Phase
Condition
Hiv/aids
Hiv Infections
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
Plasma HIV-1 RNA levels ≥ 2,500 copies/mL at screening
No prior use of any approved or experimental anti-HIV drug for any length of time
Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPVmutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y
Normal ECG
Hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) ≤ 5 x the upper limit of the normal range (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 x ULN (participants with serum amylase > 5 x ULN remained eligibleif serum lipase was ≤ 5 x ULN)
Adequate renal function
Males and Females of childbearing potential must have agreed to utilize highlyeffective contraception methods (two separate forms of contraception, one of whichmust be an effective barrier method, or be non-heterosexually active, practice sexualabstinence or have a vasectomized partner) from screening throughout the duration ofstudy period and for 12 weeks following the last dose of study drug.
Adult (≥ 18 years) males or non-pregnant females
Exclusion
Exclusion Criteria:
A new AIDS-defining condition diagnosed within the 30 days prior to screening
Females who were breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Proven or suspected acute hepatitis in the 30 days prior to study entry
Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated toreceive treatment for hepatitis C during the course of the study
Subjects experiencing decompensated cirrhosis
Had an implanted defibrillator or pacemaker
Current alcohol or substance abuse
A history of malignancy within the past 5 years or ongoing malignancy other thancutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneoussquamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapywithin 30 days prior to baseline
Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/naturalsupplements during the study that are contraindicated or not recommended for use,including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with knownallergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens
Participation in any other clinical trial without prior approval from the sponsor wasprohibited while participating in this trial.
Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3months of study screening, or expected to receive these agents or systemic steroidsfor immunosuppression during the study (eg, corticosteroids, immunoglobulins, andother immune-based or cytokine-based therapies)
Had any other clinical condition or prior therapy that, in the opinion of theInvestigator, would have made the participant unsuitable for the study or unable tocomply with the dosing requirements
Study Design
Connect with a study center
Holdsworth House Medical Practice
Darlinghurst, New South Wales 02010
AustraliaSite Not Available
St Vincent's Hospital, Sydney
Darlinghurst, 02010
AustraliaSite Not Available
Taylor Square Private Clinic
Darlinghurst, 02010
AustraliaSite Not Available
Clinical Research - Infectious Diseases Unit Alfred Hospital
Melbourne, 03004
AustraliaSite Not Available
Northside Clinic
North Fitzroy, 03068
AustraliaSite Not Available
Prahran Market Clinic
Prahran, 03181
AustraliaSite Not Available
Albion Street Centre
Surry Hills, 02010
AustraliaSite Not Available
East Sydney Doctors
Sydney, 02010
AustraliaSite Not Available
LKH Medical University Graz West, Department of Internal Medicine
Graz, A-8020
AustriaSite Not Available
Universitätsklinikum Innsbruck Universitätsklinik für Dermatologie und Venerologie
Innsbruck, A6020
AustriaSite Not Available
Department of Dermatology, Allergy, and Infectious Disease University Vienna Medical School
Vienna, 01090
AustriaSite Not Available
Institute of Tropical Medicine
Antwerp, 2000
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc - UCL
Brussels, 01200
BelgiumSite Not Available
University Hospitals Leuven
Leuven, 03000
BelgiumSite Not Available
Division of HIV/AIDS, St. Paul's Hospital
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia V6Z2C7
CanadaSite Not Available
The Ottawa Hospital, General Campus
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Maple Leaf Research Maple Leaf Medical Clinic
Toronto, Ontario M5G 1K2
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaSite Not Available
University Health Network/Toronto General Hospital
Toronto, Ontario M5G 2N2
CanadaSite Not Available
McGill University Health Center, Montreal Chest Institute
Montreal, Quebec H2X 2P4
CanadaSite Not Available
Clinique médicale L' Actuel
Montréal, Quebec H2L 4P9
CanadaSite Not Available
Clinique médicale L' Actuel
Montréal, Quebec H2L 4P9
CanadaSite Not Available
Hopital Raymond Poincare
Garches, 92380
FranceSite Not Available
Hôpital de la Croix-Rousse
Lyon, 69288
FranceSite Not Available
Chu Hotel Dieu
Nantes, 44093
FranceSite Not Available
CHU Nice - Archet 1
Nice, 06200
FranceSite Not Available
HOSPITAL SAINT LOUIS - Services des Maladies Infectieuses
Paris, 75475
FranceSite Not Available
Hopital Bichat Claude Bernard
Paris, 75018
FranceSite Not Available
Hopital Saint Antoine- Service Maladies infectieuses
Paris, 75571
FranceSite Not Available
Hopital Tenon Service des Maladies infectieuses et tropicales
Paris, 75970
FranceSite Not Available
Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses
Paris cedex 13, 75651
FranceSite Not Available
Centre Hospitalier de Tourcoing
Tourcoing, 59208
FranceSite Not Available
EPIMED GmbH
Berlin, 12157
GermanySite Not Available
Medizinische Universitätsklinik I der Friedrich-Wilhelms Universität Bonn
Bonn, 53105
GermanySite Not Available
Department of Dermatology University Hospital Essen
Essen, 45122
GermanySite Not Available
Private Practice Gute & Locher & Lutz, Infektiologikum
Frankfurt am Main, 60311
GermanySite Not Available
Division of Infectious Disease, Department of Medicine, University Hospital Freiburg
Freiburg, 79106
GermanySite Not Available
ICH Study Center
Hamburg, 20146
GermanySite Not Available
Universitätsklinikum Eppendorf Ambulanzzentrum des UKE GmbH, Infekiologie
Hamburg, 20246
GermanySite Not Available
MUC Research GmbH
München, 80335
GermanySite Not Available
MUC Research GmbH
München, 80335
GermanySite Not Available
Ospedali Riuniti
Bergamo, 24128
ItalySite Not Available
IRCCS Ospedale San Raffaele Centro San Luigi, Unità Operativa di Malattie Infettive
Milan, 20127
ItalySite Not Available
I Div Infectious Diseases, Luigi Sacco Hospital
Milano, 20157
ItalySite Not Available
San Gerardo Hospital - Uo Malattie Infettive
Monza, 20092
ItalySite Not Available
Foundation "IRCCS Policlinico San Matteo Hospital"
Pavia, 27100
ItalySite Not Available
National Institute for Infectious Diseases "L. Spallanzani" IRCCS
Rome, 00149
ItalySite Not Available
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
NetherlandsSite Not Available
Erasmus MC
Rotterdam, PB 2040
NetherlandsSite Not Available
Hospital de Santa Maria - CHLN, EPE
Lisbon, 1649-035
PortugalSite Not Available
Hospital de Joaquim urbano
Porto, 4369-004
PortugalSite Not Available
Serviço de Doenças Infecciosas, Hospital S. Joao
Porto, 4200-319
PortugalSite Not Available
Clinical Research Puerto Rico
San Juan, 00909
Puerto RicoSite Not Available
Hospital General Universitario Alicante
Alicante, 03010
SpainSite Not Available
Hospital Universitari de Bellvitge
Barcelona, 08907
SpainSite Not Available
Hospital Universitari de Bellvitge
Cataluña, 08907
SpainSite Not Available
Hospital Universitario de Elche, Unidad de Enfermedades Infecciosas
Elche, 03202
SpainSite Not Available
Hospital La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitario 12 Octubre
Madrid, 28041
SpainSite Not Available
Unidad HIV. Hospital 12 de Octubre
Madrid, 28041
SpainSite Not Available
Universitätsklinik für Infektiologie
Bern, 03010
SwitzerlandSite Not Available
CHUV
Lausanne, 01011
SwitzerlandSite Not Available
University Hospital Zurich
Zurich, 08091
SwitzerlandSite Not Available
Royal Sussex County Hospital
Brighton, BN2 5BE
United KingdomSite Not Available
Ridu, Wgh
Edinburgh, EH42XU
United KingdomSite Not Available
Chelsea and Westminster Hospital
London, Sw10 9NH
United KingdomSite Not Available
Clinical Research, Grahame Hayton Unit Ambrose King Centre, The Royal London Hospital
London, E11 BB
United KingdomSite Not Available
Guys and St Thomas' NHS trust
London, SE7 4EH
United KingdomSite Not Available
Royal Free NHS Trust,
London, NW32QG
United KingdomSite Not Available
North Manchester General Hospital
Manchester, M8 5RB
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Spectrum Medical Group
Phoenix, Arizona 85012
United StatesSite Not Available
AHF Research Center
Beverly Hills, California 90211
United StatesSite Not Available
Kaiser Permanente Medical Center
Hayward, California 94545
United StatesSite Not Available
Living Hope Education and Research Consultants
Long Beach, California 90813
United StatesSite Not Available
Anthony Mills MD Inc
Los Angeles, California 90069
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center
Los Angeles, California 90028
United StatesSite Not Available
Kaiser Permanente Medical Center
Los Angeles, California 90027
United StatesSite Not Available
Lightsource Medical
Los Angeles, California 90036
United StatesSite Not Available
Oasis Clinic
Los Angeles, California 90059
United StatesSite Not Available
Orange Coast Medical Group
Newport Beach, California 92663
United StatesSite Not Available
East Bay AIDS Center
Oakland, California 94609
United StatesSite Not Available
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Kaiser Permanente Medical Group
Sacramento, California 95825
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 Medical Center, San Francisco
San Francisco, California 94118
United StatesSite Not Available
Metropolis Medical/Dr.Fritz
San Francisco, California 94114
United StatesSite Not Available
Apex Research LLC
Denver, Colorado 80209
United StatesSite Not Available
Capital Medical Associates, PC
Washington, District of Columbia 20036
United StatesSite Not Available
Dupont Circle Physician's Group
Washington, District of Columbia 20009
United StatesSite Not Available
Medical Faculty Associates
Washington, District of Columbia 20037
United StatesSite Not Available
Whitman-Walker Clinic
Washington, District of Columbia 20009
United StatesSite Not Available
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida 33316
United StatesSite Not Available
Midway Immunology and Research Center
Fort Pierce, Florida 34982
United StatesSite Not Available
Broward General Medical Center
Ft. Lauderdale, Florida 33311
United StatesSite Not Available
The Kinder Medical Group
Miami, Florida 33133
United StatesSite Not Available
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida 33139
United StatesSite Not Available
Orlando Immunology Center
Orlando, Florida 32803
United StatesSite Not Available
Valuhealthmd,Llc / Idocf
Orlando, Florida 32806
United StatesSite Not Available
Infectious Disease Associates of NW FL
Pensacola, Florida 32504
United StatesSite Not Available
AHF Health Positive - Tampa Bay
Safety Harbor, Florida 34695
United StatesSite Not Available
St. Joseph's Hospital d/b/a Comprehensive Research Institute
Tampa, Florida 33614
United StatesSite Not Available
AIDS Research Consortium of Atlanta
Atlanta, Georgia 30308
United StatesSite Not Available
Atlanta ID Group
Atlanta, Georgia 30309
United StatesSite Not Available
Emory University
Atlanta, Georgia 30306
United StatesSite Not Available
Infectious Disease Specialists of America
Decatur, Georgia 30033
United StatesSite Not Available
Mercer University School of Medicine
Macon, Georgia 31201
United StatesSite Not Available
Clint Spencer Clinic
Honolulu, Hawaii 96813
United StatesSite Not Available
Howard Brown Health Center
Chicago, Illinois 60613
United StatesSite Not Available
Northstar Medical Center
Chicago, Illinois 60657
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station
Lutherville, Maryland 21093
United StatesSite Not Available
Community Research Initiative of New England
Boston, Massachusetts 02111
United StatesSite Not Available
Claudia T Martorell, MD., LLC dba The Research Institute
Springfield, Massachusetts 01105
United StatesSite Not Available
Be Well Medical Center
Berkley, Michigan 48072
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United StatesSite Not Available
Central West Clinical Research, Inc.
St. Louis, Missouri 63108
United StatesSite Not Available
Southampton Healthcare
St. Louis, Missouri 63139
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
Southwest Care Center
Sante Fe, New Mexico 87505
United StatesSite Not Available
Upstate Infectious Disease Associates
Albany, New York 12208
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
New York Hospital Queens
Flushing, New York 11355
United StatesSite Not Available
North Shore University Hospital--Division of Infectious Diseases
Manhasset, New York 11030
United StatesSite Not Available
Greiger Clinic
Mount Vernon, New York 10550
United StatesSite Not Available
Beth Israel Medical Center
New York, New York 10003
United StatesSite Not Available
Ricky K. Hsu, Md, Pc
New York, New York 10011
United StatesSite Not Available
Clinical and Translational Research Center - UNC Hospitals
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Carolinas Medical Center
Charlotte, North Carolina 28207
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
The Brody School of Medicine at East Carolina University
Greenville, North Carolina 27834
United StatesSite Not Available
Rosedale Infectious Diseases
Huntersville, North Carolina 28078
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Summa Health System Care Center
Akron, Ohio 44203
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Philadelphia FIGHT
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of South Carolina
Columbia, South Carolina 29223
United StatesSite Not Available
Central Texas Clinical Research
Austin, Texas 78705
United StatesSite Not Available
Southwest Infectious Disease Associates, Inc.
Dallas, Texas 75219
United StatesSite Not Available
Trinity Health and Wellness Center
Dallas, Texas 75208
United StatesSite Not Available
Tarrant County Infectious Disease Associates
Fort Worth, Texas 76104
United StatesSite Not Available
Garcia Family Health Group
Harlingen, Texas 78550
United StatesSite Not Available
Gordon E. Crofoot MD PA
Houston, Texas 77098
United StatesSite Not Available
Therapeutic Concepts, P.A.
Houston, Texas 77004
United StatesSite Not Available
DCOL Center for Clinical Research
Longview, Texas 75605
United StatesSite Not Available
CARE-ID
Annandale, Virginia 22003
United StatesSite Not Available
Peter Shalit, M.D.
Seattle, Washington 98104
United StatesSite Not Available
Rockwood Pulmonary and Critical Care
Spokane, Washington 99204
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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