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)
- Conditions
- HIV-1 Infection
- Interventions
- Registration Number
- NCT02345252
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 632
- 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
- 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 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 Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FTC/RPV/TAF FTC/RPV/TDF Placebo FTC/RPV/TAF plus FTC/RPV/TDF placebo for at least 96 weeks. FTC/RPV/TDF FTC/RPV/TDF FTC/RPV/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. Open Label Extension Phase FTC/RPV/TAF After the Week 96 visit is completed, 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 Sciences elects to discontinue the study, whichever occurs first. FTC/RPV/TDF FTC/RPV/TAF Placebo FTC/RPV/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. FTC/RPV/TAF FTC/RPV/TAF FTC/RPV/TAF plus FTC/RPV/TDF placebo for at least 96 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm 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
Name Time Method Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm 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.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm 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.
Change From Baseline in CD4+ Cell Count at Week 96 Baseline; Week 96 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm 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.
Change From Baseline in CD4+ Cell Count at Week 48 Baseline; Week 48 Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 Baseline; Week 48 Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.
Percent Change From Baseline in Hip BMD at Week 96 Baseline; Week 96 Hip BMD was assessed by DXA scan.
Percent Change From Baseline in Spine BMD at Week 96 Baseline; Week 96 Spine BMD was assessed by DXA scan.
Percent Change From Baseline in Spine BMD at Week 48 Baseline; Week 48 Spine BMD was assessed by DXA scan.
Trial Locations
- Locations (113)
University Health Network
🇨🇦Toronto, Ontario, Canada
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
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
Los Angeles BioMedical Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
World Health Clinicians' CIRCLE CARE Center
🇺🇸Norwalk, Connecticut, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Capital Medical Associates, P.C.
🇺🇸Washington, District of Columbia, United States
Whitman Walker Clinic
🇺🇸Washington, District of Columbia, United States
Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
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
Infectious Diseases Associates of NW Florida, P.A.
🇺🇸Pensacola, 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
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
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
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
Southampton Healthcare, Inc.
🇺🇸Saint Louis, Missouri, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Southwest CARE Center
🇺🇸Santa Fe, New Mexico, United States
Upstate Infectious Diseases Associates
🇺🇸Albany, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Carolinas Medical Center--Myers Park Infectious Disease Clinic
🇺🇸Charlotte, North Carolina, United States
Rosedale Infectious Diseases
🇺🇸Huntersville, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, 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
Research Access Network
🇺🇸Houston, Texas, United States
Gordon E. Crofoot, MD, PA
🇺🇸Houston, Texas, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
🇺🇸Annandale, Virginia, United States
Peter Shalit, MD
🇺🇸Seattle, Washington, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
CHU Saint-Pierre University Hospital
🇧🇪Brussels, Belgium
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Maple Leaf Research
🇨🇦Toronto, Ontario, Canada
Spectrum Health
🇨🇦Vancouver, British Columbia, Canada
Clinique medicale l'Actuel
🇨🇦Montreal, Quebec, Canada
University of Bonn
🇩🇪Bonn, Germany
Hôpital Gui de Chauliac - Service Maladies Infectieuses et Tropicales
🇫🇷Montpellier, France
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
🇩🇪Berlin, Germany
Center for HIV and Hepatogastroenterology
🇩🇪Düsseldorf, Germany
Asklepios Klinik
🇩🇪Hamburg, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
ICH Study Center Hamburg
🇩🇪Hamburg, Germany
Infektiologikum
🇩🇪Frankfurt, Germany
Universitat zu Koln
🇩🇪Koln, Germany
Universitatsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
MUC Research GmbH
🇩🇪München, Germany
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, 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
Karolinska Institutet
🇸🇪Stockholm, Sweden
University Hospital Basel
🇨🇭Basel, Switzerland
NHS Greater Glasgow
🇬🇧Glasgow, United Kingdom
Barts & The London NHS Trust
🇬🇧London, United Kingdom
Chelsea & Westminster Hospital
🇬🇧London, United Kingdom
The Royal Free Hampstead NHS Trust
🇬🇧London, United Kingdom
Mortimer Market Centre
🇬🇧London, United Kingdom
The Hathersage Integrated Contraception, Sexual Health and HIV Service
🇬🇧Manchester, United Kingdom
La Playa Medical Group and Clinical Research
🇺🇸San Diego, California, United States
Kaiser Permanente
🇺🇸San Leandro, California, United States
Optimus Medical
🇺🇸San Francisco, California, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Fondazione IRCCS San Raffaele del Monte Tabor
🇮🇹Milano, Italy
The University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Apex Research Institute
🇺🇸Denver, Colorado, United States
Hillsborough County Health Dept.
🇺🇸Tampa, Florida, United States
St. Joseph's Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Infectious Disease Research Institute Inc.
🇺🇸Tampa, Florida, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States
University Hospital Gent
🇧🇪Ghent, Belgium
Cliniques Universitaires UCL Saint-Luc
🇧🇪Brussels, Belgium
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Jersey Shore Medical Center
🇺🇸Neptune, New Jersey, United States
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Hope Clinical Research
🇵🇷San Juan, Puerto Rico
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Clinique OPUS
🇨🇦Montreal, Quebec, Canada
Geneva University Hospital
🇨🇭Genève, Switzerland
Erasmus MC
🇳🇱Rotterdam, Netherlands
University of California-UC Davis
🇺🇸Sacramento, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
AIDS Healthcare Foundation
🇺🇸Miami, Florida, United States