1	2/293 (0.68%)	0/140 (0.00%)	2/313 (0.64%)
Rectal abscess ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Injury, poisoning and procedural complications
Alcohol poisoning ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Radius fracture ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Toxicity to various agents ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Wound ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Musculoskeletal and connective tissue disorders
Arthritis reactive ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Myalgia ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Osteonecrosis ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Hodgkin's disease ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Invasive lobular breast carcinoma ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Metastases to liver ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Transitional cell carcinoma ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Nervous system disorders
Headache ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Transient ischaemic attack ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Psychiatric disorders
Alcohol withdrawal syndrome ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Anxiety ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Bipolar I disorder ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Drug abuse ^† 1	0/293 (0.00%)	1/140 (0.71%)	0/313 (0.00%)
Major depression ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Psychotic disorder ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Suicide attempt ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Reproductive system and breast disorders
Benign prostatic hyperplasia ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Respiratory, thoracic and mediastinal disorders
Asthma ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Vascular disorders
Arteriosclerosis ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
Deep vein thrombosis ^† 1	1/293 (0.34%)	0/140 (0.00%)	1/313 (0.32%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (17.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Stribild	PI+RTV+FTC/TDF	All Stribild
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	169/293 (57.68%)	67/140 (47.86%)	169/313 (53.99%)
Gastrointestinal disorders
Diarrhoea ^† 1	27/293 (9.22%)	11/140 (7.86%)	27/313 (8.63%)
Nausea ^† 1	22/293 (7.51%)	5/140 (3.57%)	22/313 (7.03%)
Infections and infestations
Gastroenteritis ^† 1	11/293 (3.75%)	7/140 (5.00%)	11/313 (3.51%)
Nasopharyngitis ^† 1	39/293 (13.31%)	20/140 (14.29%)	39/313 (12.46%)
Pharyngitis ^† 1	16/293 (5.46%)	7/140 (5.00%)	16/313 (5.11%)
Sinusitis ^† 1	15/293 (5.12%)	6/140 (4.29%)	16/313 (5.11%)
Syphilis ^† 1	20/293 (6.83%)	6/140 (4.29%)	20/313 (6.39%)
Upper respiratory tract infection ^† 1	29/293 (9.90%)	8/140 (5.71%)	29/313 (9.27%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	15/293 (5.12%)	4/140 (2.86%)	15/313 (4.79%)
Back pain ^† 1	24/293 (8.19%)	4/140 (2.86%)	24/313 (7.67%)
Nervous system disorders
Headache ^† 1	24/293 (8.19%)	10/140 (7.14%)	24/313 (7.67%)
Psychiatric disorders
Anxiety ^† 1	19/293 (6.48%)	5/140 (3.57%)	20/313 (6.39%)
Depression ^† 1	18/293 (6.14%)	9/140 (6.43%)	18/313 (5.75%)
Insomnia ^† 1	13/293 (4.44%)	8/140 (5.71%)	13/313 (4.15%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	20/293 (6.83%)	6/140 (4.29%)	20/313 (6.39%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (17.1)

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:

Arribas JR, Pialoux G, Gathe J, Di Perri G, Reynes J, Tebas P, Nguyen T, Ebrahimi R, White K, Piontkowsky D. Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):581-9. doi: 10.1016/S1473-3099(14)70782-0. Epub 2014 Jun 5.

Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arribas JR, DeJesus E, van Lunzen J, Zurawski C, Doroana M, Towner W, Lazzarin A, Nelson M, McColl D, Andreatta K, Swamy R, Szwarcberg J, Nguyen T. Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI. HIV Clin Trials. 2017 May;18(3):118-125. doi: 10.1080/15284336.2017.1330440. Epub 2017 May 30. Erratum in: HIV Clin Trials. 2018 Aug;19(4):163.

Gathe J, Arribas JR, Van Lunzen J, Garner W, Speck RM, Bender R, Shreay S, Nguyen T. Patient-Reported Symptoms over 48 Weeks in a Randomized, Open-Label, Phase 3b Non-inferiority Trial of Adults with HIV Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF Versus Continuation of Ritonavir-Boosted Protease Inhibitor with Emtricitabine and Tenofovir DF. Patient. 2015 Oct;8(5):445-54. doi: 10.1007/s40271-015-0137-9.

Layout table for additonal information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01475838
Other Study ID Numbers:	GS-US-236-0115 2011-004483-30 ( EudraCT Number )
First Submitted:	November 17, 2011
First Posted:	November 21, 2011
Results First Submitted:	January 8, 2015
Results First Posted:	January 26, 2015
Last Update Posted:	June 8, 2016

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