Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

NCT01495702 | Completed Phase 3 Results

• 2 other identifiers: GS-US-236-01212011-004963-56
• Study Type: interventional
• Target: 439
• Locations: 11 countries
• Sites: 78

Brief Summary

This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) 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

NNRTI+FTC/TDF

ACTIVE COMPARATOR

Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.

Drug: NNRTI; Drug: FTC/TDF; Drug: Stribild

Interventions

NNRTI DRUG

NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.

NNRTI+FTC/TDF

FTC/TDF DRUG

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

Also known as: Truvada

NNRTI+FTC/TDF

Stribild DRUG

Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

NNRTI+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 stable on the current formulation(s) of an antiretroviral regimen consisting of an NNRTI plus FTC/TDF for ≥ 6 consecutive months preceding the screening visit. This includes those who began a regimen with individual drug components and subsequently simplified to include a fixed-dose combination formulation of the same drugs.
• Be on the first or second antiretroviral regimen with 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
• Adequate hematologic function
• Serum amylase ≤ 5 × ULN
• Estimated glomerular filtration rate ≥ 70 mL/min
• Females of childbearing potential must agree to utilize protocol recommended contraception methods or be nonheterosexually active, practice sexual abstinence from screening throughout the duration of the study period and for 12 weeks for participants on EFV/FTC/TDF or efavirenz or 30 days for the rest of participants 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 protocol-recommended methods of contraception during heterosexual intercourse or be nonheterosexually active, and practice sexual abstinence from the screening visit.

You may not qualify if:

• 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 those 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 (KS), basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma. Persons with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and must not be anticipated to require systemic therapy during the study.
• Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
• 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 (80)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

AHF Research Center

Beverly Hills, California, 90211, United States

Location

Pacific Oak Medical Group

Beverly Hills, California, 90211, United States

Location

Kaiser Permanente

Hayward, California, 94545, United States

Location

Peter J. Ruane, MD, Inc.

Los Angeles, California, 90036, United States

Location

OASIS Clinic

Los Angeles, California, 90059, United States

Location

Anthony Mills MD Inc

Los Angeles, California, 90069, United States

Location

Alameda County Medical Center

Oakland, California, 94602, United States

Location

Kaiser Permanente Medical Group

Sacramento, California, 95825, 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, California, 94118, United States

Location

Dupont Circle Physicians Group, P.C.

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

Location

Capital Medical Associates, P.C.

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

Location

Gary Richmond MD, PA, Inc

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology and Research

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

ValuHealth MD, LLC

Orlando, Florida, 32806, United States

Location

Infectious Diseases Associates of Northwest Florida

Pensacola, Florida, 32504, United States

Location

Health Positive

Safety Harbor, Florida, 34684, United States

Location

Atlanta ID Group, PC

Atlanta, Georgia, 30309, United States

Location

Infectious Disease Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

HIV Program Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

The Kansas City Free Health Clinic

Kansas City, Missouri, 64111, United States

Location

ID Care

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

Aaron Diamond AIDS Research Center

New York, New York, 10016, 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

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

Southwest Infectious Disease Clinical Researach 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 E. Crofoot MD, PA

Houston, Texas, 77098, United States

Location

Clinical Alliance for Research & Education - Infectious Disease

Annandale, Virginia, 22003, United States

Location

Holdsworth House Medical Practice

Darlinghurst, NSW 2010, Australia

Location

Prahran Market Clinic

South Yarra, VIC 3141, Australia

Location

East Sydney Doctors

Sydney, NSW 2010, Australia

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Otto Wagner Spital

Vienna, 1140, Austria

Location

SEAMEO Regional Centre for Tropical Medicine

Antwerp, 2000, Belgium

Location

Hôpitaux IRIS Sud

Brussels, 1050, Belgium

Location

University Hospital of Leuven

Leuven, 3000, Belgium

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

Maple Leaf Medical Clinic

Toronto, Ontario, M5B1L6, Canada

Location

Clinique Medicale Du Quartier Latin

Montreal, Quebec, H2L 5B1, Canada

Location

CHU de Besancon - Hopital Saint-Jacques

Besançon, 25030, France

Location

Groupe Hospitalier Pellegrin

Bordeaux, 33079, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital Bichat Claude Bernard

Paris, 75018, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

EPIMED GmbH

Berlin, 12157, Germany

Location

MIB Dienstleistung GmbH

Berlin, 13353, Germany

Location

Medizinische Universitätsklinik

Bonn, 53127, Germany

Location

Infektiologikum

Frankfurt, 60596, Germany

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

ICH Study Center

Hamburg, 20146, Germany

Location

MUC Research GmbH

München, 80335, Germany

Location

Azienda Ospedaliera Ospedale di Circolo Busto Arsizio

Busto Arsizio/Varese, 21052, Italy

Location

Fondazione Centro San Raffaele del Monte Tabor

Milan, 20127, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

Roma, 00149, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, 1214, Italy

Location

Hospital de Santa Maria - CHLN EPE

Lisbon, 1649-035, Portugal

Location

Clinical Research Puerto Rico Inc

San Juan, Puerto Rica, 00909, Puerto Rico

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital La Fe de Valencia

Valencia, 46009, Spain

Location

Brighton and Sussex University Hospitals NHS Trust

Brighton, BN2 1ES, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Homerton University Hospital

London, E9 6SR, United Kingdom

Location

South London Healthcare NHS Trust

London, SE1 1EE, United Kingdom

Location

St. Thomas' Hospital

London, SE17EH, United Kingdom

Location

Chelsea & Westminster Hospital

London, SW10 9TH, United Kingdom

Location

Related Publications (2)

• Pozniak A, Flamm J, Antinori A, Bloch M, Ward D, Berenguer J, Cote P, Andreatta K, Garner W, Szwarcberg J, Nguyen-Cleary T, McColl DJ, Piontkowsky D. Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI. HIV Clin Trials. 2017 Jul;18(4):141-148. doi: 10.1080/15284336.2017.1338844. Epub 2017 Jul 9.

  PMID: 28689453 DERIVED

• 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 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

• Damian McColl

  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: December 14, 2011
• First Posted: December 20, 2011
• Study Start: December 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 7, 2016
• Results First Posted: January 26, 2015

Record last verified: 2015-12

Locations

PT (1); IT (5); AU (3); ES (5); BE (3); FR (5); CA (3); DE (7); PR (1); GB (6); US (39)