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Acquired Immunodeficiency SyndromePhase 3NCT01475838

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

A Phase 3 study testing PI, RTV and FTC/TDF in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 99 sites in 12 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

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PI, RTV and FTC/TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
99 sitesin 12 countries
Study dates
Nov 2011to Dec 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
  • 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
Show all 16Show fewer
  • 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
  • Age ≥ 18 years

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

99 sites in 12 countries.

99 sites in 12 countries

United States45 sites

  • Atlanta ID Group

    Atlanta, Georgia, 30309

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AIDS Healthcare Foundation

    Beverly Hills, California, 90211

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • ID Consultants, P.A.

    Charlotte, North Carolina, 28209

  • Northwestern University Division of Infectious Diseases

    Chicago, Illinois, 60611

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

    Chicago, Illinois, 60612

  • Uptown Physicians Group

    Dallas, Texas, 75204

  • Southwest Infectious Disease Clinical Research, Inc

    Dallas, Texas, 75219

  • Gary Richmond, MD

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida, 34982

  • Kaiser Permanente

    Hayward, California, 94545

  • I.D. Care Associates PA

    Hillsborough, New Jersey, 08844

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Gordon Crofoot Md, Pa

    Houston, Texas, 77098

  • St. Hope Foundation Inc

    Houston, Texas, 77401

  • The Kansas City Free Health Clinic

    Kansas City, Missouri, 64111

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Peter J. Ruane, M.D., Inc.

    Los Angeles, California, 90036

  • OASIS Clinic

    Los Angeles, California, 90043

  • Anthony Mills MD Inc

    Los Angeles, California, 90069

  • The Kinder Medical Group

    Miami, Florida, 33133

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Greiger Clinic

    Mount Vernon, New York, 10550

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Idocf/Valuhealthmd, Llc

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94304

  • Infectious Diseases Associates of NW FL, P.A.

    Pensacola, Florida, 32504

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • Pueblo Family Physicians

    Phoenix, Arizona, 85015

  • University of California, Davis

    Sacramento, California, 95817

  • Kaiser Permanente

    Sacramento, California, 95841

  • AHF Health Positive Tampa Bay

    Safety Harbor, Florida, 34695

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Metropolis Medical

    San Francisco, California, 94109

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • St. Joseph's Comprehensive Research Institute

    Tampa, Florida, 33614

  • Dupont Circle Physicians Group, P.C

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, PC

    Washington D.C., District of Columbia, 20036

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

France10 sites

  • CHU de Besancon, Hopital Saint-Jacques

    Besançon, 25030

  • Hôpital de la Croix-Rousse

    Lyon, 69317

  • CHU Hôpital Gui de Chauliac

    Montpellier, 34295

  • Archet 1 Chu Nice Department of Infectology

    Nice, 06202

  • Saint-Louis Hospital

    Paris, 75010

  • Hopital Saint Antoine

    Paris, 75012

  • Hôpital Bichat-Claude Bernard

    Paris, 75018

  • hôpital Tenon

    Paris, 75020

  • Maladies Infectieuses Dpt

    Paris, 75651

  • Hôpital Haut Lévêque

    Pessac, 33604

Other trials in France

Germany9 sites

  • Epimed GmbH

    Berlin, 12157

  • University of Bonn

    Bonn, 53127

  • Infektlonsambulanz Unlkllnik Koln

    Cologne, 50937

  • Universitätsklinikum Essen, Dermatologie, HIV Ambulanz

    Essen, 45147

  • Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68

    Frankfurt, 60590

  • ICH Study Center

    Hamburg, 20146

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

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen

    Munich, 80336

Other trials in Germany

Spain9 sites

  • Hospital General Universitario Alicante

    Alicante, 03010

  • Hospital clinic

    Barcelona, 08036

  • Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.

    Barcelona, 08907

  • Hospital Germans Trias I Pujol

    Barcelona, 08916

  • Hospital General Universitario de Elche

    Elche, Alicante, 03202

  • Infectious Diseases Department, Hospital Carlos III

    Madrid, 28029

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital La Paz

    Madrid, 28760

  • Hospital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Italy6 sites

  • Ospedali Riuniti

    Bergamo, 24128

  • Fondazione Centro San Raffaele

    Milan, 20127

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

    Milan, 20142

  • Ospedale Luigi Sacco

    Milan, 20157

  • National Institute for Infectious Diseases "L. Spallanzani"

    Rome, 00149

  • University of Torino, Dept of Infectious Disease

    Torino, 10122

Other trials in Italy

Austria4 sites

  • Innsbruck Medical University

    Innsbruck, A 6020

  • Univ.-Kklinik fuer Innere Medizin III

    Salzburg, 5020

  • Medical University of Vienna

    Vienna, 1090

  • Otto-Wagner-Spital

    Vienna, 1140

Other trials in Austria

Belgium3 sites

  • UCL Saint Luc

    Brussels, 01200

  • University Hospital Ghent

    Ghent, 9000

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

Portugal3 sites

  • HHP Hospital de Cascais

    Alcabideche, 2755

  • Hospital de Santa Maria-CHLN, EPE

    Lisbon, 1049-035

  • Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa

    Lisbon, 1150-069

Other trials in Portugal

Switzerland3 sites

  • Geneva University Hospital

    Geneva, 1205

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

    Zurich, 8091

  • Zentrum fur Infektionskrankheiten

    Zurich, CH-8038

Other trials in Switzerland

United Kingdom3 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN21ES

  • Royal Free Hampstead NHS Trust

    London, NW32QG

  • Chelsea and Westminster

    London, SW109NH

Other trials in United Kingdom

Canada2 sites

  • Clinique Medicale Du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Puerto Rico2 sites

  • Clinical Research Puert Rico

    San Juan, 00909

  • University of Puerto Rico School of Medicine

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 3b Randomized, Open-Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

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.

Being tested
PI, RTV, FTC/TDF, Stribild
Keywords
HIV-1, HIV, Treatment Experienced
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

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

  • PIDrug

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

  • RTVDrug

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

  • FTC/TDFDrug

    Also called Truvada

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

  • StribildDrug

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

Study groups in NCT01475838
Study groupRoleWhat they receive
StribildExperimentalParticipants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase.
Receives: Drug: Stribild
PI+RTV+FTC/TDFActive comparatorParticipants 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.
Receives: Drug: PI; Drug: RTV; Drug: FTC/TDF; Drug: Stribild

What is being measured

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

  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.

    Measured: Week 48

Secondary outcomes (3)

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

    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.

    Measured: Week 96

  2. Change From Baseline in CD4+ Cell Count at Week 48

    Measured: Baseline; Week 48

  3. Change From Baseline in CD4+ Cell Count at Week 96

    Measured: Baseline; Week 96

Timeline

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

  1. First posted21 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2013
  4. Study completionDec 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
None (open label)
Enrolment
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01475838
Sponsor's protocol ID
GS-US-236-0115
Other IDs
2011-004483-30
Status last verified
May 2016
First submitted
17 Nov 2011
Last updated
8 Jun 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 24908551

  • 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.

    PubMed 24908550

  • 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.

    PubMed 28555519

  • 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.

    PubMed 26286337

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PI, RTV and FTC/TDF in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 99 sites in 12 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 16 inclusion and 15 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 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, France, Germany, Spain, Italy and 7 more countries. 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 26 Jan 2015). 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?

Percentage of Participants With HIV-1 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 NCT01475838, which also lists 4 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 8 Jun 2016.

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