Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF
NCT ID: NCT02121795
Last Updated: 2020-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
668 participants
INTERVENTIONAL
2014-05-06
2019-03-01
Brief Summary
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This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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F/TAF + 3rd Agent
Participants will receive F/TAF (200/25 mg or 200/10 mg) plus FTC/TDF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. Dosing of F/TAF will be dependent on the third agent of the participants' pre-existing treatment regimen.
F/TAF
Tablets administered orally once daily
Allowed third antiretroviral agent
An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).
FTC/TDF Placebo
Tablets administered orally once daily
FTC/TDF + 3rd Agent
Participants will receive FTC/TDF plus F/TAF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks.
FTC/TDF
200/300 mg FDC tablets administered orally once daily
Allowed third antiretroviral agent
An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).
F/TAF Placebo
Tablets administered orally once daily
Interventions
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FTC/TDF
200/300 mg FDC tablets administered orally once daily
F/TAF
Tablets administered orally once daily
Allowed third antiretroviral agent
An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).
FTC/TDF Placebo
Tablets administered orally once daily
F/TAF Placebo
Tablets administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently receiving antiretroviral regimen containing FTC/TDF in combination with one third agent for ≥ 6 consecutive months prior to screening.
* Plasma HIV-1 RNA levels \< 50 copies/mL for at least 6 months preceding the screening visit (measured at least twice using the same assay) and not experienced two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year.
* Plasma HIV-1 RNA should be \< 50 copies/mL at the screening visit.
* Normal electrocardiogram (ECG)
* Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper limit of the normal range (ULN)
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (individuals with documented Gilbert's syndrome or with Atazanavir-associated hyperbilirubinemia may have total bilirubin up to 5 x ULN)
* Adequate hematologic function
* Serum amylase ≤ 5 × ULN
* Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active, or practice abstinence from screening throughout the duration of the study treatment and for 30 days following the last dose of the study drug.
* Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range.
* Females 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.
* Males must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
Exclusion Criteria
* Hepatitis C virus (HCV) antibody positive and HCV RNA detectable
* Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
* Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis)
* Females who are breastfeeding
* Positive serum pregnancy test
* Have an implanted defibrillator or pacemaker
* Current alcohol or substance use judged by the investigator to potentially interfere with 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.
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 Visit
* Individuals receiving ongoing therapy with any of the medications not to be used with FTC, TAF, TDF or other antiretroviral third agents.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Kaiser Permanente
Hayward, California, United States
Tarrant County ID Associates
Los Angeles, California, United States
Southern California Men's Medical Group
Los Angeles, California, United States
Highland Hospital - Alameda Health System (formerly Alameda County medical Center)
Oakland, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Kaiser Permanente Medical Group San Francisco
San Francisco, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Kaiser Permanente Colorado
Denver, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Apex Research LLC
Denver, Colorado, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, United States
Whitman-Walker Health
Washington D.C., District of Columbia, United States
Capital Medical Associates
Washington D.C., District of Columbia, United States
Medical Faculty Associates
Washington D.C., District of Columbia, United States
TheraFirst Medical Center
Fort Lauderdale, Florida, United States
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Tarrant County Infectious Disease Associates
Miami, Florida, United States
AIDS Healthcare Foundation
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
AIDS Healthcare Foundation
Tampa, Florida, United States
AIDS Research & Treatment Center of the Treasure Coast
Vero Beach, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
Atlanta ID Group
Atlanta, Georgia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Be Well Medical Center
Berkley, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
The Kc Care Clinic Site 5580
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
Prime Healthcare Services - St Michael's LLC d/b/a Saint Michael's Medical Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
New York Hospital Queens
Flushing, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Ricky K. Hsu, MD, PC
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Infectious Disease Consultants, PA
Charlotte, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Central Texas Clinical Research
Austin, Texas, United States
AIDS Arms, Inc
Dallas, Texas, United States
Southwest Infectious Disease Clinical Research, Inc
Dallas, Texas, United States
North Texas Infectious Diseases Consulants
Dallas, Texas, United States
AIDS Arms, Inc./Trinity Health & Wellness Center
Fort Worth, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Gordon E. Crofoot MD PA
Houston, Texas, United States
Peter Shalit, MD
Seattle, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
CHU Saint-Pierre of Brussels
Brussels, , Belgium
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia, Canada
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
Maple Leaf Medical Clinic/Maple Leaf Research
Toronto, Ontario, Canada
University Health Network/Toronto General Hospital
Toronto, Ontario, Canada
University Hospital of Montpellier (CHU-Gui de Chauliac)
Montpellier, , France
CHU de Nantes Hopital de l'Hotel Dieu
Nantes, , France
Hopital Bichat Claude Bernard
Paris, , France
Hôpital Tenon
Paris, , France
Centre Hospitalier de Tourcoing
Tourcoing, , France
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
IRCCS Ospedale San Raffaele, Centro San Luigi
Milan, , Italy
Hope Clinical Research
San Juan, , Puerto Rico
Clinical Research Puerto Rico Inc
San Juan, , Puerto Rico
University of Puerto Rico School of Medicine
San Juan, , Puerto Rico
Brighton and Sussex University Hospitals
Brighton, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Manchester Centre for Sexual Health
Manchester, , United Kingdom
Countries
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References
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Gallant JE, Daar ES, Raffi F, Brinson C, Ruane P, DeJesus E, Johnson M, Clumeck N, Osiyemi O, Ward D, Morales-Ramirez J, Yan M, Abram ME, Plummer A, Cheng AK, Rhee MS. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016 Apr;3(4):e158-65. doi: 10.1016/S2352-3018(16)00024-2. Epub 2016 Mar 14.
Other Identifiers
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2013-005138-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-311-1089
Identifier Type: -
Identifier Source: org_study_id
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