Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

NCT01309243 | Completed Phase 3 Results

• 1 other identifier: GS-US-264-0110
• Study Type: interventional
• Target: 799
• Locations: 13 countries
• Sites: 143

Brief Summary

The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications. Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

Conditions

HIV-1 Infection

Keywords

HIV; HIV-1; Antiretroviral Treatment-Naïve

Outcome Measures

Primary Outcomes (1)

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

  The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm. The snapshot algorithm 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 (9)

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

  Baseline to Week 96

• Change From Baseline in CD4 Cell Count at Week 48

  Baseline to Week 48

• Change From Baseline in CD4 Cell Count at Week 96

  Baseline to Week 96

• Change From Baseline in Fasting Total Cholesterol at Week 48

  Baseline to Week 48

• Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48

  Baseline to Week 48

Study Arms (2)

FTC/RPV/TDF

EXPERIMENTAL

Drug: FTC/RPV/TDF

EFV/FTC/TDF

EXPERIMENTAL

Drug: EFV/FTC/TDF

Interventions

FTC/RPV/TDF DRUG

Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally once daily with a meal

Also known as: Complera®, Eviplera®

FTC/RPV/TDF

EFV/FTC/TDF DRUG

Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg single-tablet regimen administered orally once daily on an empty stomach, preferably at bedtime

Also known as: Atripla®

EFV/FTC/TDF

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
• Plasma HIV-1 RNA levels ≥ 2,500 copies/mL at screening
• No prior use of any approved or experimental anti-HIV drug for any length of time
• Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y
• Normal ECG
• Hepatic transaminases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) ≤ 5 x the upper limit of the normal range (ULN)
• Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
• Adequate hematologic function
• Serum amylase ≤ 5 x ULN (participants with serum amylase \> 5 x ULN remained eligible if serum lipase was ≤ 5 x ULN)
• Adequate renal function
• Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study period and for 12 weeks following the last dose of study drug.
• Adult (≥ 18 years) males or non-pregnant females

You may not qualify if:

• A new AIDS-defining condition diagnosed within the 30 days prior to screening
• Females who were breastfeeding
• Positive serum pregnancy test (female of childbearing potential)
• Proven or suspected acute hepatitis in the 30 days prior to study entry
• Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated to receive treatment for hepatitis C during the course of the study
• Subjects experiencing decompensated cirrhosis
• Had an implanted defibrillator or pacemaker
• Current alcohol or substance abuse
• A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
• Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
• Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens
• Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial.
• Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids for immunosuppression during the study (eg, corticosteroids, immunoglobulins, and other immune-based or cytokine-based therapies)
• Had any other clinical condition or prior therapy that, in the opinion of the Investigator, would have made the participant unsuitable for the study or unable to comply with the dosing requirements

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (151)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

AHF Research Center

Beverly Hills, California, 90211, United States

Location

Kaiser Permanente Medical Center

Hayward, California, 94545, United States

Location

Living Hope Education and Research Consultants

Long Beach, California, 90813, United States

Location

Kaiser Permanente Medical Center

Los Angeles, California, 90027, United States

Location

Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center

Los Angeles, California, 90028, United States

Location

Lightsource Medical

Los Angeles, California, 90036, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Oasis Clinic

Los Angeles, California, 90059, United States

Location

Anthony Mills MD Inc

Los Angeles, California, 90069, United States

Location

Orange Coast Medical Group

Newport Beach, California, 92663, United States

Location

East Bay AIDS Center

Oakland, California, 94609, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California, Davis

Sacramento, California, 95817, 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/Dr.Fritz

San Francisco, California, 94114, United States

Location

Kaiser Permanente Medical Center, San Francisco

San Francisco, California, 94118, United States

Location

Apex Research LLC

Denver, Colorado, 80209, United States

Location

Dupont Circle Physician's Group

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

Location

Whitman-Walker Clinic

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

Location

Capital Medical Associates, PC

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

Location

Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33311, United States

Location

Gary J. Richmond, M.D., P.A.

Fort Lauderdale, Florida, 33316, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

The Kinder Medical Group

Miami, Florida, 33133, United States

Location

Wohlfeiler, Piperato and Associates, LLC

Miami Beach, Florida, 33139, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Valuhealthmd,Llc / Idocf

Orlando, Florida, 32806, United States

Location

Infectious Disease Associates of NW FL

Pensacola, Florida, 32504, United States

Location

AHF Health Positive - Tampa Bay

Safety Harbor, Florida, 34695, United States

Location

St. Joseph's Hospital d/b/a Comprehensive Research Institute

Tampa, Florida, 33614, United States

Location

Emory University

Atlanta, Georgia, 30306, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Atlanta ID Group

Atlanta, Georgia, 30309, United States

Location

Infectious Disease Specialists of America

Decatur, Georgia, 30033, United States

Location

Mercer University School of Medicine

Macon, Georgia, 31201, United States

Location

Clint Spencer Clinic

Honolulu, Hawaii, 96813, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Howard Brown Health Center

Chicago, Illinois, 60613, United States

Location

Northstar Medical Center

Chicago, Illinois, 60657, United States

Location

Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station

Lutherville, Maryland, 21093, United States

Location

Community Research Initiative of New England

Boston, Massachusetts, 02111, United States

Location

Claudia T Martorell, MD., LLC dba The Research Institute

Springfield, Massachusetts, 01105, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Central West Clinical Research, Inc.

St Louis, Missouri, 63108, United States

Location

Southampton Healthcare

St Louis, Missouri, 63139, 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

Southwest Care Center

Sante Fe, New Mexico, 87505, United States

Location

Upstate Infectious Disease Associates

Albany, New York, 12208, United States

Location

New York Hospital Queens

Flushing, New York, 11355, United States

Location

North Shore University Hospital--Division of Infectious Diseases

Manhasset, New York, 11030, United States

Location

Greiger Clinic

Mount Vernon, New York, 10550, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Ricky K. Hsu, Md, Pc

New York, New York, 10011, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Clinical and Translational Research Center - UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28207, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27834, United States

Location

Rosedale Infectious Diseases

Huntersville, North Carolina, 28078, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Summa Health System Care Center

Akron, Ohio, 44203, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia FIGHT

Philadelphia, Pennsylvania, 19107, United States

Location

University of South Carolina

Columbia, South Carolina, 29223, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Trinity Health and Wellness Center

Dallas, Texas, 75208, United States

Location

Southwest Infectious Disease Associates, Inc.

Dallas, Texas, 75219, United States

Location

Tarrant County Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

Garcia Family Health Group

Harlingen, Texas, 78550, United States

Location

Therapeutic Concepts, P.A.

Houston, Texas, 77004, United States

Location

Gordon E. Crofoot MD PA

Houston, Texas, 77098, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

CARE-ID

Annandale, Virginia, 22003, United States

Location

Peter Shalit, M.D.

Seattle, Washington, 98104, United States

Location

Rockwood Pulmonary and Critical Care

Spokane, Washington, 99204, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 02010, Australia

Location

St Vincent's Hospital, Sydney

Darlinghurst, 02010, Australia

Location

Taylor Square Private Clinic

Darlinghurst, 02010, Australia

Location

Northside Clinic

Fitzroy North, 03068, Australia

Location

Clinical Research - Infectious Diseases Unit Alfred Hospital

Melbourne, 03004, Australia

Location

Prahran Market Clinic

Prahran, 03181, Australia

Location

Albion Street Centre

Surry Hills, 02010, Australia

Location

East Sydney Doctors

Sydney, 02010, Australia

Location

LKH Medical University Graz West, Department of Internal Medicine

Graz, A-8020, Austria

Location

Universitätsklinikum Innsbruck Universitätsklinik für Dermatologie und Venerologie

Innsbruck, A6020, Austria

Location

Department of Dermatology, Allergy, and Infectious Disease University Vienna Medical School

Vienna, 01090, Austria

Location

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

Cliniques Universitaires Saint-Luc - UCL

Brussels, 01200, Belgium

Location

University Hospitals Leuven

Leuven, 03000, Belgium

Location

Division of HIV/AIDS, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Vancouver ID Research and Care Centre Society

Vancouver, British Columbia, V6Z2C7, Canada

Location

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Maple Leaf Research Maple Leaf Medical Clinic

Toronto, Ontario, M5G 1K2, Canada

Location

University Health Network/Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Clinique médicale L' Actuel

Montreal, Quebec, H2L 4P9, Canada

Location

McGill University Health Center, Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

Hopital Raymond Poincare

Garches, 92380, France

Location

Hôpital de la Croix-Rousse

Lyon, 69288, France

Location

Chu Hotel Dieu

Nantes, 44093, France

Location

CHU Nice - Archet 1

Nice, 06200, France

Location

Hopital Bichat Claude Bernard

Paris, 75018, France

Location

HOSPITAL SAINT LOUIS - Services des Maladies Infectieuses

Paris, 75475, France

Location

Hopital Saint Antoine- Service Maladies infectieuses

Paris, 75571, France

Location

Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses

Paris, 75651, France

Location

Hopital Tenon Service des Maladies infectieuses et tropicales

Paris, 75970, France

Location

Centre Hospitalier de Tourcoing

Tourcoing, 59208, France

Location

EPIMED GmbH

Berlin, 12157, Germany

Location

Medizinische Universitätsklinik I der Friedrich-Wilhelms Universität Bonn

Bonn, 53105, Germany

Location

Department of Dermatology University Hospital Essen

Essen, 45122, Germany

Location

Private Practice Gute & Locher & Lutz, Infektiologikum

Frankfurt am Main, 60311, Germany

Location

Division of Infectious Disease, Department of Medicine, University Hospital Freiburg

Freiburg im Breisgau, 79106, Germany

Location

ICH Study Center

Hamburg, 20146, Germany

Location

Universitätsklinikum Eppendorf Ambulanzzentrum des UKE GmbH, Infekiologie

Hamburg, 20246, Germany

Location

MUC Research GmbH

München, 80335, Germany

Location

Ospedali Riuniti

Bergamo, 24128, Italy

Location

IRCCS Ospedale San Raffaele Centro San Luigi, Unità Operativa di Malattie Infettive

Milan, 20127, Italy

Location

I Div Infectious Diseases, Luigi Sacco Hospital

Milan, 20157, Italy

Location

San Gerardo Hospital - Uo Malattie Infettive

Monza, 20092, Italy

Location

Foundation "IRCCS Policlinico San Matteo Hospital"

Pavia, 27100, Italy

Location

National Institute for Infectious Diseases "L. Spallanzani" IRCCS

Rome, 00149, Italy

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 AC, Netherlands

Location

Erasmus MC

Rotterdam, PB 2040, Netherlands

Location

Hospital de Santa Maria - CHLN, EPE

Lisbon, 1649-035, Portugal

Location

Serviço de Doenças Infecciosas, Hospital S. Joao

Porto, 4200-319, Portugal

Location

Hospital de Joaquim urbano

Porto, 4369-004, Portugal

Location

Clinical Research Puerto Rico

San Juan, 00909, Puerto Rico

Location

Hospital General Universitario Alicante

Alicante, 03010, Spain

Location

Hospital Universitari de Bellvitge

Cataluña, 08907, Spain

Location

Hospital Universitario de Elche, Unidad de Enfermedades Infecciosas

Elche, 03202, Spain

Location

Hospital Universitario 12 Octubre

Madrid, 28041, Spain

Location

Unidad HIV. Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Universitätsklinik für Infektiologie

Bern, 03010, Switzerland

Location

CHUV

Lausanne, 01011, Switzerland

Location

University Hospital Zurich

Zurich, 08091, Switzerland

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Ridu, Wgh

Edinburgh, EH42XU, United Kingdom

Location

Clinical Research, Grahame Hayton Unit Ambrose King Centre, The Royal London Hospital

London, E11 BB, United Kingdom

Location

Royal Free NHS Trust,

London, NW32QG, United Kingdom

Location

Guys and St Thomas' NHS trust

London, SE7 4EH, United Kingdom

Location

Chelsea and Westminster Hospital

London, Sw10 9NH, United Kingdom

Location

North Manchester General Hospital

Manchester, M8 5RB, United Kingdom

Location

MeSH Terms

Interventions

Emtricitabine, Rilpivirine, Tenofovir Drug Combination; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Rilpivirine; Nitriles; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Oxazines

Results Point of Contact

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

ClinicalTrialDisclosures@gilead.com

Study Officials

• Todd Fralich, M.D.

  Gilead Sciences

  STUDY CHAIR

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: March 3, 2011
• First Posted: March 7, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2014
• Last Updated: February 25, 2015
• Results First Posted: November 27, 2013

Record last verified: 2015-02

Locations

CH (3); GB (7); AU (3); BE (3); US (83); FR (10); NL (2); PT (3); PR (1); DE (8); IT (6); ES (6); CA (8)