Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

December 16, 2019 updated by: Gilead Sciences

A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

881

Phase

  • 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

  • Belgium
      • Brussels, Belgium
        • CHU Saint-Pierre University Hospital
      • Brussels, Belgium
        • Cliniques Universitaires Ucl Saint-Luc
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Spectrum Health
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Canada
        • University Health Network
      • Toronto, Ontario, Canada
        • Maple Leaf Research
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University Health Centre
      • Montreal, Quebec, Canada
        • Clinique Médicale L'Actuel
      • Montreal, Quebec, Canada
        • Clinique OPUS
  • France
      • Paris, France
        • Hopital Saint Louis
      • Paris, France
        • Hopital Bichat Claude Bernard
      • Tours, France
        • CHU Tours
  • Germany
      • Berlin, Germany
        • Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
      • Bonn, Germany
        • University of Bonn
      • Duesseldorf, Germany
        • Center for HIV and Hepatogastroenterology
      • Essen, Germany
        • Universitätsklinikum Essen
      • Frankfurt, Germany
        • Infektiologikum
      • Hamburg, Germany
        • ICH Study Center Hamburg
      • Hamburg, Germany
        • Universitaetsklinikum Hamburg-Eppendorf
      • Koln, Germany
        • Universität zu Köln
      • München, Germany
        • MUC Research GmbH
  • Puerto Rico
      • San Juan, Puerto Rico
        • Clinical Research Puerto Rico Inc
      • San Juan, Puerto Rico
        • Hope Clinical Research
      • San Juan, Puerto Rico
        • University of Puerto Rico School of Medicine
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Clinic I Provincial
      • Barcelona, Spain
        • Hospital Universitary de Bellvitge
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario La Paz
  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel
      • Genève, Switzerland
        • Geneva University Hospital
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
      • London, United Kingdom
        • Mortimer Market Centre
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • Barts & The London NHS Trust
      • London, United Kingdom
        • The Royal Free Hampstead NHS Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Maricopa Integrated Health System
      • Phoenix, Arizona, United States
        • Spectrum Medical Group
    • California
      • Beverly Hills, California, United States
        • AHF Research Center
      • Beverly Hills, California, United States
        • Pacific Oaks Medical Group
      • Long Beach, California, United States
        • Long Beach Education and Research Consultants
      • Los Angeles, California, United States
        • Tarrant County ID Associates
      • Los Angeles, California, United States
        • Kaiser Permanente
      • Los Angeles, California, United States
        • Southern California Men's Medical Group
      • Sacramento, California, United States
        • Kaiser Permanente
      • Sacramento, California, United States
        • University of California-UC Davis
      • San Diego, California, United States
        • La Playa Medical Group and Clinical Research
      • San Francisco, California, United States
        • Kaiser Permanente
      • San Francisco, California, United States
        • Optimus Medical
      • San Leandro, California, United States
        • Kaiser Permanente
      • Torrance, California, United States
        • Los Angeles Biomedical Institute at Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States
        • University of Colorado
      • Denver, Colorado, United States
        • Apex Research Institute
    • Connecticut
      • New Haven, Connecticut, United States
        • Yale University School of Medicine
      • Norwalk, Connecticut, United States
        • World Health Clinicians' CIRCLE CARE Center
    • District of Columbia
      • Washington, District of Columbia, United States
        • Capital Medical Associates, P.C.
      • Washington, District of Columbia, United States
        • Medical Faculty Associates, Inc.
      • Washington, District of Columbia, United States
        • Whitman Walker Clinic
    • Florida
      • Fort Lauderdale, Florida, United States
        • Gary Richmond, MD, PA, Inc.
      • Fort Lauderdale, Florida, United States
        • Therafirst Medical Centers
      • Fort Pierce, Florida, United States
        • Midway Immunology & Research Center, LLC
      • Miami, Florida, United States
        • University of Miami
      • Miami, Florida, United States
        • AIDS Healthcare Foundation
      • Miami Beach, Florida, United States
        • AIDS Healthcare Foundation
      • Orlando, Florida, United States
        • Orlando Immunology Center
      • Pensacola, Florida, United States
        • Infectious Diseases Associates of NW Florida, P.A.
      • Tampa, Florida, United States
        • Hillsborough County Health Dept.
      • Tampa, Florida, United States
        • Infectious Disease Research Institute Inc.
      • Tampa, Florida, United States
        • St. Joseph's Comprehensive Research Institute
      • Vero Beach, Florida, United States
        • AIDS Research & Treatment Center of the Treasure Coast
      • West Palm Beach, Florida, United States
        • Triple O Research Institute, P.A.
      • Wilton Manors, Florida, United States
        • Rowan Tree Medical PA
    • Georgia
      • Atlanta, Georgia, United States
        • AIDS Research Consortium of Atlanta
      • Atlanta, Georgia, United States
        • Atlanta ID Group
      • Decatur, Georgia, United States
        • Infectious Disease Specialists of Atlanta
      • Macon, Georgia, United States
        • Mercer University School of Medicine
      • Savannah, Georgia, United States
        • Chatham County Health Department
    • Illinois
      • Chicago, Illinois, United States
        • The CORE Foundation
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston University Medical Center
      • Boston, Massachusetts, United States
        • Brigham and Women's
      • Framingham, Massachusetts, United States
        • MetroWest Medical Center
      • Springfield, Massachusetts, United States
        • Baystate Infectious Diseases Clinical Research
      • Springfield, Massachusetts, United States
        • The Research Institute
    • Michigan
      • Berkley, Michigan, United States
        • Be Well Medical Center
      • Detroit, Michigan, United States
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Hennepin County Medical Center
    • Missouri
      • Saint Louis, Missouri, United States
        • Southampton Healthcare, Inc.
    • New Jersey
      • Newark, New Jersey, United States
        • Saint Michael's Medical Center
      • Somers Point, New Jersey, United States
        • South Jersey Infectious Disease
    • New Mexico
      • Santa Fe, New Mexico, United States
        • Southwest CARE Center
    • New York
      • Albany, New York, United States
        • Upstate Infectious Diseases Associates
      • Bronx, New York, United States
        • Montefiore Medical Center
      • Bronx, New York, United States
        • Jacobi Medical Center
      • Manhasset, New York, United States
        • North Shore University Hospital
      • New York, New York, United States
        • Columbia University Medical Center/ New York Presbyterian
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States
        • Infectious Disease Consultants, PA
      • Greenville, North Carolina, United States
        • The Brody School of Medicine
      • Huntersville, North Carolina, United States
        • Rosedale Infectious Diseases
    • Ohio
      • Columbus, Ohio, United States
        • The Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States
        • The Miriam Hospital
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
    • Texas
      • Austin, Texas, United States
        • Central Texas Clinical Research
      • Dallas, Texas, United States
        • North Texas Infectious Diseases Consultants
      • Dallas, Texas, United States
        • Southwest Infectious Disease Clinical Research, Inc.
      • Dallas, Texas, United States
        • Trinity Health and Wellness Center/AIDS Arms, Inc.
      • Fort Worth, Texas, United States
        • AIDS Arms, Inc./Trinity Health & Wellness Center
      • Houston, Texas, United States
        • Gordon E. Crofoot, MD, PA
      • Houston, Texas, United States
        • Research Access Network
      • Longview, Texas, United States
        • DCOL Center for Clinical Research
    • Virginia
      • Annandale, Virginia, United States
        • Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
    • Washington
      • Seattle, Washington, United States
        • Peter Shalit, MD
      • Spokane, Washington, United States
        • Premier Clinical Research

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Currently receiving EFV/FTC/TDF FDC for ≥ 6 consecutive months preceding the screening visit
  • Documented plasma HIV-1 RNA levels < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 6 months preceding the screening visit. Unconfirmed virologic elevation of ≥ 50 copies/mL after previously reaching viral suppression (transient detectable viremia, or "blip") and prior to screening is acceptable
  • Have no documented resistance to any of the study agents at any time in the past
  • HIV-1 RNA < 50 copies/mL at the screening visit
  • Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
  • Serum amylase ≤ 5 × ULN (individuals with serum amylase > 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)
  • Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
  • Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min according to the Cockcroft-Gault formula

Key Exclusion Criteria:

  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody positive with detectable hepatitis C virus (HCV) RNA (individuals who have HCV antibody but no detectable HCV RNA are eligible to enroll)
  • Individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
  • Females who are breastfeeding
  • Positive serum pregnancy test
  • Current alcohol or substance use judged by the Investigator to potentially interfere with the individual's study compliance
  • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline/Day 1 and must not be anticipated to require systemic therapy during the study
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline/Day 1
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
  • Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
  • Individuals receiving ongoing therapy with any of the disallowed medications listed in the protocol, including drugs not to be used with FTC, RPV and/or TAF; or individuals with any known allergies to the excipients of FTC/RPV/TAF

Note: Other protocol defined inclusion/exclusion criteria may apply.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FTC/RPV/TAF
FTC/RPV/TAF plus EFV/FTC/TDF placebo for at least 96 weeks.
Drug: FTC/RPV/TAF
200/25/25 mg FDC tablets administered orally once daily
Other Names:
  • Odefsey®
Drug: EFV/FTC/TDF Placebo
Tablets administered orally once daily
Active Comparator: EFV/FTC/TDF
EFV/FTC/TDF plus FTC/RPV/TAF placebo for at least 96 weeks.
Drug: EFV/FTC/TDF
600/200/300 mg FDC tablets administered orally once daily
Other Names:
  • Atripla®
Drug: FTC/RPV/TAF Placebo
Tablets administered orally once daily
Experimental: Open Label Extension Phase
After the Week 96 visit, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead elects to discontinue the study, whichever occurs first.
Drug: FTC/RPV/TAF
200/25/25 mg FDC tablets administered orally once daily
Other Names:
  • Odefsey®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm
Time Frame: Week 48
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Week 48

Secondary Outcome Measures

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
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Time Frame: Baseline; Week 48
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Baseline; Week 48
Percent Change From Baseline in Hip BMD at Week 96
Time Frame: Baseline; Week 96
Hip BMD was assessed by DXA scan.
Baseline; Week 96
Percent Change From Baseline in Spine BMD at Week 48
Time Frame: Baseline; Week 48
Spine BMD was assessed by DXA scan.
Baseline; Week 48
Percent Change From Baseline in Spine BMD at Week 96
Time Frame: Baseline; Week 96
Spine BMD was assessed by DXA scan.
Baseline; Week 96
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm
Time Frame: Week 48
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Week 48
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm
Time Frame: Week 96
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Week 96
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot
Time Frame: Week 96
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Week 96
Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48
Time Frame: Baseline; Week 48
The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.
Baseline; Week 48
Change From Baseline in HIVSI Score at Week 96
Time Frame: Baseline; Week 96
The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.
Baseline; Week 96

Collaborators and Investigators

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

Sponsor

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 (Actual)

January 26, 2015

Primary Completion (Actual)

June 29, 2016

Study Completion (Actual)

January 2, 2019

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-366-1160
  • 2014-004779-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and transparency

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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