AzTrials
AzTrials

HIVPhase 3NCT01095796

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

A Phase 3 study testing Stribild and Atripla in people with HIV and HIV Infections, run by Gilead Sciences at 102 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, HIV Infections
What is being tested?
Stribild and Atripla
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
707 participants
Where
102 sitesin 2 countries
Study dates
Mar 2010to Sep 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

102 sites in 2 countries.

102 sites in 2 countries

United States97 sites

  • Summa Health System

    Akron, Ohio, 44304

  • Upstate ID Association

    Albany, New York, 12208

  • Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Emory University

    Atlanta, Georgia, 30308

  • Atlanta ID Group, PC

    Atlanta, Georgia, 30309

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AHF Research Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Community Research Initiative

    Boston, Massachusetts, 02215

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Clinical and Translational Research Center

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center-Myers Park

    Charlotte, North Carolina, 28207

  • Ruth M. Rothstein CORE Center

    Chicago, Illinois, 60612

  • Howard Brown Health Center

    Chicago, Illinois, 60613

  • University of South Carolina

    Columbia, South Carolina, 29203

  • Southwest Infectious Disease Clinical Research, Inc.

    Dallas, Texas, 75204

  • Peabody Health Center

    Dallas, Texas, 75215

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Apex Research, LLC

    Denver, Colorado, 80209

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • New York Hospital Queens

    Flushing, New York, 11355

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Broward Health/Comprehensive Care Center

    Fort Lauderdale, Florida, 33311

  • Gary J. Richmond, MD, PA

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • East Carolina University

    Greenville, North Carolina, 27834

  • Valley AIDS Council

    Harlingen, Texas, 78550

  • Kaiser Permanente Hospital

    Hayward, California, 94545

  • ID Care

    Hillsborough, New Jersey, 08844

  • Leahi Hospital

    Honolulu, Hawaii, 96816

  • Therapeutic Concepts

    Houston, Texas, 77004

  • Gordon E. Crofoot MD PA

    Houston, Texas, 77098

  • Research Access Network

    Houston, Texas, 77098

  • Rosedale Infectious Diseases

    Huntersville, North Carolina, 28078

  • Health for Life Clinic PLLC

    Little Rock, Arkansas, 72207

  • Living Hope Clinical Foundation

    Long Beach, California, 90813

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic

    Los Angeles, California, 90028

  • UCLA Center for Clinical Aids Research and Education

    Los Angeles, California, 90035

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Anthony Mills, MD, Inc.

    Los Angeles, California, 90069

  • Mercer University School of Medicine

    Macon, Georgia, 31210

  • North Shore University Hospital

    Manhasset, New York, 11030

  • The Kinder Medical Group

    Miami, Florida, 33133

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Wohlfeiler, Piperato and Associates, LLC

    Miami Beach, Florida, 33139

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Greiger Clinic

    Mount Vernon, New York, 10550

  • Yale University HIV Clinical Trials Program

    New Haven, Connecticut, 06033

  • Beth Israel Medical Center

    New York, New York, 10003

  • Chelsea Village Medical, PC

    New York, New York, 10011

  • Ricky K. Hsu, MD, PC

    New York, New York, 10011

  • The Aaron Diamond AIDS Research Center

    New York, New York, 10016

  • Saint Michaels Medical Center

    Newark, New Jersey, 07102

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • Alameda County Medical Center

    Oakland, California, 94602

  • East Bay AIDS Center

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Idocf/ Valuhealthmd, Llc

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94303

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • San Francisco General Hospital, University of California, San Francisco

    San Francisco, California, 94110

  • Metropolis Medical

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center, Clinical Trials Unit

    San Francisco, California, 94118

  • SouthWest CARE Center

    Sante Fe, New Mexico, 87505

  • Peter Shalit, MD

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Rockwood Pulmonary and Critical Care

    Spokane, Washington, 99204

  • The Research Institute

    Springfield, Massachusetts, 01107

  • Baystate Infectious Diseases Clinical Research

    Springfield, Massachusetts, 01199

  • Central West Clinical Research

    St Louis, Missouri, 63108

  • Southampton Healthcare

    St Louis, Missouri, 63139

  • The Stamford Hospital

    Stamford, Connecticut, 06902

  • University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

    Tampa, Florida, 33602

  • Infectious Disease Research Institute Inc.

    Tampa, Florida, 33614

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33615

  • Montefiore Medical Center - AIDS Center

    The Bronx, New York, 10467

  • Jacobi Medical Center

    The Bronx, New York, 31210

  • Treasure Coast Infectious Disease Consultants

    Vero Beach, Florida, 32960

  • Garden State Infectious Diseases Associates, PA

    Voorhees Township, New Jersey, 08043

  • Dupont Circle Physicians Group

    Washington D.C., District of Columbia, 20009

  • Whitman-Walker Clinic

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, PC

    Washington D.C., District of Columbia, 20036

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Puerto Rico5 sites

  • Instituto de Investigacion Clentifica del Sur

    Ponce, 00731

  • Clinical Research Puerto Rico

    San Juan, 00909

  • HOPE Clinical Research

    San Juan, 00909

  • VA Caribbean Healthcare System

    San Juan, 00921

  • University of Puerto Rico, School of Medicine, Proyecto ACTU

    San Juan, 00935

Other trials in Puerto Rico

About this study

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

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.

Conditions
HIV, HIV Infections
Being tested
Stribild, Atripla, Stribild Placebo, Atripla Placebo
Keywords
Treatment Naive, HIV 1 Infected
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StribildDrug

    Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily

  • AtriplaDrug

    Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime

  • Stribild PlaceboDrug

    Placebo to match Stribild STR administered orally once daily

  • Atripla PlaceboDrug

    Placebo to match Atripla tablet administered orally once daily prior to bedtime

Study groups in NCT01095796
Study groupRoleWhat they receive
StribildExperimentalStribild plus placebo to match Atripla
Receives: Drug: Stribild; Drug: Atripla Placebo
AtriplaActive comparatorAtripla plus placebo to match Stribild
Receives: Drug: Atripla; Drug: Stribild Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 48

Secondary outcomes (6)

  1. 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

    Measured: Week 96

  2. 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

    Measured: Week 144

  3. 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

    Measured: Week 192

  4. 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

    Measured: Week 48

  5. 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

    Measured: Baseline; Weeks 48, 96, 144, and 192

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

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionAug 2011
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01095796
Sponsor's protocol ID
GS-US-236-0102
Status last verified
Oct 2015
First submitted
17 Mar 2010
Last updated
11 Nov 2015
Data monitoring committee
Yes

Publications

  • 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-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012 Jun 30;379(9835):2439-2448. doi: 10.1016/S0140-6736(12)60917-9.

    PubMed 22748591

  • 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/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 May 1;63(1):96-100. doi: 10.1097/QAI.0b013e318289545c.

    PubMed 23392460

  • 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/emtricitabine/tenofovir DF versus single-tablet regimen efavirenz/emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):e118-20. doi: 10.1097/QAI.0000000000000057. No abstract available.

    PubMed 24256630

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stribild and Atripla in people with HIV and HIV Infections, run by Gilead Sciences at 102 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01095796, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in