CompletedNCT01475838Updated Jun 8, 2016Results posted

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

A Phase 3 interventional study of PI and RTV in Acquired Immunodeficiency Syndrome and HIV Infections, sponsored by Gilead Sciences. Completed at 99 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-08.

Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 438
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Conditions studied

Acquired Immunodeficiency Syndrome
HIV Infections

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Keywords

HIV-1
HIV
Treatment Experienced

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 438 is above the median of 83 across 3,250 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Ability to understand and sign a written informed consent form
Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plus FTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit
Be on the first or second antiretroviral drug regimen documented undetectable plasma HIV 1 RNA levels for ≥ 6 months preceding the screening visit
No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time
Documented historical genotype prior to starting initial antiretroviral therapy showing no known resistance to TDF or FTC
HIV RNA \< 50 copies/mL at screening
Normal ECG
Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 × ULN
Estimated glomerular filtration rate ≥ 70 mL/min
Females of childbearing potential must agree to utilize highly effective contraception methods, or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug
Female participants who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
Male participants must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product, or must be nonheterosexually active, or practice sexual abstinence
Age ≥ 18 years

Exclusion criteria

Exclusion Criteria:

A new AIDS-defining condition diagnosed within the 30 days prior to screening
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Receiving drug treatment for hepatitis C, or participants who are anticipated to receive treatment for hepatitis C during the course of the study
Experiencing decompensated cirrhosis
Have an implanted defibrillator or pacemaker
Current alcohol or substance abuse that would interfere with compliance
A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline, except for intramuscular penicillin for the treatment of syphilis
Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study
Receiving ongoing therapy with any of the medications, including drugs not to be used with elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to the excipients of E/C/F/TDF tablets, or FTC/TDF tablets
No anticipated need to initiate drugs during the study that are contraindicated
Receiving other investigational drugs
Participation in any other clinical trial
Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 438 participants (actual)

Study arms

Experimental
Stribild
Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase.
Drug: Stribild
Active comparator
PI+RTV+FTC/TDF
Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of a PI boosted with RTV plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.
Drug: PI · Drug: RTV · Drug: FTC/TDF · Drug: Stribild

Interventions

DrugPI
PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)
DrugRTV
RTV administered according to prescribing information FTC/TDF administered according to prescribing information
DrugFTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information
Also known as: Truvada
DrugStribild
Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

What researchers measure

Primary outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
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

Secondary outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
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
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 96
Time frame: Baseline; Week 96

Results

Posted Jan 26, 2015

Limitations and caveats

There were no limitations affecting the analysis or results.

Participant flow

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

Randomized Phase

Participant flow — Randomized Phase
Milestone	Stribild	PI+RTV+FTC/TDF
Started	293	145
Completed	263	109
Not completed	30	36
Withdrew: Randomized but not treated	0	5
Withdrew: Adverse event	6	1
Withdrew: Pregnancy	0	1
Withdrew: Investigators discretion	1	2
Withdrew: Withdrew consent	10	14
Withdrew: Lost to follow-up	3	4
Withdrew: Participant noncompliance	1	5
Withdrew: Protocol violation	9	4

Extension Phase

Participant flow — Extension Phase
Milestone	Stribild	PI+RTV+FTC/TDF
Started	42	20
Completed	41	20
Not completed	1	0
Withdrew: Participant noncompliance	1	0

Outcome measures

PrimaryPercentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

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
Reported as:: Number · percentage of participants

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
percentage of participants	Stribild	PI+RTV+FTC/TDF
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48	93.8	87.1

Statistical analysis

Stribild vs PI+RTV+FTC/TDF · Fisher Exact · p = 0.025 · Difference in proportions: 6.7 · 95% CI 0.4 to 13.7The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.

SecondaryPercentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

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
Reported as:: Number · percentage of participants

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
percentage of participants	Stribild	PI+RTV+FTC/TDF
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	86.9	69.8

SecondaryChange From Baseline in CD4+ Cell Count at Week 48

Time frame:: Baseline; Week 48
Reported as:: Mean · cells/µL

Change From Baseline in CD4+ Cell Count at Week 48
cells/µL	Stribild	PI+RTV+FTC/TDF
Change From Baseline in CD4+ Cell Count at Week 48	40 ± 169.5	32 ± 166.1

SecondaryChange From Baseline in CD4+ Cell Count at Week 96

Time frame:: Baseline; Week 96
Reported as:: Mean · cells/µL

Change From Baseline in CD4+ Cell Count at Week 96
cells/µL	Stribild	PI+RTV+FTC/TDF
Change From Baseline in CD4+ Cell Count at Week 96	61 ± 196.5	71 ± 173.4

Adverse events

Collected over Baseline through end of study (average 88 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Stribild	—	24/293 (8.2%)	169/293 (57.7%)
PI+RTV+FTC/TDF	—	11/140 (7.9%)	67/140 (47.9%)
All Stribild	—	24/313 (7.7%)	169/313 (54%)

Most frequent serious events

Showing 10 of 43

Most frequent serious events
Event	Stribild	PI+RTV+FTC/TDF	All Stribild
Acute myocardial infarctionCardiac disorders	0/293	1/140	0/313
Anal abscessInfections and infestations	0/293	1/140	0/313
AppendicitisInfections and infestations	1/293	1/140	1/313
BronchitisInfections and infestations	0/293	1/140	0/313
GastroenteritisInfections and infestations	1/293	1/140	1/313
Rectal abscessInfections and infestations	0/293	1/140	0/313
WoundInjury, poisoning and procedural complications	0/293	1/140	0/313
OsteonecrosisMusculoskeletal and connective tissue disorders	0/293	1/140	0/313
Bronchial carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/293	1/140	0/313
Metastases to liverNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/293	1/140	0/313

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Stribild	PI+RTV+FTC/TDF	All Stribild
NasopharyngitisInfections and infestations	39/293	20/140	39/313
Upper respiratory tract infectionInfections and infestations	29/293	8/140	29/313
DiarrhoeaGastrointestinal disorders	27/293	11/140	27/313
Back painMusculoskeletal and connective tissue disorders	24/293	4/140	24/313
HeadacheNervous system disorders	24/293	10/140	24/313
NauseaGastrointestinal disorders	22/293	5/140	22/313
SyphilisInfections and infestations	20/293	6/140	20/313
CoughRespiratory, thoracic and mediastinal disorders	20/293	6/140	20/313
AnxietyPsychiatric disorders	19/293	5/140	20/313
DepressionPsychiatric disorders	18/293	9/140	18/313

Baseline characteristics

Safety Analysis Set: participants were randomized and received at least one dose of study medication.

Age, Continuous
Age, Continuous(years)	Stribild	PI+RTV+FTC/TDF	Total
Mean	41 ± 9.7	41 ± 8.9	41 ± 9.4

Age, Customized
Age, Customized(participants)	Stribild	PI+RTV+FTC/TDF	Total
< 40 years	130	68	198
≥ 40 to < 50 years	109	49	158
≥ 50 years	54	23	77

Sex: Female, Male
Sex: Female, Male(Participants)	Stribild	PI+RTV+FTC/TDF	Total
Female	43	19	62
Male	250	121	371

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Stribild	PI+RTV+FTC/TDF	Total
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
Race/Ethnicity, Customized(participants)	Stribild	PI+RTV+FTC/TDF	Total
Hispanic or Latino	42	17	59
Non-Hispanic/Latino	249	123	372
Not Permitted	2	0	2

Region of Enrollment
Region of Enrollment(participants)	Stribild	PI+RTV+FTC/TDF	Total
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
HIV-1 RNA Category(participants)	Stribild	PI+RTV+FTC/TDF	Total
< 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
CD4+ Cell Count(cells/µL)	Stribild	PI+RTV+FTC/TDF	Total
Mean	604 ± 274.6	624 ± 269.9	610 ± 272.9

2 further baseline measures are reported on the registry.

Study locations

99 sites

Spectrum Medical Group
Phoenix, Arizona 85012, United States
Pueblo Family Physicians
Phoenix, Arizona 85015, United States
AIDS Healthcare Foundation
Beverly Hills, California 90211, United States
Pacific Oaks Medical Group
Beverly Hills, California 90211, United States
Kaiser Permanente
Hayward, California 94545, United States
Kaiser Permanente
Los Angeles, California 90027, United States
Peter J. Ruane, M.D., Inc.
Los Angeles, California 90036, United States
OASIS Clinic
Los Angeles, California 90043, United States
Anthony Mills MD Inc
Los Angeles, California 90069, United States
Stanford University
Palo Alto, California 94304, United States
University of California, Davis
Sacramento, California 95817, United States
Kaiser Permanente
Sacramento, California 95841, United States
La Playa Medical Group and Clinical Research
San Diego, California 92103, United States
Metropolis Medical
San Francisco, California 94109, United States
Kaiser Permanente San Francisco
San Francisco, California 94118, United States
Dupont Circle Physicians Group, P.C
Washington, District of Columbia 20009, United States
Capital Medical Associates, PC
Washington, District of Columbia 20036, United States
Gary Richmond, MD
Fort Lauderdale, Florida 33316, United States
Midway Immunology & Research Center, LLC
Fort Pierce, Florida 34982, United States
The Kinder Medical Group
Miami, Florida 33133, United States
Orlando Immunology Center
Orlando, Florida 32803, United States
Idocf/Valuhealthmd, Llc
Orlando, Florida 32806, United States
Infectious Diseases Associates of NW FL, P.A.
Pensacola, Florida 32504, United States
AHF Health Positive Tampa Bay
Safety Harbor, Florida 34695, United States
St. Joseph's Comprehensive Research Institute
Tampa, Florida 33614, United States
Atlanta ID Group
Atlanta, Georgia 30309, United States
Northwestern University Division of Infectious Diseases
Chicago, Illinois 60611, United States
John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center
Chicago, Illinois 60612, United States
Be Well Medical Center
Berkley, Michigan 48072, United States
Hennepin County Medical Center
Minneapolis, Minnesota 55415, United States
The Kansas City Free Health Clinic
Kansas City, Missouri 64111, United States
I.D. Care Associates PA
Hillsborough, New Jersey 08844, United States
Saint Michael's Medical Center
Newark, New Jersey 07102, United States
South Jersey Infectious Disease
Somers Point, New Jersey 08244, United States
Greiger Clinic
Mt. Vernon, New York 10550, United States
ID Consultants, P.A.
Charlotte, North Carolina 28209, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157, United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania 19107, United States
Uptown Physicians Group
Dallas, Texas 75204, United States
Southwest Infectious Disease Clinical Research, Inc
Dallas, Texas 75219, United States
Tarrant County Infectious Disease Associates
Fort Worth, Texas 76104, United States
Therapeutic Concepts, PA
Houston, Texas 77004, United States
Gordon Crofoot Md, Pa
Houston, Texas 77098, United States
St. Hope Foundation Inc
Houston, Texas 77401, United States
Innsbruck Medical University
Innsbruck, A 6020, Austria
Univ.-Kklinik fuer Innere Medizin III
Salzburg, 5020, Austria
Medical University of Vienna
Vienna, 1090, Austria
Otto-Wagner-Spital
Wien, 1140, Austria
UCL Saint Luc
Brussels, 01200, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
CHU Sart Tilman
Liege, 4000, Belgium
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5, Canada
Clinique Medicale Du Quartier Latin
Montreal, Quebec H2L 5B1, Canada
CHU de Besancon, Hopital Saint-Jacques
Besançon, 25030, France
Hôpital de la Croix-Rousse
Lyon, 69317, France
CHU Hôpital Gui de Chauliac
Montpellier, 34295, France
Archet 1 Chu Nice Department of Infectology
Nice, 06202, France
Maladies Infectieuses Dpt
Paris Cedex 13, 75651, France
Saint-Louis Hospital
Paris, 75010, France
Hopital Saint Antoine
Paris, 75012, France
Hôpital Bichat-Claude Bernard
Paris, 75018, France
hôpital Tenon
Paris, 75020, France
Hôpital Haut Lévêque
Pessac, 33604, France
Epimed GmbH
Berlin, 12157, Germany
University of Bonn
Bonn, 53127, Germany
Universitätsklinikum Essen, Dermatologie, HIV Ambulanz
Essen, 45147, Germany
Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68
Frankfurt, 60590, Germany
ICH Study Center
Hamburg, 20146, Germany
Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hannover, 30625, Germany
Infektlonsambulanz Unlkllnik Koln
Koln, 50937, Germany
Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen
Munich, 80336, Germany
Ospedali Riuniti
Bergamo, 24128, Italy
Fondazione Centro San Raffaele
Milano, 20127, Italy
Clinic of Infectious Diseases, University of Milan-San Paolo Hospital
Milano, 20142, Italy
Ospedale Luigi Sacco
Milano, 20157, Italy
National Institute for Infectious Diseases "L. Spallanzani"
Rome, 00149, Italy
University of Torino, Dept of Infectious Disease
Torino, 10122, Italy
HHP Hospital de Cascais
Alcabideche, 2755, Portugal
Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa
Lisboa, 1150-069, Portugal
Hospital de Santa Maria-CHLN, EPE
Lisbon, 1049-035, Portugal
Clinical Research Puert Rico
San Juan, 00909, Puerto Rico
University of Puerto Rico School of Medicine
San Juan, 00935, Puerto Rico
Hospital General Universitario Alicante
Alicante, 03010, Spain
Hospital clinic
Barcelona, 08036, Spain
Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.
Barcelona, 08907, Spain
Hospital Germans Trias I Pujol
Barcelona, 08916, Spain
Hospital General Universitario de Elche
Elche, Alicante, 03202, Spain
Infectious Diseases Department, Hospital Carlos III
Madrid, 28029, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital La Paz
Madrid, 28760, Spain
Hospital Virgen del Rocio
Sevilla, 41013, Spain
Geneva University Hospital
Geneva, 1205, Switzerland
University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology
Zurich, 8091, Switzerland
Zentrum fur Infektionskrankheiten
Zurich, CH-8038, Switzerland
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN21ES, United Kingdom
Royal Free Hampstead NHS Trust
London, NW32QG, United Kingdom
Chelsea and Westminster
London, SW109NH, United Kingdom

References and documents

Publications

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. PubMed 24908551 ↗
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. PubMed 24908550 ↗
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. doi: 10.1080/15284336.2018.1436794. PubMed 28555519 ↗
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. PubMed 26286337 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01475838
Lead sponsor: Gilead Sciences
Responsible party: Sponsor
First posted: Nov 21, 2011
Start date: Nov 2011
Primary completion: Nov 2013
Completion: Dec 2014
Results posted: Jan 26, 2015
Last update: Jun 8, 2016

Study contacts

Thai Nguyen-Cleary

study director · Gilead Sciences

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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