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

NCT01475838 | Completed Phase 3 Results

• 2 other identifiers: GS-US-236-01152011-004483-30
• Study Type: interventional
• Target: 438
• Locations: 12 countries
• Sites: 99

Brief 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

Acquired Immunodeficiency Syndrome; HIV Infections

Keywords

HIV-1; HIV; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 48

Secondary Outcomes (3)

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

  Week 96

• Change From Baseline in CD4+ Cell Count at Week 48

  Baseline; Week 48

• Change From Baseline in CD4+ Cell Count at Week 96

  Baseline; Week 96

Study Arms (2)

Stribild

EXPERIMENTAL

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

PI+RTV+FTC/TDF

ACTIVE COMPARATOR

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

PI DRUG

PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)

PI+RTV+FTC/TDF

RTV DRUG

RTV administered according to prescribing information FTC/TDF administered according to prescribing information

PI+RTV+FTC/TDF

FTC/TDF DRUG

FTC/TDF (200/300 mg) administered according to prescribing information

Also known as: Truvada

PI+RTV+FTC/TDF

Stribild DRUG

Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

PI+RTV+FTC/TDF; Stribild

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (99)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

Pueblo Family Physicians

Phoenix, Arizona, 85015, United States

Location

AIDS Healthcare Foundation

Beverly Hills, California, 90211, United States

Location

Pacific Oaks Medical Group

Beverly Hills, California, 90211, United States

Location

Kaiser Permanente

Hayward, California, 94545, United States

Location

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Peter J. Ruane, M.D., Inc.

Los Angeles, California, 90036, United States

Location

OASIS Clinic

Los Angeles, California, 90043, United States

Location

Anthony Mills MD Inc

Los Angeles, California, 90069, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Kaiser Permanente

Sacramento, California, 95841, United States

Location

La Playa Medical Group and Clinical Research

San Diego, California, 92103, United States

Location

Metropolis Medical

San Francisco, California, 94109, United States

Location

Kaiser Permanente San Francisco

San Francisco, California, 94118, United States

Location

Dupont Circle Physicians Group, P.C

Washington D.C., District of Columbia, 20009, United States

Location

Capital Medical Associates, PC

Washington D.C., District of Columbia, 20036, United States

Location

Gary Richmond, MD

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology & Research Center, LLC

Ft. Pierce, Florida, 34982, United States

Location

The Kinder Medical Group

Miami, Florida, 33133, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Idocf/Valuhealthmd, Llc

Orlando, Florida, 32806, United States

Location

Infectious Diseases Associates of NW FL, P.A.

Pensacola, Florida, 32504, United States

Location

AHF Health Positive Tampa Bay

Safety Harbor, Florida, 34695, United States

Location

St. Joseph's Comprehensive Research Institute

Tampa, Florida, 33614, United States

Location

Atlanta ID Group

Atlanta, Georgia, 30309, United States

Location

Northwestern University Division of Infectious Diseases

Chicago, Illinois, 60611, United States

Location

John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center

Chicago, Illinois, 60612, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

The Kansas City Free Health Clinic

Kansas City, Missouri, 64111, United States

Location

I.D. Care Associates PA

Hillsborough, New Jersey, 08844, United States

Location

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

Greiger Clinic

Mount Vernon, New York, 10550, United States

Location

ID Consultants, P.A.

Charlotte, North Carolina, 28209, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Uptown Physicians Group

Dallas, Texas, 75204, United States

Location

Southwest Infectious Disease Clinical Research, Inc

Dallas, Texas, 75219, United States

Location

Tarrant County Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

Therapeutic Concepts, PA

Houston, Texas, 77004, United States

Location

Gordon Crofoot Md, Pa

Houston, Texas, 77098, United States

Location

St. Hope Foundation Inc

Houston, Texas, 77401, United States

Location

Innsbruck Medical University

Innsbruck, A 6020, Austria

Location

Univ.-Kklinik fuer Innere Medizin III

Salzburg, 5020, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Otto-Wagner-Spital

Vienna, 1140, Austria

Location

UCL Saint Luc

Brussels, 01200, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

CHU Sart Tilman

Liège, 4000, Belgium

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Clinique Medicale Du Quartier Latin

Montreal, Quebec, H2L 5B1, Canada

Location

CHU de Besancon, Hopital Saint-Jacques

Besançon, 25030, France

Location

Hôpital de la Croix-Rousse

Lyon, 69317, France

Location

CHU Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

Archet 1 Chu Nice Department of Infectology

Nice, 06202, France

Location

Saint-Louis Hospital

Paris, 75010, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

hôpital Tenon

Paris, 75020, France

Location

Maladies Infectieuses Dpt

Paris, 75651, France

Location

Hôpital Haut Lévêque

Pessac, 33604, France

Location

Epimed GmbH

Berlin, 12157, Germany

Location

University of Bonn

Bonn, 53127, Germany

Location

Infektlonsambulanz Unlkllnik Koln

Cologne, 50937, Germany

Location

Universitätsklinikum Essen, Dermatologie, HIV Ambulanz

Essen, 45147, Germany

Location

Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68

Frankfurt, 60590, Germany

Location

ICH Study Center

Hamburg, 20146, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen

Munich, 80336, Germany

Location

Ospedali Riuniti

Bergamo, 24128, Italy

Location

Fondazione Centro San Raffaele

Milan, 20127, Italy

Location

Clinic of Infectious Diseases, University of Milan-San Paolo Hospital

Milan, 20142, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

National Institute for Infectious Diseases "L. Spallanzani"

Rome, 00149, Italy

Location

University of Torino, Dept of Infectious Disease

Torino, 10122, Italy

Location

HHP Hospital de Cascais

Alcabideche, 2755, Portugal

Location

Hospital de Santa Maria-CHLN, EPE

Lisbon, 1049-035, Portugal

Location

Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa

Lisbon, 1150-069, Portugal

Location

Clinical Research Puert Rico

San Juan, 00909, Puerto Rico

Location

University of Puerto Rico School of Medicine

San Juan, 00935, Puerto Rico

Location

Hospital General Universitario Alicante

Alicante, 03010, Spain

Location

Hospital clinic

Barcelona, 08036, Spain

Location

Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.

Barcelona, 08907, Spain

Location

Hospital Germans Trias I Pujol

Barcelona, 08916, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03202, Spain

Location

Infectious Diseases Department, Hospital Carlos III

Madrid, 28029, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital La Paz

Madrid, 28760, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Geneva University Hospital

Geneva, 1205, Switzerland

Location

University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology

Zurich, 8091, Switzerland

Location

Zentrum fur Infektionskrankheiten

Zurich, CH-8038, Switzerland

Location

Brighton and Sussex University Hospitals NHS Trust

Brighton, BN21ES, United Kingdom

Location

Royal Free Hampstead NHS Trust

London, NW32QG, United Kingdom

Location

Chelsea and Westminster

London, SW109NH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 24908551 RESULT

• 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.

  PMID: 24908550 RESULT

• 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.

  PMID: 28555519 DERIVED

• 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.

  PMID: 26286337 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Thiazoles; Sulfur Compounds; Azoles

Limitations and Caveats

There were no limitations affecting the analysis or results.

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences, Inc.

ClinicalTrialDisclosures@gilead.com

Study Officials

• Thai Nguyen-Cleary

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: June 8, 2016
• Results First Posted: January 26, 2015

Record last verified: 2016-05

Locations

GB (3); ES (9); CA (2); CH (3); DE (9); AU (4); IT (6); PT (3); PR (2); US (45); BE (3); FR (10)