Phase
Condition
Hiv Infections
Treatment
Lenacapavir Injection
Lenacapavir Tablet
Teropavimab
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
On stable oral antiretroviral therapy (ART) consisting of no more than 2 drugclasses (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior toscreening visit 2 for reasons other than virologic failure (VF) (eg, tolerability,simplification, drug-drug interaction profile) is allowed.
No clinically significant documented historical resistance to the current ARTregimen with the exception of isolated nucleoside reverse transcriptase inhibitormutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R,L210W, T215Y, and/or K219Q).
Plasma HIV-1 RNA < 50 copies/mL at screening visit 2.
Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if thelimit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.
Proviral pheynotypic sensitivity to both teropavimab and zinlirvimab at screening orfrom protocol GS-US-536-5816 within 24 months prior to screening.
Screening CD4+ T-cell count ≥ 200 cells/μL at screening visit 2.
Exclusion
Key Exclusion Criteria:
Comorbid condition requiring ongoing immunosuppression.
Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneouslyor with treatment is acceptable)
Evidence of current hepatitis B virus (HBV) infection regardless of HBV surfaceantigen status, at the screening visit 2.
History of opportunistic infection or illness indicative of Stage 3 HIV disease.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
East Sydney Doctors
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Holdsworth House Medical Practice
Sydney, New South Wales 2010 NSW
AustraliaSite Not Available
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
CMU Quartier Latin Inc
Montreal, H2L 0B1
CanadaSite Not Available
The Ottawa Hospital - General Campus
Ottawa, K1H 8L6
CanadaSite Not Available
Maple Leaf Research/Maple Leaf Medical Clinic
Toronto, M5G 1K2
CanadaSite Not Available
University Health Network - Toronto General Hospital
Toronto, M5G 2N2
CanadaActive - Recruiting
Clinical Research Puerto Rico
San Juan, 909
Puerto RicoSite Not Available
Be Well Medical Center
Berkeley, California 48072
United StatesSite Not Available
Mills Clinical Research
Los Angeles, California 90069
United StatesSite Not Available
Ruane Clinical Research Group, Inc.
Los Angeles, California 90036
United StatesSite Not Available
UC San Diego (UCSD) AntiViral Research Center (AVRC)
San Diego, California 92103
United StatesSite Not Available
Optimus Medical Group
San Francisco, California 94102
United StatesSite Not Available
University of Colorado Clinical and Translational Research Center
Aurora, Colorado 80045
United StatesSite Not Available
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut 06510
United StatesSite Not Available
Georgetown University Medical Center
Washington, District of Columbia 20007
United StatesSite Not Available
Midland Florida Clinical Research Center, LLC
DeLand, Florida 32720
United StatesSite Not Available
Can Community Health Care
Fort Lauderdale, Florida 33316
United StatesSite Not Available
Midway Immunology and Research Center
Fort Pierce, Florida 34982
United StatesSite Not Available
Orlando Immunology Center
Orlando, Florida 32803
United StatesSite Not Available
Triple O Research Institute, P.A.
West Palm Beach, Florida 33407
United StatesSite Not Available
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia 30308
United StatesSite Not Available
Infectious Disease Specialists of Atlanta
Decatur, Georgia 30033
United StatesSite Not Available
Be Well Medical Center
Berkley, Michigan 48072
United StatesSite Not Available
Southhampton Healthcare, Inc
Saint Louis, Missouri 63139
United StatesSite Not Available
ID Care, P.A.
Hillsborough, New Jersey 08844
United StatesSite Not Available
AXCES Research Group, LLC
Albuquerque, New Mexico 87109
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Duke University Health Center
Durham, North Carolina 27710
United StatesSite Not Available
Regional Center for Infectious Disease Research
Greensboro, North Carolina 27401
United StatesSite Not Available
The Brody School of Medicine at East Carolina University
Greenville, North Carolina 27858
United StatesSite Not Available
Rosedale Health and Wellness
Huntersville, North Carolina 28078
United StatesSite Not Available
Prisma Health - Clinical Research Unit
Columbia, South Carolina 29203
United StatesSite Not Available
St Jude Children's Research Hospital
Memphis, Tennessee 38105
United StatesSite Not Available
Central Texas Clinical Research
Austin, Texas 78705
United StatesSite Not Available
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas 75208
United StatesSite Not Available
North Texas Infectious Diseases Consultant's, P.A.
Dallas, Texas 75246
United StatesActive - Recruiting
AXCES Research Group, LLC
El Paso, Texas 79902
United StatesSite Not Available
The Crofoot Research Center, INC
Houston, Texas 77098
United StatesSite Not Available
Clinical Alliance for Research & Education, Infectious Diseases LLC (CARE-ID)
Annandale, Virginia 22003
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.