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
Receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIscontinuously for ≥ 6 months preceding the screening visit
Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 6 months prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screeningvisit
On their first or second antiretroviral drug regimen; if on their second regimen,HIV-1 RNA ≤ 50 copies/mL required at the time of the first change in antiretroviraldrugs, and no HIV RNA > 50 copies/mL measured at two consecutive time points afterfirst achieving HIV RNA < 50 copies/mL
No previous use of any approved or experimental nonnucleoside reverse transcriptaseinhibitor (NNRTI) drug for any length of time
Have a genotype prior to starting initial antiretroviral therapy and no knownresistance to any of the study agents
Normal 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 (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN eligible if serumlipase ≤ 5 x ULN)
Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according tothe Cockcroft-Gault formula)
Males and females of childbearing potential must agree to utilize highly effectivecontraception methods (two separate forms of contraception, one of which must havebeen an effective barrier method, or been nonheterosexually active, practice sexualabstinence, or have a vasectomized partner) from screening throughout the duration ofthe study period and for 30 days following the last dose of study drug.
Age ≥ 18 years
Life expectancy ≥ 1 year
Exclusion
Exclusion Criteria:
A new AIDS-defining condition diagnosed within 30 days prior to screening exceptcluster of differentiation 4 (CD4) cell count and/or percentage criteria
Females who are breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Proven or suspected acute hepatitis 30 days prior to study entry.
Current alcohol or substance abuse judged by the Investigator to potentially interferewith subject compliance.
History of malignancy within 5 years prior to study entry or ongoing malignancy otherthan cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasivecutaneous squamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapywithin 30 days prior to baseline
Anticipated need to initiate contraindicated drugs during the study, including drugsnot to be used with FTC, TDF, RPV; or subjects with known allergies to the excipientsof FTC/RPV/TDF STR tablets or Truvada® tablets
All investigational drugs
Medications and use of herbal/natural supplements excluded or to be used with cautionwhile participating in the study, including those not to be taken with Viread®,Emtriva®, Truvada, and Rilpivirine.
Participation in any other clinical trial without prior approval from the sponsor wasprohibited while participating in this trial
Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 monthsof study screening, or expected to receive these agents or systemic steroids duringthe study
History of liver disease, including Gilbert's Disease
Any other clinical condition or prior therapy making the subject unsuitable for thestudy or unable to comply with the dosing requirements
Study Design
Connect with a study center
Univ.-Kklinik fuer Innere Medizin III
Salzberg,
AustriaSite Not Available
LKH Graz West
Styria,
AustriaSite Not Available
2.Interne Lungenabteilung Otto Wagner Spital
Vienna,
AustriaSite Not Available
Dept. of Dermatology, Div. of Immunology,
Vienna,
AustriaSite Not Available
Private Office
Vienna,
AustriaSite Not Available
CHU Saint-Pierre University Hospital
Brussels, 1000
BelgiumSite Not Available
University Hospitals Leuven
Flemish Brabant,
BelgiumSite Not Available
Universitaire Ziekenhuis Gent
Ghent, 9000
BelgiumSite Not Available
Downtown Infectious Disease Clinic - Univ of BC
Vancouver, British Columbia
CanadaSite Not Available
Maple Leaf Research
Toronto, Ontario
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario
CanadaSite Not Available
Clinique Medicale Du Quartier Latin
Montreal, Quebec H2L 5B1
CanadaSite Not Available
Winnipeg Regional Health Authority
Winnipeg,
CanadaSite Not Available
Hôpital Hôtel-Dieu
Lyon, 69002
FranceSite Not Available
Infectiologie - 7ème Ouest - CHU HOTEL DIEU
Nantes,
FranceSite Not Available
Archet 1 CHU de Nice - 6ème Niveau - Infectiology
Nice Cedex 3, 06202
FranceSite Not Available
Bichat Hospital
Paris, 75018
FranceSite Not Available
Department of Infectious Diseases, Saint-Louis hospital
Paris, 75010
FranceSite Not Available
Hopital Tenon
Paris,
FranceSite Not Available
Hôpital Saint Antoine, Servuce de Maladies Infectieuses
Paris, 75012
FranceSite Not Available
Maladies Infectieuses Dpt
Paris,
FranceSite Not Available
Hôpital Haut Levêque
Pessac,
FranceSite Not Available
EPIMED GmbH
Berlin, 12157
GermanySite Not Available
University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic
Bonn, 53127
GermanySite Not Available
Center for HIV and Hepatogastroenterology
Dusseldorf,
GermanySite Not Available
Infectio Research
Frankfurt, 60596
GermanySite Not Available
ICH Study Center Hamburg
Hamburg, 20146
GermanySite Not Available
University Medical Center Hamburg - Eppendorf
Hamburg,
GermanySite Not Available
University of Cologne, Department of Internal Medicine
Köln, 50937
GermanySite Not Available
University of Cologne, Department of Internal Medicine
Köln, 50937
GermanySite Not Available
Ospedali Riuniti
Bergamo, 24128
ItalySite Not Available
Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive
Milan, 20157
ItalySite Not Available
Azienda Ospedaliera San Paolo, Mallattie Infettive e Tropicali
Milan, 20142
ItalySite Not Available
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20127
ItalySite Not Available
National Institute for Infectious Diseases "L. Spallanzani" IRCCS
Rome, 20149
ItalySite Not Available
Clinical Research Puerto Rico, Inc.
San Juan, 00909
Puerto RicoSite Not Available
Hospital Clinic i Provincial
Barcelona, 28036
SpainSite Not Available
Hospital Germans Trias i Pujol
Barcelona, 28916
SpainSite Not Available
Hospital General Universitario Gregorio Marañon
Madrid, 28007
SpainSite Not Available
Hospital Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex BN2 1ES
United KingdomSite Not Available
Barts and the London NHS Trust
London, E1 1BB
United KingdomSite Not Available
Chelsea and Westminster Hospital Foundation Trust
London, SW10 9NH
United KingdomSite Not Available
Homerton Unversity Hospital
London,
United KingdomSite Not Available
Royal Free Hospital
London, NW3 2QG
United KingdomSite Not Available
North Manchester General Hospital
Manchester, M85RB
United KingdomSite Not Available
University of Alabama - Birmingham
Birmingham, Alabama 35294
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-Research Center
Beverly HIlls, California 90211
United StatesSite Not Available
Pacific Oaks Medical Group
Beverly Hills, California
United StatesSite Not Available
Center for Special Immunology
Costa Mesa, California 92626
United StatesSite Not Available
Kaiser Permanente
Hayward, California 94545
United StatesSite Not Available
The Living Hope Foundation
Long Beach, California 90813
United StatesSite Not Available
Anthony Mills, MD Internal Medicine
Los Angeles, California 90069
United StatesSite Not Available
Jeffrey Goodman Special Care Clinic
Los Angeles, California 90028
United StatesSite Not Available
Kaiser Permanente
Los Angeles, California 90027
United StatesSite Not Available
Oasis Clinic
Los Angeles, California 90059
United StatesSite Not Available
Peter J. Ruane, MD, Inc.
Los Angeles, California 90019
United StatesSite Not Available
Orange Coast Medical Group
Newport Beach, California 92663
United StatesSite Not Available
Alameda County Medical Center
Oakland, California 94602
United StatesSite Not Available
East Bay AIDS Center
Oakland, California 94609
United StatesSite Not Available
Stanford University
Palo Alto, California 94303
United StatesSite Not Available
Kaiser Permanente
Sacramento, California 95825
United StatesSite Not Available
University of California, Davis
Sacramento, California 95187
United StatesSite Not Available
La Playa Medical Group and Clinical Research
San Diego, California 92103
United StatesSite Not Available
Kaiser Permanente
San Francisco, California 94118
United StatesSite Not Available
Metropolis Medical
San Francisco, California 94115
United StatesSite Not Available
Capital Medical Associates PC
Washington, District of Columbia 20036
United StatesSite Not Available
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida 33316
United StatesSite Not Available
Midway Immunology & Research Center
Fort Pierce, Florida 34982
United StatesSite Not Available
Care Resource
Miami, Florida
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
ValueHealthMD, LLC/IDOCF
Orlando, Florida 32806
United StatesSite Not Available
Wade, Barbara Private Practice
Pensacola, Florida 32504
United StatesSite Not Available
Barry M. Rodwick, M.D.
Safety Harbor, Florida 34695
United StatesSite Not Available
St. Joseph's Comprehensive Research Institute
Tampa, Florida 33614
United StatesSite Not Available
University of South Florida - HIV Clinical Research Unit
Tampa, Florida 33062
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
Infectious Disease Specialists of Atlanta (IDSA)
Decatur, Georgia 30033
United StatesSite Not Available
Mercer Univ. School of Medicine
Macon, Georgia 31201
United StatesSite Not Available
Northstar Medical Center
Chicago, Illinois 60657
United StatesSite Not Available
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United StatesSite Not Available
The Ruth M. Rothstein CORE Center
Chicago, Illinois 60612
United StatesSite Not Available
Johns Hopkins University School of Medicine
Lutherville, Maryland 21093
United StatesSite Not Available
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
The Research Institute
Springfield, Massachusetts 01105
United StatesSite Not Available
Be Well Medical Center
Berkley, Michigan 48072
United StatesSite Not Available
Henry Ford Hospital Div of Infectious Disease
Detroit, Michigan 48202
United StatesSite Not Available
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United StatesSite Not Available
Kansas City Free Health Clinic
Kansas City, Missouri
United StatesSite Not Available
Southampton Healthcare, Inc.
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
Somer Point, New Jersey 08244
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
Mt Vernon, New York
United StatesSite Not Available
Beth Israel Medical Center
New York, New York 10003
United StatesSite Not Available
The Aaron Diamond AIDS Research Center
New York, New York 10016
United StatesSite Not Available
ID Consultant, P.A.
Charlotte, North Carolina 28209
United StatesSite Not Available
Duke University Health System, Division of Infectious Disease Clinic 2J
Durham, North Carolina 27710
United StatesSite Not Available
East Carolina University, The Brody School of Medicine
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 CARE Center
Akron, Ohio 44304
United StatesSite Not Available
Philadelphia FIGHT
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of South Carolina
Columbia, South Carolina 29203
United StatesSite Not Available
Central Texas Clinical Research
Austin, Texas 78705
United StatesSite Not Available
Nicholaos Bellos, MD, PA
Dallas, Texas 75204
United StatesSite Not Available
Tarrant County Infectious Diseases Associates
Fort Worth, Texas 76104
United StatesSite Not Available
Garcia Family Medical Clinic
Harlingen, Texas 78550
United StatesSite Not Available
Gordon E. Crofoot, MD, PA
Houston, Texas 77098
United StatesSite Not Available
Research Access Network
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
Clinical Alliance for Research & Education-Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia 22003
United StatesSite Not Available
TribalMed
Seattle, Washington 98104
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.