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Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
Official title: A Phase I Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2021-05-21
Completion Date
2026-12-30
Last Updated
2025-03-25
Healthy Volunteers
No
Conditions
Interventions
N-803 (IL-15 Superagonist)
Administered by subcutaneous (SQ) injection
VRC07-523LS
Administered by intravenous (IV) infusion
10-1074
Administered by intravenous (IV) infusion
Locations (14)
Alabama CRS (Site ID# 31788)
Birmingham, Alabama, United States
UCLA CARE Center CRS
Los Angeles, California, United States
UCSD Antiviral Research Center CRS (Site ID: 701)
San Diego, California, United States
University of California, San Fransisco HIV/AIDS CRS
San Francisco, California, United States
Whitman-Walker Institute, Inc. CRS (Site ID: 31791)
Washington D.C., District of Columbia, United States
Northwestern University CRS
Chicago, Illinois, United States
Massachusetts General Hospital CRS (MGH CRS) (Site ID: 101)
Boston, Massachusetts, United States
Washington University Therapeutics (WT) CRS
St Louis, Missouri, United States
New Jersey Medical School Clinical Research Center CRS [Site ID: 31786]
Newark, New Jersey, United States
Columbia P&S CRS
New York, New York, United States
Weill Cornell Uptown CRS (Site ID: 7803)
New York, New York, United States
Chapel Hill CRS (Site ID: 3201)
Chapel Hill, North Carolina, United States
Case Clinical Research Site
Cleveland, Ohio, United States
Penn Therapeutics, CRS (Site ID: 6201)
Philadelphia, Pennsylvania, United States