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

Running, not enrolling · Phase 1

Conditions studied: HIV Infection

In brief

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).

Key facts

Study ID

NCT04340596

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

118

Starts

2021-05-21

Expected to finish

2026-12-30

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection
• On ART for at least 96 weeks prior to randomization
• On ART regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization.
• CD4 cell count >450 cells/mm\^3 within 90 days prior to randomization
• CD4 cell count nadir ≥200 cells/mm\^3.
• Plasma HIV-1 RNA levels of <50 copies/mL for at least 96 weeks prior to randomization
• Select laboratory results within 90 days of randomization
• IC90 to 10-1074 of ≤1.5 mcg/mL, 10-1074 maximum percent inhibition (MPI) ≥98%, and IC80 to VRC07-523LS of ≤1 mcg/mL on the Monogram PhenoSense assay.
• QTcF interval ≤440 msec within 90 days prior to randomization.
• For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 30 days prior to randomization
• Cisgender women and transgender men of reproductive potential must agree to use two methods of contraception, if participating in sexual activity that could lead to pregnancy.
• Cisgender men and transgender women participants engaging in sexual activity that could lead to pregnancy and who are of reproductive potential must agree to use a barrier method of contraception
• Willingness to abstain from sexual intercourse or use a barrier method of contraception consistently
• Willingness to participate in an ATI.
• Weight >50 kg and <115 kg.
• Completion of pre-entry leukapheresis

You may not qualify if…

• History of AIDS-defining illness, with the exception of recurrent pneumonia.
• History of or current clinical cardiovascular disease
• Current clinically significant acute or chronic medical condition
• History of HIV-associated neurocognitive disease
• History of an HIV-associated malignancy
• ART initiated during acute HIV infection
• Current receipt of ART other than NRTI and integrase inhibitor.
• Resistance to one or more drugs in two or more ARV drug classes.
• Receipt of any therapeutic HIV vaccine or monoclonal antibody therapy (anti-HIV or otherwise) at any time in the past.
• History of prior immunoglobulin (IgG) therapy.
• History of use of any immunomodulatory medications within 6 months prior to randomization
• Participation in another clinical study of an investigational product currently or within past 12 weeks
• Breastfeeding or pregnancy

Where it is running

• 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

Full record on ClinicalTrials.gov

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