Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

HIV Infections Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095796
• Other study ID #: GS-US-236-0102
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2010
• Last updated: October 15, 2015
• Start date: March 2010
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: September 2014
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures

• Plasma HIV-1 RNA levels = 5,000 copies/mL

• No prior use of any approved or investigational antiretroviral drug for any length of time

• Screening genotype report must show sensitivity to FTC, TDF, and EFV

• Normal electrocardiogram (ECG)

• Adequate renal function (estimated glomerular filtration rate = 70 mL/min according to the Cockcroft Gault formula)

• Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) = 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

• Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug

• Age = 18 years

• Life expectancy = 1 year

Exclusion Criteria:

• A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening

• Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C

• Subjects experiencing decompensated cirrhosis

• Females who are breastfeeding

• Positive serum pregnancy test (female of childbearing potential)

• Implanted defibrillator or pacemaker

• Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance

• 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 (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline

• Medications contraindicated for use with EVG, COBI, FTC, EFV, or TDF; or subjects with any known allergies to the excipients of Stribild or Atripla tablets

• Participation in any other clinical trial without prior approval

• Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Intervention

Drug:
• Stribild
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily
• Atripla
Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime
• Stribild Placebo
Placebo to match Stribild STR administered orally once daily
• Atripla Placebo
Placebo to match Atripla tablet administered orally once daily prior to bedtime

Locations

Country	Name	City	State
Puerto Rico	Instituto de Investigacion Clentifica del Sur	Ponce
Puerto Rico	Clinical Research Puerto Rico	San Juan
Puerto Rico	HOPE Clinical Research	San Juan
Puerto Rico	University of Puerto Rico, School of Medicine, Proyecto ACTU	San Juan
Puerto Rico	VA Caribbean Healthcare System	San Juan
United States	Summa Health System	Akron	Ohio
United States	Upstate ID Association	Albany	New York
United States	Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)	Annandale	Virginia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Atlanta ID Group, PC	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Be Well Medical Center	Berkley	Michigan
United States	AHF Research Center	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Community Research Initiative	Boston	Massachusetts
United States	Jacobi Medical Center	Bronx	New York
United States	Montefiore Medical Center - AIDS Center	Bronx	New York
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Clinical and Translational Research Center	Chapel Hill	North Carolina
United States	Carolinas Medical Center-Myers Park	Charlotte	North Carolina
United States	Howard Brown Health Center	Chicago	Illinois
United States	Ruth M. Rothstein CORE Center	Chicago	Illinois
United States	University of South Carolina	Columbia	South Carolina
United States	Peabody Health Center	Dallas	Texas
United States	Southwest Infectious Disease Clinical Research, Inc.	Dallas	Texas
United States	Infectious Disease Specialists of Atlanta	Decatur	Georgia
United States	Apex Research, LLC	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	New York Hospital Queens	Flushing	New York
United States	Broward Health/Comprehensive Care Center	Fort Lauderdale	Florida
United States	Gary J. Richmond, MD, PA	Fort Lauderdale	Florida
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	Midway Immunology and Research Center	Fort Pierce	Florida
United States	Tarrant County Infectious Disease Associates	Fort Worth	Texas
United States	East Carolina University	Greenville	North Carolina
United States	Valley AIDS Council	Harlingen	Texas
United States	Kaiser Permanente Hospital	Hayward	California
United States	ID Care	Hillsborough	New Jersey
United States	Leahi Hospital	Honolulu	Hawaii
United States	Gordon E. Crofoot MD PA	Houston	Texas
United States	Research Access Network	Houston	Texas
United States	Therapeutic Concepts	Houston	Texas
United States	Rosedale Infectious Diseases	Huntersville	North Carolina
United States	Health for Life Clinic PLLC	Little Rock	Arkansas
United States	Living Hope Clinical Foundation	Long Beach	California
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Anthony Mills, MD, Inc.	Los Angeles	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Kaiser Permanente	Los Angeles	California
United States	Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic	Los Angeles	California
United States	Peter J. Ruane, MD, Inc.	Los Angeles	California
United States	UCLA Center for Clinical Aids Research and Education	Los Angeles	California
United States	Mercer University School of Medicine	Macon	Georgia
United States	North Shore University Hospital	Manhasset	New York
United States	The Kinder Medical Group	Miami	Florida
United States	University of Miami School of Medicine	Miami	Florida
United States	Wohlfeiler, Piperato and Associates, LLC	Miami Beach	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Greiger Clinic	Mount Vernon	New York
United States	Yale University HIV Clinical Trials Program	New Haven	Connecticut
United States	Beth Israel Medical Center	New York	New York
United States	Chelsea Village Medical, PC	New York	New York
United States	Ricky K. Hsu, MD, PC	New York	New York
United States	The Aaron Diamond AIDS Research Center	New York	New York
United States	Saint Michaels Medical Center	Newark	New Jersey
United States	Orange Coast Medical Group	Newport Beach	California
United States	Alameda County Medical Center	Oakland	California
United States	East Bay AIDS Center	Oakland	California
United States	Idocf/ Valuhealthmd, Llc	Orlando	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Stanford University	Palo Alto	California
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Spectrum Medical Group	Phoenix	Arizona
United States	Kaiser Permanente Medical Group	Sacramento	California
United States	La Playa Medical Group and Clinical Research	San Diego	California
United States	Kaiser Permanente Medical Center, Clinical Trials Unit	San Francisco	California
United States	Metropolis Medical	San Francisco	California
United States	San Francisco General Hospital, University of California, San Francisco	San Francisco	California
United States	SouthWest CARE Center	Sante Fe	New Mexico
United States	Peter Shalit, MD	Seattle	Washington
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	Rockwood Pulmonary and Critical Care	Spokane	Washington
United States	Baystate Infectious Diseases Clinical Research	Springfield	Massachusetts
United States	The Research Institute	Springfield	Massachusetts
United States	Central West Clinical Research	St. Louis	Missouri
United States	Southampton Healthcare	St. Louis	Missouri
United States	The Stamford Hospital	Stamford	Connecticut
United States	Infectious Disease Research Institute Inc.	Tampa	Florida
United States	St. Joseph's Comprehensive Research Institute	Tampa	Florida
United States	University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department	Tampa	Florida
United States	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida
United States	Garden State Infectious Diseases Associates, PA	Voorhees	New Jersey
United States	Capital Medical Associates, PC	Washington	District of Columbia
United States	Dupont Circle Physicians Group	Washington	District of Columbia
United States	George Washington University Medical Faculty Associates	Washington	District of Columbia
United States	Whitman-Walker Clinic	Washington	District of Columbia
United States	Wake Forest University Health Sciences	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

Sax PE, DeJesus E, Mills A, Zolopa A, Cohen C, Wohl D, Gallant JE, Liu HC, Zhong L, Yale K, White K, Kearney BP, Szwarcberg J, Quirk E, Cheng AK; GS-US-236-0102 study team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-for — View Citation

Wohl DA, Cohen C, Gallant JE, Mills A, Sax PE, Dejesus E, Zolopa A, Liu HC, Plummer A, White KL, Cheng AK, Rhee MS, Szwarcberg J; GS-US-236-0102 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabi — View Citation

Zolopa A, Sax PE, DeJesus E, Mills A, Cohen C, Wohl D, Gallant JE, Liu HC, Plummer A, White KL, Cheng AK, Rhee MS, Szwarcberg J; GS-US-236-0102 Study Team. A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48		Week 48	No
Secondary	The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96		Week 96	No
Secondary	The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144		Week 144	No
Secondary	The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192		Week 192	No
Secondary	The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm		Week 48	No
Secondary	The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192	Change = value of the relevant time point minus the baseline value	Baseline; Weeks 48, 96, 144, and 192	No
Secondary	The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48		Week 48	No