Clinical Trials

MainTitle

Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

This study is ongoing, but not recruiting participants.
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02345252

First received: January 19, 2015
Last updated: November 7, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.

Condition Intervention Phase
HIV-1 Infection

Drug : FTC/RPV/TAF
Drug : FTC/RPV/TDF Placebo
Drug : FTC/RPV/TDF
Drug : FTC/RPV/TAF Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • 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 US FDA-defined 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.
Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • Proportion 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 ]
  • Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline and Week 48 ]
  • Change From Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline and Week 96 ]
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline and Week 48 ]
    Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 96 [ Time Frame: Baseline and Week 96 ]
    Hip BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.
  • Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline and Week 48 ]
    Spine BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
  • Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 96 [ Time Frame: Baseline and Week 96 ]
    Spine BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.

Enrollment: 632
Study Start Date: January 26, 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 22, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: FTC/RPV/TAF
FTC/RPV/TAF FDC plus FTC/RPV/TDF placebo for at least 96 weeks. After the Week 96 visit is completed, participants will be given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks or until Gilead Sciences elects to discontinue the study, whichever occurs first.
Drug: FTC/RPV/TAF

200/25/25 mg FDC tablets administered orally once daily

Other Name: Odefsey®
Drug: FTC/RPV/TDF Placebo

Tablets administered orally once daily

Active Comparator: FTC/RPV/TDF
FTC/RPV/TDF FDC plus FTC/RPV/TAF placebo for at least 96 weeks. After the Week 96 visit is completed, participants will be given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks or until Gilead Sciences elects to discontinue the study, whichever occurs first.
Drug: FTC/RPV/TDF

200/25/300 mg FDC tablets administered orally once daily

Other Name:
  • Complera®
  • Eviplera®

Drug: FTC/RPV/TAF Placebo

Tablets administered orally once daily

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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 FTC/RPV/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. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA ≥ 50 copies/mL followed by resuppression, are allowed
  • 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 (≤ 26 μmol/L), or normal direct bilirubin
  • Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3 (1.00 GI/L); platelets ≥ 50,000/mm^3 (50 GI/L); hemoglobin ≥ 8.5 g/dL (85 g/L))
  • 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 (1.17 mL/sec) 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 subject 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 subject 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 following medications in the
table below, including drugs not to be used with FTC, RPV and/or TAF (refer to the individual agents Prescribing Information); or individuals with any known allergies to the excipients of FTC/RPV/TAF
Note: Other Inclusion/Exclusion criteria may apply.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02345252

Locations

United States, Alabama
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States
United States, California
AHF Research Center
Beverly Hills, California, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Long Beach Education and Research Consultants
Long Beach, California, United States
Kaiser Permanente
Los Angeles, California, United States
Southern California Men's Medical Group
Los Angeles, California, United States
Tarrant County ID Associates
Los Angeles, California, United States
Alameda County Medical Center
Oakland, California, United States
Desert Medical Group Inc., dba Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Kaiser Permanente
Sacramento, California, United States
University of California-UC Davis
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
Optimus Medical
San Francisco, California, United States
Kaiser Permanente
San Leandro, California, United States
Los Angeles BioMedical Institute at Harbor-UCLA Medical Center
Torrance, California, United States
United States, Colorado
University of Colorado
Aurora, Colorado, United States
Apex Research Institute
Denver, Colorado, United States
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States
World Health Clinicians' CIRCLE CARE Center
Norwalk, Connecticut, United States
United States, District of Columbia
Capital Medical Associates, P.C.
Washington, District of Columbia, United States
Dupont Circle Physicians Group
Washington, District of Columbia, United States
Medical Faculty Associates
Washington, District of Columbia, United States
Whitman Walker Clinic
Washington, District of Columbia, United States
United States, Florida
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States
Therafirst Medical Centers
Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
Fort Pierce, Florida, United States
AIDS Healthcare Foundation
Miami Beach, Florida, United States
AIDS Healthcare Foundation
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Infectious Diseases Associates of NW Florida, P.A.
Pensacola, 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
Tampa, Florida, United States
AIDS Research & Treatment Center of the Treasure Coast
Vero Beach, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Rowan Tree Medical PA
Wilton Manors, Florida, United States
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Atlanta ID Group
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States
United States, Massachusetts
Brigham and Women's
Boston, Massachusetts, United States
Community Research Initiative
Boston, Massachusetts, United States
MetroWest Medical Center
Framingham, Massachusetts, United States
Baystate Infectious Diseases Clinical Research
Springfield, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States
United States, Missouri
Southampton Healthcare, Inc.
Saint Louis, Missouri, United States
United States, New Jersey
Jersey Shore Medical Center
Neptune City, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
United States, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States
United States, New York
Upstate Infectious Diseases Associates
Albany, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Montefiore Medical Center
The Bronx, New York, United States
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center--Myers Park Infectious Disease Clinic
Charlotte, North Carolina, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
Trinity Health and Wellness Center/AIDS Arms, Inc.
Dallas, Texas, United States
AIDS Arms, Inc./Trinity Health & Wellness Center
Fort Worth, Texas, United States
Gordon E. Crofoot, MD, PA
Houston, Texas, United States
Research Access Network
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
United States, Virginia
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States
United States, Washington
Peter Shalit, MD
Seattle, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Belgium
CHU Saint-Pierre University Hospital
Brussels, Belgium
Cliniques Universitaires UCL Saint-Luc
Brussels, Belgium
University Hospital Gent
Ghent, Belgium
Canada
University of Alberta
Edmonton, Alberta, Canada
Spectrum Health
Vancouver, British Columbia, Canada
Maple Leaf Research
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Clinique medicale l'Actuel
Montreal, Quebec, Canada
Clinique OPUS
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
France
Hôpital Gui de Chauliac - Service Maladies Infectieuses et Tropicales
Montpellier, France
Germany
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
Berlin, Germany, 10439
University of Bonn
Bonn, Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Infektiologikum
Frankfurt, Germany
Asklepios Klinik
Hamburg, Germany
ICH Study Center Hamburg
Hamburg, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitat zu Koln
Koln, Germany
MUC Research GmbH
München, Germany
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Fondazione IRCCS San Raffaele del Monte Tabor
Milano, Italy
Netherlands
Erasmus MC
Rotterdam, Netherlands
Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, Puerto Rico
Hope Clinical Research
San Juan, Puerto Rico
Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitary de Bellvitge
Barcelona, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Sweden
Karolinska Institutet
Stockholm, Sweden
Switzerland
University Hospital Basel
Basel, Switzerland
Geneva University Hospital
Genève, Switzerland
United Kingdom
NHS Greater Glasgow
Glasgow, United Kingdom
Barts & The London NHS Trust
London, United Kingdom
Chelsea & Westminster Hospital
London, United Kingdom
Mortimer Market Centre
London, United Kingdom
The Royal Free Hampstead NHS Trust
London, United Kingdom
The Hathersage Integrated Contraception, Sexual Health and HIV Service
Manchester, United Kingdom

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02345252   History of Changes  
Other Study ID Numbers: GS-US-366-1216  
  2014-004545-27  
Study First Received: January 19, 2015  
Last Updated: November 7, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Gilead Sciences:

HIV

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Rilpivirine

ClinicalTrials.gov processed this data on December 14, 2017
This information is provided by ClinicalTrials.gov.