Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
2 other identifiers
interventional
252
9 countries
70
Brief Summary
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv
Started Mar 2013
Longer than P75 for phase_3 hiv
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2013
CompletedFirst Posted
Study publicly available on registry
March 26, 2013
CompletedStudy Start
First participant enrolled
March 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2014
CompletedResults Posted
Study results publicly available
February 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2018
CompletedMarch 2, 2020
June 1, 2019
1.3 years
March 22, 2013
December 4, 2015
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24
eGFR is a measurement of the kidney's ability to filter blood.
Baseline; Week 24
Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24
eGFR is a measurement of the kidney's ability to filter blood. The eGFR\_CKD-EPI,cysC method is adjusted for age and sex.
Baseline; Week 24
Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24
eGFR is a measurement of the kidney's ability to filter blood. The eGFR\_CKD-EPI,creatinine method is adjusted for age, race, and sex.
Baseline; Week 24
Secondary Outcomes (18)
Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy
Baseline; Week 2, 4, or 8; Week 24
Percent Change From Baseline in C-type Collagen Sequence (CTX) at Weeks 24 and 48
Baseline; Weeks 24 and 48
Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 24 and 48
Baseline; Weeks 24 and 48
Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144
Baseline; Weeks 24, 48, 96, and 144
Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144
Baseline; Weeks 24, 48, 96, and 144
- +13 more secondary outcomes
Study Arms (1)
E/C/F/TAF
EXPERIMENTALParticipants 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.
Interventions
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
Eligibility Criteria
You may qualify if:
- Cohort 1 (treatment-experienced switch)
- 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
- +8 more criteria
You may not qualify if:
- A new AIDS-defining condition (excluding CD4 cell count and percentage criteria) diagnosed within the 30 days prior to screening,with the exception of the first two bullet points
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (70)
Maricopa Integrated Health System - McDowell Clinic
Phoenix, Arizona, 85006, United States
Pueblo Family Physicians
Phoenix, Arizona, 85015, United States
Health for Life Clinic PLLC
Little Rock, Arkansas, 72207, United States
Pacific Oaks Medical Group
Beverly Hills, California, 90211, United States
Kaiser Permanente
Hayward, California, 94545, United States
Long Beach Education and Research Consultants
Long Beach, California, 90813, United States
LA Gay & Lesbian Center - Jeffrey Goodman Special Care Clinic
Los Angeles, California, 90028, United States
Peter J Ruane, MD, Inc
Los Angeles, California, 90036, United States
Anthony Mills MD, Inc
Los Angeles, California, 90069, United States
Desert Medical Group Inc. dba Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Kaiser Permanente Medical Group
Sacramento, California, 95825, United States
Metropolis Medical
San Francisco, California, 94109, United States
Kaiser Permanente CTU San Francisco
San Francisco, California, 94118, United States
University of Colorado
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009, United States
Gary J. Richmond, MD PA
Fort Lauderdale, Florida, 33316, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982, United States
Idocf/Valuhealthmd
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33602, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33401, United States
Rowan Tree Medical, P.A.
Wilton Manors, Florida, 33305, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033, United States
Mercer University
Macon, Georgia, 31210, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Community Research Initiative of New England
Boston, Massachusetts, 02111, United States
The Research Institute
Springfield, Massachusetts, 01105, United States
Be Well Medical Center, P.C.
Berkley, Michigan, 48210, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
The Kansas City Care Clinic (KC Free Health Clinic)
Kansas City, Missouri, 64111, United States
Southampton Healthcare, Inc.
St Louis, Missouri, 63139, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
Southwest CARE Center
Santa Fe, New Mexico, 87505, United States
Albany Medical College
Albany, New York, 12208, United States
Upstate Infectious Diseases Associates
Albany, New York, 12208, United States
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, 11030, United States
Aids Care
Rochester, New York, 14607, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0405, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
University of PA HIV Clinical Trials Unit
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
St. Hope Foundation
Bellaire, Texas, 77401, United States
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, 75246, United States
Garcias' Family Health Group
Harlingen, Texas, 78550, United States
Therapeutic Concepts, PA
Houston, Texas, 77004, United States
Gordon E. Crofoot MD, PA
Houston, Texas, 77098, United States
Peter Shalit, MD
Seattle, Washington, 98104, United States
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010, Australia
Clinical Research Infectious Diseases Department- Alfred Hospital
Melbourne, Victoria, 3004, Australia
Prahran Market Clinic
Prahran, Victoria, 3181, Australia
Instituto Dominicano de Estudios Virologicos (IDEV)
Santo Domingo, 99999, Dominican Republic
Hopital de la Croix Rousse
Lyon, 69004, France
GHPS Service des maladies infectieuses et tropicales pavillon Laveran unité de recherche clinique
Paris, 75651, France
Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, 44340, Mexico
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Hospital Universitari de Bellvitge
Barcelona, 8907, Spain
Germans Trias i Pujol University Hospital
Barcelona, 8916, Spain
Hospital La Paz
Madrid, 28046, Spain
HIV-NAT, Thai Red Cross AIDS Research Centre
Bangkok, 10330, Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital
Bangkok, 10700, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002, Thailand
Brighton & Sussex University Hospitals NHS Trust
Brighton, BN2 1ES, United Kingdom
Kings College London
London, SE5 9RJ, United Kingdom
Chelsea and Westminster NHS Foundation Trust Hospital
London, Sw10 9NH, United Kingdom
Central Manchester University Hospitals NHS foundation Trust
Manchester, M13 0FH, United Kingdom
Related Publications (2)
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.
PMID: 26627107RESULTPost 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.
PMID: 27673443RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Enrollment in Cohort 2 (treatment-naive) was low, which affects the interpretation of the data.
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2013
First Posted
March 26, 2013
Study Start
March 27, 2013
Primary Completion
July 31, 2014
Study Completion
July 18, 2018
Last Updated
March 2, 2020
Results First Posted
February 18, 2016
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.