Phase
Condition
N/ATreatment
Antiretroviral Combinations
ISL/LEN
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
One HIV-1 RNA < 50 copies/mL immediately preceding the 24 weeks period prior toscreening.
Within 24 weeks prior to screening, if HIV-1 RNA results are available, alllevels must be < 50 copies/mL.
During the 6 to 12 months period prior to screening, transient detectableviremia ≥ 50 copies/mL is acceptable ("blip") as long as it is not confirmed on 2 consecutive visits.
Plasma HIV-1 RNA levels < 50 copies/mL at screening.
Are receiving guideline-recommended standard of care treatment such as InternationalAntiviral Society (IAS), Department of Health and Human Services (DHHS), EuropeanAIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior toscreening and willing to continue until Day 1. Individuals in Treatment Group 2 mustalso be willing to continue their standard of care through at least Week 96.
Individuals assigned female at birth and of childbearing potential who engage inheterosexual intercourse must agree to use protocol-specified methods ofcontraception.
Exclusion
Key Exclusion Criteria:
Prior virologic failure.
Prior use of, or exposure to, ISL or LEN.
Active, serious infections requiring parenteral therapy within 30 days beforerandomization.
Active tuberculosis infection.
Acute hepatitis within 30 days before randomization.
Hepatitis B virus (HBV) infection, as determined below at the screening visit:
positive HBV surface antigen OR
positive HBV core antibody and negative HBV surface antibody. Note: individualsfound to be susceptible to HBV infection (eg negative hepatitis B surfaceantibody at the screening visit, regardless of prior HBV vaccination history)should be recommended to receive HBV vaccination.
Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note:individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) maybe enrolled.
Any of the following laboratory values at screening:
Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gaultformula
Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN)
Direct bilirubin > 1.5 x ULN
Platelets < 50,000/μL
Hemoglobin < 8.0 g/dL
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Fundacion Huesped
Buenos Aires, 1202
ArgentinaActive - Recruiting
East Sydney Doctors
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
St Vincent's Hospital
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Taylor Square Private Clinic
Darlinghurst, New South Wales 2011
AustraliaActive - Recruiting
Taylor Square Private Clinic
Surry Hills, New South Wales 2010
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria 3168
AustraliaActive - Recruiting
Prahran Market Clinic
South Yarra, Victoria 3141
AustraliaActive - Recruiting
University Hospital Hannover, Department for Rheumatology and Immunology
Hannover, 30625
GermanyActive - Recruiting
Dr. Scholten & Schneeweiß GbR
Köln, 50674
GermanyActive - Recruiting
Mannheimer Onkologie Praxis
Mannheim, 68167
GermanyActive - Recruiting
MVZ München am Goetheplatz, MUC Research GmbH
Munchen, 80337
GermanyActive - Recruiting
Chiba University Hospital
Chiba,
JapanActive - Recruiting
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001
JapanActive - Recruiting
University of the Ryukyus Hospital
Okinawa,
JapanActive - Recruiting
National Hospital Organization Osaka National Hospital
Osaka Fu, 540-0006
JapanActive - Recruiting
Osaka City General Hospital
Osaka-City, 534-0021
JapanActive - Recruiting
National Center for Global Health and Medicine
Tokyo, 162-8655,
JapanActive - Recruiting
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanActive - Recruiting
Amsterdam UMC, Iocation AMC
Amsterdam, 1105 az
NetherlandsActive - Recruiting
HOPE Clinical Research
San Juan, 00909
Puerto RicoActive - Recruiting
Maternal Infant Studies Center(CEMI)
San Juan, 00936-5067
Puerto RicoActive - Recruiting
Perinatal HIV Research Unit
Soweto, 2013
South AfricaActive - Recruiting
Hospital Germans Trias I Pujol
Barcelona, 08916
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainActive - Recruiting
Inselspital, Freiburgstrasse 20. Bern
Bern, 3010
SwitzerlandActive - Recruiting
Hopitaux Universitaires de Geneve
Geneva, 1205
SwitzerlandActive - Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
SwitzerlandActive - Recruiting
Kaohsiung Medical University Hospital
Kaohsiung, 80756
TaiwanActive - Recruiting
Far Eastern Memorial Hospital
New Taipei City, 22060
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei City, 10002
TaiwanActive - Recruiting
Taoyuan General Hospital
Taoyuan City, 33004
TaiwanActive - Recruiting
Siriraj Hospital
Bangkok, 10700
ThailandActive - Recruiting
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research
Bangkok, 10330
ThailandActive - Recruiting
Chiang Mai University
Chiang Mai, 50200
ThailandActive - Recruiting
Khon Kaen University
Khon Kaen, 40002
ThailandActive - Recruiting
Bamrasnaradura Infectious Disease Institute
Nonthaburi, 11000
ThailandActive - Recruiting
Institute of HIV Research and Innovation (IHRI)
Pathumwan, 10330
ThailandActive - Recruiting
Clinical Research Facility -University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 3EW
United KingdomActive - Recruiting
Caldecot Centre, King's College Hospital (King's College Hospital NHS Foundation Trust)
London, SE5 9RJ
United KingdomActive - Recruiting
Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust)
London, E1 1BB.
United KingdomActive - Recruiting
Mortimer Market Centre (Central and North West London NHS Foundation Trust)
London, WC1E 6JB
United KingdomActive - Recruiting
Royal Free Hospital (Royal Free London NHS Foundation Trust)
London, NW3 2QG
United KingdomActive - Recruiting
University of Alabama at Birmingham(UAB) 1917 Research Clinic
Birmingham, Alabama 35294
United StatesActive - Recruiting
Pueblo Family Physicians
Phoenix, Arizona 85015
United StatesActive - Recruiting
Ruane Clinical Research Group
Los Angeles, California 90036
United StatesActive - Recruiting
Vv-Tmf-5366229
Los Angeles, California 90027
United StatesActive - Recruiting
BIOS Clinical Research
Palm Springs, California 92262
United StatesActive - Recruiting
University of Colorado Clinical and Translational Research Center
Denver, Colorado 80262
United StatesActive - Recruiting
Vivent Health
Denver, Colorado 80246
United StatesActive - Recruiting
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut 06510
United StatesActive - Recruiting
Georgetown University Medical Center
Washington, District of Columbia 20007
United StatesActive - Recruiting
Aids Healthcare Foundation - Northpoint
Fort Lauderdale, Florida 33308
United StatesActive - Recruiting
Midway Immunology and Research Center
Fort Pierce, Florida 34982
United StatesActive - Recruiting
CAN Community Health
Miami Gardens, Florida 33055
United StatesActive - Recruiting
Orlando Immunology Center
Orlando, Florida 32803
United StatesActive - Recruiting
AHF Pensacola
Pensacola, Florida 32503
United StatesActive - Recruiting
CAN Community Health
Sarasota, Florida 34237
United StatesActive - Recruiting
BayCare Health System, Inc./St. Joseph's Hospital
Tampa, Florida 33607
United StatesActive - Recruiting
Triple O Research Institute, P.A.
West Palm Beach, Florida 33401
United StatesActive - Recruiting
Metro Infectious Disease Consultants, P.L.L.C.
Decatur, Georgia 30033
United StatesActive - Recruiting
Mercer University, Department of Internal Medicine
Macon, Georgia 31201
United StatesActive - Recruiting
Chatham County Health Department
Savannah, Georgia 31401
United StatesActive - Recruiting
Howard Brown Health Center
Chicago, Illinois 60613
United StatesActive - Recruiting
Indiana CTSI Clinical Research Center
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Boston Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Brigham and Womens's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Community Research Initiative of New England d/b/a Community Resource Initiative (CRI)
Boston, Massachusetts 02129
United StatesActive - Recruiting
Be Well Medical Center
Berkley, Michigan 48072
United StatesActive - Recruiting
Henry Ford Health
Detroit, Michigan 48202
United StatesActive - Recruiting
Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
ID Care
Hillsborough, New Jersey 08844
United StatesActive - Recruiting
Saint Michael's Medical Center
Newark, New Jersey 07102
United StatesActive - Recruiting
AXCES Research Group, LLC
Santa Fe, New Mexico 87505
United StatesActive - Recruiting
Jacobi Medical Center
Bronx, New York 10461
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
NewYork-Presbyterian Queens
Flushing, New York 11355
United StatesActive - Recruiting
Duke University Health System(DUHS)
Durham, North Carolina 27710
United StatesActive - Recruiting
ECU Health Leo Jenkins Cancer Building
Greenville, North Carolina 27834
United StatesActive - Recruiting
Rosedale Health and Wellness
Huntersville, North Carolina 28078
United StatesActive - Recruiting
University of Cincinnati College of Medicine
Cincinnati, Ohio 45267
United StatesActive - Recruiting
Prisma Health Midlands - Clinical Research Unit
Columbia, South Carolina 29203
United StatesActive - Recruiting
Central Texas Clinical Research
Austin, Texas 78705
United StatesActive - Recruiting
North Texas Infectious Diseases Consultants, PA
Dallas, Texas 75246
United StatesActive - Recruiting
AXCES Research Group, LLC
El Paso, Texas 79902
United StatesActive - Recruiting
Texas Centers for Infectious Disease Associates
Fort Worth, Texas 76104
United StatesActive - Recruiting
The Crofoot Research Center, INC.
Houston, Texas 77098
United StatesActive - Recruiting
Clinical Alliance for Research& Education - Infectious Diseases, LLC (CARE-ID)
Longview, Texas 75605
United StatesActive - Recruiting
AXCES Research Group, LLC
Salt Lake City, Utah 84102
United StatesActive - Recruiting
Clinical Alliance for Research& Education - Infectious Diseases, LLC
Annandale, Virginia 22003
United StatesActive - Recruiting
MultiCare Rockwood Main Clinic
Spokane, Washington 99202
United StatesActive - Recruiting
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