Phase
Condition
Hiv Infections
Aids And Aids Related Infections
Hiv/aids
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability to understand and sign a written informed consent form
Be on a stable antiretroviral regimen consisting of a ritonavir boosted PI plusFTC/TDF continuously for ≥ 6 consecutive months preceding the screening visit
Be on the first or second antiretroviral drug regimen documented undetectable plasmaHIV 1 RNA levels for ≥ 6 months preceding the screening visit
No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) for any length of time
Documented historical genotype prior to starting initial antiretroviral therapyshowing no known resistance to TDF or FTC
HIV RNA < 50 copies/mL at screening
Normal ECG
Hepatic transaminases ≤ 5 × the upper limit of the normal range (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 × ULN
Estimated glomerular filtration rate ≥ 70 mL/min
Females of childbearing potential must agree to utilize highly effective contraceptionmethods, or be nonheterosexually active, practice sexual abstinence from screeningthroughout the duration of the study period and for 30 days following the last dose ofstudy drug
Female participants who utilize hormonal contraceptive as one of their birth controlmethods must have used the same method for at least three months prior to study dosing
Male participants must agree to utilize a highly effective method of contraceptionduring heterosexual intercourse from the screening visit, throughout the duration ofthe study and for 30 days following discontinuation of investigational medicinalproduct, or must be nonheterosexually active, or practice sexual abstinence
Age ≥ 18 years
Exclusion
Exclusion Criteria:
A new AIDS-defining condition diagnosed within the 30 days prior to screening
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Receiving drug treatment for hepatitis C, or participants who are anticipated toreceive treatment for hepatitis C during the course of the study
Experiencing decompensated cirrhosis
Have an implanted defibrillator or pacemaker
Current alcohol or substance abuse that would interfere with compliance
A history of malignancy within the past 5 years or ongoing malignancy other thancutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneoussquamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapywithin 30 days prior to Baseline, except for intramuscular penicillin for thetreatment of syphilis
Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3months of study screening, or expected to receive these agents or systemic steroidsduring the study
Receiving ongoing therapy with any of the medications, including drugs not to be usedwith elvitegravir, cobicistat, FTC, or TDF; or those with any known allergies to theexcipients of E/C/F/TDF tablets, or FTC/TDF tablets
No anticipated need to initiate drugs during the study that are contraindicated
Receiving other investigational drugs
Participation in any other clinical trial
Any other clinical condition or prior therapy that would make the participantunsuitable for the study or unable to comply with the dosing requirements
Study Design
Connect with a study center
Innsbruck Medical University
Innsbruck, A 6020
AustriaSite Not Available
Univ.-Kklinik fuer Innere Medizin III
Salzburg, 5020
AustriaSite Not Available
Medical University of Vienna
Vienna, 1090
AustriaSite Not Available
Otto-Wagner-Spital
Wien, 1140
AustriaSite Not Available
UCL Saint Luc
Brussels, 01200
BelgiumSite Not Available
University Hospital Ghent
Ghent, 9000
BelgiumSite Not Available
CHU Sart Tilman
Liege, 4000
BelgiumSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Clinique Medicale Du Quartier Latin
Montreal, Quebec H2L 5B1
CanadaSite Not Available
CHU de Besancon, Hopital Saint-Jacques
Besançon, 25030
FranceSite Not Available
Hôpital de la Croix-Rousse
Lyon, 69317
FranceSite Not Available
CHU Hôpital Gui de Chauliac
Montpellier, 34295
FranceSite Not Available
Archet 1 Chu Nice Department of Infectology
Nice, 06202
FranceSite Not Available
Hopital Saint Antoine
Paris, 75012
FranceSite Not Available
Hôpital Bichat-Claude Bernard
Paris, 75018
FranceSite Not Available
Saint-Louis Hospital
Paris, 75010
FranceSite Not Available
hôpital Tenon
Paris, 75020
FranceSite Not Available
Maladies Infectieuses Dpt
Paris Cedex 13, 75651
FranceSite Not Available
Hôpital Haut Lévêque
Pessac, 33604
FranceSite Not Available
Epimed GmbH
Berlin, 12157
GermanySite Not Available
University of Bonn
Bonn, 53127
GermanySite Not Available
Universitätsklinikum Essen, Dermatologie, HIV Ambulanz
Essen, 45147
GermanySite Not Available
Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68
Frankfurt, 60590
GermanySite Not Available
ICH Study Center
Hamburg, 20146
GermanySite Not Available
Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie
Hamburg, 20246
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Infektlonsambulanz Unlkllnik Koln
Koln, 50937
GermanySite Not Available
Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen
Munich, 80336
GermanySite Not Available
Ospedali Riuniti
Bergamo, 24128
ItalySite Not Available
Clinic of Infectious Diseases, University of Milan-San Paolo Hospital
Milan, 20142
ItalySite Not Available
Clinic of Infectious Diseases, University of Milan-San Paolo Hospital
Milano, 20142
ItalySite Not Available
Fondazione Centro San Raffaele
Milano, 20127
ItalySite Not Available
Ospedale Luigi Sacco
Milano, 20157
ItalySite Not Available
National Institute for Infectious Diseases "L. Spallanzani"
Rome, 00149
ItalySite Not Available
University of Torino, Dept of Infectious Disease
Torino, 10122
ItalySite Not Available
HHP Hospital de Cascais
Alcabideche, 2755
PortugalSite Not Available
Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa
Lisboa, 1150-069
PortugalSite Not Available
Hospital de Santa Maria-CHLN, EPE
Lisbon, 1049-035
PortugalSite Not Available
Clinical Research Puert Rico
San Juan, 00909
Puerto RicoSite Not Available
University of Puerto Rico School of Medicine
San Juan, 00935
Puerto RicoSite Not Available
Hospital General Universitario Alicante
Alicante, 03010
SpainSite Not Available
Hospital Germans Trias I Pujol
Barcelona, 08916
SpainSite Not Available
Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.
Barcelona, 08907
SpainSite Not Available
Hospital clinic
Barcelona, 08036
SpainSite Not Available
Hospital General Universitario de Elche
Elche, Alicante, 03202
SpainSite Not Available
Hospital La Paz
Madrid, 28760
SpainSite Not Available
Hospital Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Infectious Diseases Department, Hospital Carlos III
Madrid, 28029
SpainSite Not Available
Hospital Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Geneva University Hospital
Geneva, 1205
SwitzerlandSite Not Available
University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology
Zurich, 8091
SwitzerlandSite Not Available
Zentrum fur Infektionskrankheiten
Zurich, CH-8038
SwitzerlandSite Not Available
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN21ES
United KingdomSite Not Available
Chelsea and Westminster
London, SW109NH
United KingdomSite Not Available
Royal Free Hampstead NHS Trust
London, NW32QG
United KingdomSite Not Available
Pueblo Family Physicians
Phoenix, Arizona 85015
United StatesSite Not Available
Spectrum Medical Group
Phoenix, Arizona 85012
United StatesSite Not Available
Health for Life Clinic PLLC
Little Rock, Arkansas 72207
United StatesSite Not Available
AIDS Healthcare Foundation
Beverly Hills, California 90211
United StatesSite Not Available
Pacific Oaks Medical Group
Beverly Hills, California 90211
United StatesSite Not Available
Kaiser Permanente
Hayward, California 94545
United StatesSite Not Available
Anthony Mills MD Inc
Los Angeles, California 90069
United StatesSite Not Available
Kaiser Permanente
Los Angeles, California 90027
United StatesSite Not Available
OASIS Clinic
Los Angeles, California 90043
United StatesSite Not Available
Peter J. Ruane, M.D., Inc.
Los Angeles, California 90036
United StatesSite Not Available
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Kaiser Permanente
Sacramento, California 95841
United StatesSite Not Available
University of California, Davis
Sacramento, California 95817
United StatesSite Not Available
La Playa Medical Group and Clinical Research
San Diego, California 92103
United StatesSite Not Available
Kaiser Permanente San Francisco
San Francisco, California 94118
United StatesSite Not Available
Metropolis Medical
San Francisco, California 94109
United StatesSite Not Available
Capital Medical Associates, PC
Washington, District of Columbia 20036
United StatesSite Not Available
Dupont Circle Physicians Group, P.C
Washington, District of Columbia 20009
United StatesSite Not Available
Gary Richmond, MD
Fort Lauderdale, Florida 33316
United StatesSite Not Available
Midway Immunology & Research Center, LLC
Fort Pierce, Florida 34982
United StatesSite Not Available
The Kinder Medical Group
Miami, Florida 33133
United StatesSite Not Available
Idocf/Valuhealthmd, Llc
Orlando, Florida 32806
United StatesSite Not Available
Orlando Immunology Center
Orlando, Florida 32803
United StatesSite Not Available
Infectious Diseases Associates of NW FL, P.A.
Pensacola, Florida 32504
United StatesSite Not Available
AHF Health Positive Tampa Bay
Safety Harbor, Florida 34695
United StatesSite Not Available
St. Joseph's Comprehensive Research Institute
Tampa, Florida 33614
United StatesSite Not Available
Atlanta ID Group
Atlanta, Georgia 30309
United StatesSite Not Available
John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center
Chicago, Illinois 60612
United StatesSite Not Available
Northwestern University Division of Infectious Diseases
Chicago, Illinois 60611
United StatesSite Not Available
Be Well Medical Center
Berkley, Michigan 48072
United StatesSite Not Available
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United StatesSite Not Available
The Kansas City Free Health Clinic
Kansas City, Missouri 64111
United StatesSite Not Available
I.D. Care Associates PA
Hillsborough, New Jersey 08844
United StatesSite Not Available
Saint Michael's Medical Center
Newark, New Jersey 07102
United StatesSite Not Available
South Jersey Infectious Disease
Somers Point, New Jersey 08244
United StatesSite Not Available
Greiger Clinic
Mt. Vernon, New York 10550
United StatesSite Not Available
ID Consultants, P.A.
Charlotte, North Carolina 28209
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Philadelphia FIGHT
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Southwest Infectious Disease Clinical Research, Inc
Dallas, Texas 75219
United StatesSite Not Available
Uptown Physicians Group
Dallas, Texas 75204
United StatesSite Not Available
Tarrant County Infectious Disease Associates
Fort Worth, Texas 76104
United StatesSite Not Available
Gordon Crofoot Md, Pa
Houston, Texas 77098
United StatesSite Not Available
St. Hope Foundation Inc
Houston, Texas 77401
United StatesSite Not Available
Therapeutic Concepts, PA
Houston, Texas 77004
United StatesSite Not Available
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