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Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02121795
First received: April 22, 2014
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

This study will evaluate the efficacy and safety of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC versus maintaining a treatment regimen of FTC/TDF FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. Efficacy will be determined by the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48.

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.


Condition Intervention Phase
HIV-1 Infection
Drug: FTC/TDF
Drug: F/TAF
Drug: Allowed third antiretroviral agent
Drug: Placebo to match FTC/TDF
Drug: Placebo to match F/TAF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot analysis [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in hip bone mineral density (BMD) [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
  • Percent change from baseline in spine BMD [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]
  • Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the FDA snapshot analysis [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Proportion of participants with HIV-1 RNA < 20 copies/mL as defined by the FDA snapshot analysis [ Time Frame: Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4+ cell count [ Time Frame: Baseline to Weeks 48 and 96 ] [ Designated as safety issue: No ]
  • Percent change from baseline in hip and spine BMD [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 660
Study Start Date: May 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: F/TAF
Participants will receive emtricitabine 200 mg/tenofovir alafenamide 10 mg or 25 mg (F/TAF) plus placebo to match FTC/TDF, 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.
Drug: F/TAF
F/TAF FDC tablet administered orally once daily
Drug: 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, ritonavir-boosted lopinavir, ritonavir-boosted darunavir, efavirenz (as individual agent only), rilpivirine (as individual agent only), nevirapine, raltegravir, dolutegravir, and maraviroc.
Drug: Placebo to match FTC/TDF
Placebo to match FTC/TDF FDC tablets administered orally once daily
Active Comparator: FTC/TDF
Participants will receive emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) plus placebo to match F/TAF, while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks.
Drug: FTC/TDF
FTC/TDF FDC tablets administered orally once daily
Other Name: Truvada®
Drug: 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, ritonavir-boosted lopinavir, ritonavir-boosted darunavir, efavirenz (as individual agent only), rilpivirine (as individual agent only), nevirapine, raltegravir, dolutegravir, and maraviroc.
Drug: Placebo to match F/TAF
Placebo to match F/TAF FDC tablets administered orally once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • 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:

  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • 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.
  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: NCT02121795

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, California
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
Kaiser Permanente
Hayward, California, United States, 94545
Anthony Mills MD, Inc
Los Angeles, California, United States, 90069
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Highland Hospital - Alameda Health System (formerly Alameda County medical Center)
Oakland, California, United States, 94602
Kaiser permanente medical group
Sacramento, California, United States, 95825
La Playa Medical Group and Clinical Research
San Diego, California, United States, 92103
Kaiser Permanente Medical Group San Francisco
San Francisco, California, United States, 94118
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
Apex Research LLC
Denver, Colorado, United States, 80209
Kaiser Permanente Colorado
Denver, Colorado, United States, 80205
National Jewish Health
Denver, Colorado, United States, 80206
United States, District of Columbia
Capital Medical Associates
Washington, District of Columbia, United States, 20036
Dupont Circle Physician's Group
Washington, District of Columbia, United States, 20009
Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Whitman-Walker Health
Washington, District of Columbia, United States, 20009
United States, Florida
Gary J. Richmond,M.D.,P.A.
Fort Lauderdale, Florida, United States, 33316
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
TheraFirst Medical Center
Ft. Lauderdale, Florida, United States, 33308
AHF - Kinder Medical Group
Miami, Florida, United States, 33133
AIDS Healthcare Foundation
Miami Beach, Florida, United States, 33139
Orlando Immunology Center
Orlando, Florida, United States, 32803
Infectious Diseases Associates of NW FL
Pensacola, Florida, United States, 32504
St. Joseph's Comprehensive Research Institute
Tampa, Florida, United States, 33614
University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department
Tampa, Florida, United States, 33602
AIDS Research & Treatment Center of the Treasure Coast
Vero Beach, Florida, United States, 32960
Triple O Research Institute PA
West Palm Beach, Florida, United States, 33401
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30312
Atlanta ID Group
Atlanta, Georgia, United States, 30309
Mercer University School of Medicine
Macon, Georgia, United States, 31201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Community Research Initiative of New England
Boston, Massachusetts, United States, 02111
United States, Michigan
Be Well Medical Center
Berkley, Michigan, United States, 48072
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
The Kc Care Clinic Site 5580
Kansas City, Missouri, United States, 64111
Southampton Healthcare, Inc.
St Louis, Missouri, United States, 63139
St. Louis University
St. Louis, Missouri, United States, 63110
United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
South Jersey Infectious Disease
Somers Point, New Jersey, United States, 08244
United States, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Hospital Queens
Flushing, New York, United States, 11355
North Shore University Hospital
Manhasset, New York, United States, 11030
Ricky K. Hsu, MD, PC
New York, New York, United States, 10011
Jacobi Medical Center
South Bronx, New York, United States, 10461
United States, North Carolina
Infectious Disease Consultants, PA
Charlotte, North Carolina, United States, 28209
Rosedale Infectious Diseases
Huntersville, North Carolina, United States, 28078
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
AIDS Arms, Inc
Dallas, Texas, United States, 75215
North Texas Infectious Diseases Consulants
Dallas, Texas, United States, 75246
Southwest Infectious Disease Clinical Research, Inc
Dallas, Texas, United States, 75219
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Gordon E. Crofoot MD PA
Houston, Texas, United States, 77098
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Washington
Peter Shalit, MD
Seattle, Washington, United States, 98104
Rockwood Pulomonary & Critical Care
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Belgium
CHU Saint-Pierre of Brussels
Brussels, Belgium, 1000
University Hospital Erasme
Brussels, Belgium, 1070
Canada, British Columbia
Vancouver Infectious Disease Research and Care Centre
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Ontario
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada, K1Y 4E9
Maple Leaf Medical Clinic/Maple Leaf Research
Toronto, Ontario, Canada, M5B 1L6
University Health Network/Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
France
University Hospital of Montpellier (CHU-Gui de Chauliac)
Montpelier Cedex 5, France, 34295
CHU de Nantes Hopital de l'Hotel Dieu
Nantes, France, 44093
Hopital Bichat Claude Bernard
Paris, France, 75018
Hôpital Tenon
Paris, France, 75020
Centre Hospitalier de Tourcoing
Tourcoing, France, 59208
Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy, 24127
IRCCS Ospedale San Raffaele, Centro San Luigi
Milano, Italy, 20127
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.
Rome, Italy, 00149
UOC Malattie Infettive Universitarie, Azienda Ospedaliera Universitaria Senese
Siena, Italy, 53100
Puerto Rico
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909-1711
HOPE Clinical Research
San Juan, Puerto Rico, 00901
University of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00935
United Kingdom
Brighton and Sussex University Hospitals
Brighton, United Kingdom, BN2 1ES
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9TH
King's College Hospital
London, United Kingdom, SE5 9RJ
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Barts Health NHS Trust
London, United Kingdom, E1 1BB
Manchester Centre for Sexual Health
Manchester, United Kingdom, M13 0FH
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Martin Rhee, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02121795     History of Changes
Other Study ID Numbers: GS-US-311-1089, 2013-005138-39
Study First Received: April 22, 2014
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
European Union: European Medicines Agency
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Gilead Sciences:
HIV
HIV-1 Positive
Virologically-suppressed

Additional relevant MeSH terms:
Anti-Retroviral Agents
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014