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Acquired Immunodeficiency SyndromePhase 3NCT01495702

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

A Phase 3 study testing NNRTI, FTC/TDF and Stribild in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 80 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 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NNRTI, FTC/TDF and Stribild
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
439 participants
Where
80 sitesin 12 countries
Study dates
Dec 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 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
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  • 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.
  • Age ≥ 18 years

Who cannot join

  • 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
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 (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

Trial locations and contacts

80 sites in 12 countries.

80 sites in 12 countries

United States39 sites

  • Clinical Alliance for Research & Education - Infectious Disease

    Annandale, Virginia, 22003

  • Atlanta ID Group, PC

    Atlanta, Georgia, 30309

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • AHF Research Center

    Beverly Hills, California, 90211

  • Pacific Oak Medical Group

    Beverly Hills, California, 90211

  • ID Consultants, P.A.

    Charlotte, North Carolina, 28209

  • Southwest Infectious Disease Clinical Researach Inc

    Dallas, Texas, 75219

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Gary Richmond MD, PA, Inc

    Fort Lauderdale, Florida, 33316

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research

    Ft. Pierce, Florida, 34982

  • Kaiser Permanente

    Hayward, California, 94545

  • ID Care

    Hillsborough, New Jersey, 08844

  • Therapeutic Concepts PA

    Houston, Texas, 77004

  • Gordon E. Crofoot MD, PA

    Houston, Texas, 77098

  • The Kansas City Free Health Clinic

    Kansas City, Missouri, 64111

  • Peter J. Ruane, MD, Inc.

    Los Angeles, California, 90036

  • OASIS Clinic

    Los Angeles, California, 90059

  • Anthony Mills MD Inc

    Los Angeles, California, 90069

  • The Kinder Medical Group

    Miami, Florida, 33133

  • HIV Program Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Greiger Clinic

    Mount Vernon, New York, 10550

  • Aaron Diamond AIDS Research Center

    New York, New York, 10016

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Alameda County Medical Center

    Oakland, California, 94602

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • ValuHealth MD, LLC

    Orlando, Florida, 32806

  • Infectious Diseases Associates of Northwest Florida

    Pensacola, Florida, 32504

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Spectrum Medical Group

    Phoenix, Arizona, 85012

  • Kaiser Permanente Medical Group

    Sacramento, California, 95825

  • Health Positive

    Safety Harbor, Florida, 34684

  • La Playa Medical Group and Clinical Research

    San Diego, California, 92103

  • Metropolis Medical

    San Francisco, California, 94109

  • Kaiser Permanente

    San Francisco, California, 94118

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Dupont Circle Physicians Group, P.C.

    Washington D.C., District of Columbia, 20009

  • Capital Medical Associates, P.C.

    Washington D.C., District of Columbia, 20036

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany7 sites

  • EPIMED GmbH

    Berlin, 12157

  • MIB Dienstleistung GmbH

    Berlin, 13353

  • Medizinische Universitätsklinik

    Bonn, 53127

  • Infektiologikum

    Frankfurt, 60596

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • ICH Study Center

    Hamburg, 20146

  • MUC Research GmbH

    München, 80335

Other trials in Germany

United Kingdom6 sites

  • Brighton and Sussex University Hospitals NHS Trust

    Brighton, BN2 1ES

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Homerton University Hospital

    London, E9 6SR

  • South London Healthcare NHS Trust

    London, SE1 1EE

  • St. Thomas' Hospital

    London, SE17EH

  • Chelsea & Westminster Hospital

    London, SW10 9TH

Other trials in United Kingdom

France5 sites

  • CHU de Besancon - Hopital Saint-Jacques

    Besançon, 25030

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33079

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Bichat Claude Bernard

    Paris, 75018

  • Hopital Saint Antoine

    Paris, 75571

Other trials in France

Italy5 sites

  • Azienda Ospedaliera Ospedale di Circolo Busto Arsizio

    Busto Arsizio/Varese, 21052

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20127

  • Ospedale Luigi Sacco

    Milan, 20157

  • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

    Roma, 00149

  • Policlinico Universitario Agostino Gemelli

    Rome, 1214

Other trials in Italy

Spain5 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08025

  • Hospital del Mar

    Barcelona, 8003

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Galicia, 15706

  • Hospital La Fe de Valencia

    Valencia, 46009

Other trials in Spain

Australia3 sites

  • Holdsworth House Medical Practice

    Darlinghurst, NSW 2010

  • Prahran Market Clinic

    South Yarra, VIC 3141

  • East Sydney Doctors

    Sydney, NSW 2010

Other trials in Australia

Belgium3 sites

  • SEAMEO Regional Centre for Tropical Medicine

    Antwerp, 2000

  • Hôpitaux IRIS Sud

    Brussels, 1050

  • University Hospital of Leuven

    Leuven, 3000

Other trials in Belgium

Canada3 sites

  • Clinique Medicale Du Quartier Latin

    Montreal, Quebec, H2L 5B1

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • Maple Leaf Medical Clinic

    Toronto, Ontario, M5B1L6

Other trials in Canada

Austria2 sites

  • Medical University of Vienna

    Vienna, 1090

  • Otto Wagner Spital

    Vienna, 1140

Other trials in Austria

Portugal1 site

  • Hospital de Santa Maria - CHLN EPE

    Lisbon, 1649-035

Other trials in Portugal

Puerto Rico1 site

  • Clinical Research Puerto Rico Inc

    San Juan, Puerto Rica, 00909

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 Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (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 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.

Being tested
NNRTI, 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.

  • NNRTIDrug

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

  • FTC/TDFDrug

    Also called Truvada

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

  • StribildDrug

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

Study groups in NCT01495702
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
NNRTI+FTC/TDFActive comparatorParticipants 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.
Receives: Drug: NNRTI; 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 posted20 Dec 2011 (estimated)
  2. Study startDec 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
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01495702
Sponsor's protocol ID
GS-US-236-0121
Other IDs
2011-004963-56
Status last verified
Dec 2015
First submitted
14 Dec 2011
Last updated
7 Jan 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 28689453

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NNRTI, FTC/TDF and Stribild in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 80 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Germany, United Kingdom, France, 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 NCT01495702, which also lists 2 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 7 Jan 2016.

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