Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
NCT ID: NCT01818596
Last Updated: 2020-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
252 participants
INTERVENTIONAL
2013-03-27
2018-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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E/C/F/TAF
Participants will receive E/C/F/TAF for 144 weeks. Following Week 144, in countries where E/C/F/TAF is not available (except for the United Kingdom), participants will be given the option to continue in the study and receive E/C/F/TAF for another 48 weeks, or until the product becomes available through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever comes first.
E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Interventions
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E/C/F/TAF
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must not have a history of known resistance to elvitegravir (EVG), tenofovir disoproxil fumarate (TDF), or emtricitabine (FTC)
* Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels (according to the local assay being used) in the 6 months preceding the screening visit and have HIV-1 RNA \< 50 copies/mL at screening
* Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the Cockcroft-Gault formula for creatinine clearance, using actual weight
* May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that study is complete; or currently receiving Stribild® (STB) or atazanavir (ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that study is complete.
Cohort 2 (treatment-naive)
* Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
* Screening genotype report provided by Gilead Sciences must show sensitivity to EVG, FTC, and TDF
* No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis (PEP), up to 6 months prior to screening
* Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine clearance, using actual weight
All Cohorts:
* The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* CD4+ count of ≥ 50 cells/μL
* Stable renal function: serum creatinine measurements to be taken at least once (within three months of screening)
* Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without change in medical management, for 3 months prior to baseline
* Normal electrocardiogram (ECG)
* Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
* Adequate hematologic function
* Serum amylase ≤ 5 x ULN
* Females of childbearing potential must agree to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence) from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
* 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 throughout the study period and for 30 days following discontinuation of investigational medicinal product. A highly effective method of contraception is defined as two separate forms of contraception, one of which must be an effective barrier method, or males must be non-heterosexually active, or practice sexual abstinence
Exclusion Criteria
* Hepatitis C virus (HCV) antibody positive. Individuals who are HCV positive, but have a documented negative HCV RNA, are eligible
* Hepatitis B surface antigen (HBVsAg) positive
* Individuals receiving drug treatment for Hepatitis C, or individuals who are anticipated to receive treatment for Hepatitis C during the course of the study
* Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
* 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 or ongoing malignancy other than cutaneous Kaposi's sarcoma, 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 baseline
* Individuals on hemodialysis, other forms of renal replacement therapy, or on treatment for underlying kidney diseases (including prednisolone and dexamethasone)
* Individuals receiving ongoing therapy with any medications not to be used with EVG, COBI, FTC, or TAF or individuals with any known allergies to the excipients of E/C/F/TAF
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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Maricopa Integrated Health System - McDowell Clinic
Phoenix, Arizona, United States
Pueblo Family Physicians
Phoenix, Arizona, United States
Health for Life Clinic PLLC
Little Rock, Arkansas, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Kaiser Permanente
Hayward, California, United States
Long Beach Education and Research Consultants
Long Beach, California, United States
LA Gay & Lesbian Center - Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States
Peter J Ruane, MD, Inc
Los Angeles, California, United States
Anthony Mills MD, Inc
Los Angeles, California, United States
Desert Medical Group Inc. dba Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Kaiser Permanente Medical Group
Sacramento, California, United States
Metropolis Medical
San Francisco, California, United States
Kaiser Permanente CTU San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, United States
Gary J. Richmond, MD PA
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Idocf/Valuhealthmd
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Rowan Tree Medical, P.A.
Wilton Manors, Florida, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University
Macon, Georgia, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
Be Well Medical Center, P.C.
Berkley, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
The Kansas City Care Clinic (KC Free Health Clinic)
Kansas City, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
Albany Medical College
Albany, New York, United States
Upstate Infectious Diseases Associates
Albany, New York, United States
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, United States
Aids Care
Rochester, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
University of PA HIV Clinical Trials Unit
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
St. Hope Foundation
Bellaire, Texas, United States
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States
Garcias' Family Health Group
Harlingen, 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
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia
Clinical Research Infectious Diseases Department- Alfred Hospital
Melbourne, Victoria, Australia
Prahran Market Clinic
Prahran, Victoria, Australia
Instituto Dominicano de Estudios Virologicos (IDEV)
Santo Domingo, , Dominican Republic
Hopital de la Croix Rousse
Lyon, , France
GHPS Service des maladies infectieuses et tropicales pavillon Laveran unité de recherche clinique
Paris, , France
Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, Mexico
University Medical Center Utrecht
Utrecht, , Netherlands
Hospital Universitari de Bellvitge
Barcelona, , Spain
Germans Trias i Pujol University Hospital
Barcelona, , Spain
Hospital La Paz
Madrid, , Spain
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, , Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
Bangkok, , Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, , Thailand
Brighton & Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Kings College London
London, , United Kingdom
Chelsea and Westminster NHS Foundation Trust Hospital
London, , United Kingdom
Central Manchester University Hospitals NHS foundation Trust
Manchester, , United Kingdom
Countries
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References
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Pozniak A, Arribas JR, Gathe J, Gupta SK, Post FA, Bloch M, Avihingsanon A, Crofoot G, Benson P, Lichtenstein K, Ramgopal M, Chetchotisakd P, Custodio JM, Abram ME, Wei X, Cheng A, McCallister S, SenGupta D, Fordyce MW; GS-US-292-0112 Study Team. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):530-7. doi: 10.1097/QAI.0000000000000908.
Post FA, Tebas P, Clarke A, Cotte L, Short WR, Abram ME, Jiang S, Cheng A, Das M, Fordyce MW. Brief Report: Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Adults With Renal Impairment: 96-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):180-184. doi: 10.1097/QAI.0000000000001186.
Other Identifiers
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2013-000516-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-292-0112
Identifier Type: -
Identifier Source: org_study_id
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