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

December 1, 2015 updated by: Gilead Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
439

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia, NSW 2010
        • Holdsworth House Medical Practice
      • South Yarra, Australia, VIC 3141
        • Prahran Market Clinic
      • Sydney, Australia, NSW 2010
        • East Sydney Doctors
  • Austria
      • Wien, Austria, 1090
        • Medical University of Vienna
      • Wien, Austria, 1140
        • Otto Wagner Spital
  • Belgium
      • Antwerpen, Belgium, 2000
        • SEAMEO Regional Centre for Tropical Medicine
      • Bruxelles, Belgium, 1050
        • Hôpitaux IRIS Sud
      • Leuven, Belgium, 3000
        • University Hospital of Leuven
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Center
      • Toronto, Ontario, Canada, M5B1L6
        • Maple Leaf Medical Clinic
    • Quebec
      • Montreal, Quebec, Canada, H2L 5B1
        • Clinique Medicale du Quartier Latin
  • France
      • Besancon, France, 25030
        • CHU de Besancon - Hopital Saint-Jacques
      • Bordeaux, France, 33079
        • Groupe Hospitalier Pellegrin
      • Paris, France, 75010
        • Hôpital Saint Louis
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Paris, France, 75018
        • Hopital Bichat Claude Bernard
  • Germany
      • Berlin, Germany, 12157
        • Epimed GmbH
      • Berlin, Germany, 13353
        • MIB Dienstleistung GmbH
      • Bonn, Germany, 53127
        • Medizinische Universitätsklinik
      • Frankfurt, Germany, 60596
        • Infektiologikum
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Hamburg, Germany, 20146
        • ICH Study Center
      • München, Germany, 80335
        • MUC Research GmbH
  • Italy
      • Busto Arsizio/Varese, Italy, 21052
        • Azienda Ospedaliera Ospedale di Circolo Busto Arsizio
      • Milano, Italy, 20157
        • Ospedale Luigi Sacco
      • Milano, Italy, 20127
        • Fondazione Centro San Raffaele del Monte Tabor
      • Roma, Italy, 00149
        • Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
      • Rome, Italy, 1214
        • Policlinico Universitario Agostino Gemelli
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Hospital de Santa Maria - CHLN EPE
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico Inc
  • Spain
      • Barcelona, Spain, 8003
        • Hospital del Mar
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Valencia, Spain, 46009
        • Hospital La Fe de Valencia
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15706
        • Hospital Clinico Universitario de Santiago
  • United Kingdom
      • Brighton, United Kingdom, BN2 1ES
        • Brighton and Sussex University Hospitals NHS Trust
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • London, United Kingdom, SW10 9TH
        • Chelsea & Westminster Hospital
      • London, United Kingdom, E9 6SR
        • Homerton University Hospital
      • London, United Kingdom, SE1 1EE
        • South London Healthcare NHS Trust
      • London, United Kingdom, SE17EH
        • St. Thomas' Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Spectrum Medical Group
    • California
      • Beverly Hills, California, United States, 90211
        • AHF Research Center
      • Beverly Hills, California, United States, 90211
        • Pacific Oak Medical Group
      • Hayward, California, United States, 94545
        • Kaiser Permanente
      • Los Angeles, California, United States, 90036
        • Peter J. Ruane, MD, Inc.
      • Los Angeles, California, United States, 90069
        • Anthony Mills MD Inc
      • Los Angeles, California, United States, 90059
        • OASIS Clinic
      • Oakland, California, United States, 94602
        • Alameda County Medical Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Medical Group
      • San Diego, California, United States, 92103
        • La Playa Medical Group and Clinical Research
      • San Francisco, California, United States, 94118
        • Kaiser Permanente
      • San Francisco, California, United States, 94109
        • Metropolis Medical
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Dupont Circle Physicians Group, P.C.
      • Washington, District of Columbia, United States, 20036
        • Capital Medical Associates, P.C.
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond MD, PA, Inc
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology and Research
      • Miami, Florida, United States, 33133
        • The Kinder Medical Group
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Orlando, Florida, United States, 32806
        • ValuHealth MD, LLC
      • Pensacola, Florida, United States, 32504
        • Infectious Diseases Associates of Northwest Florida
      • Safety Harbor, Florida, United States, 34684
        • Health Positive
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta ID Group, PC
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialists of Atlanta
    • Michigan
      • Berkley, Michigan, United States, 48072
        • Be Well Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • HIV Program Hennepin County Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • The Kansas City Free Health Clinic
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center
      • Somers Point, New Jersey, United States, 08244
        • South Jersey Infectious Disease
    • New York
      • Mt. Vernon, New York, United States, 10550
        • Greiger Clinic
      • New York, New York, United States, 10016
        • Aaron Diamond AIDS Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • ID Consultants, P.A.
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • Texas
      • Dallas, Texas, United States, 75219
        • Southwest Infectious Disease Clinical Researach Inc
      • Fort Worth, Texas, United States, 76104
        • Tarrant County Infectious Disease Associates
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts PA
      • Houston, Texas, United States, 77098
        • Gordon E. Crofoot MD, PA
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Clinical Alliance for Research & Education - Infectious Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Stribild
Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase.
Drug: Stribild
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
ACTIVE_COMPARATOR: NNRTI+FTC/TDF
Participants 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.
Drug: FTC/TDF
FTC/TDF (200/300 mg) administered according to prescribing information
Other Names:
  • Truvada
Drug: Stribild
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
Drug: NNRTI
NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Time Frame: 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.
Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in CD4+ Cell Count at Week 48
Time Frame: Baseline; Week 48
Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 96
Time Frame: Baseline; Week 96
Baseline; Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Time Frame: 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.
Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Damian McColl, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-236-0121
  • 2011-004963-56 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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