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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

Clinical Trial Details

The purpose of this study is to investigate the following:

  • If a new immune stimulating experimental drug, N-803, is safe and tolerable
  • If a combination of N-803 and two new experimental drugs that are antibodies to HIV, VRC07-523LS and 10-1074, is safe and tolerable
  • How well HIV is controlled after stopping ART in persons who received N-803 alone compared to N-803 with VRC07-523LS and 10-1074

This study involves study treatment with N-803 alone or in combination with VRC07-523LS and 10-1074. N-803 is an immune stimulating experimental drug that binds to the interleukin 15 (also known as “IL-15”) receptor. IL-15 is a naturally occurring substance produced by the body to stimulate cells of the immune system to increase in number and become more active. VRC07-523LS and 10-1074 are antibodies to HIV and are also experimental drugs. Antibodies are one of the ways the human body fights infection. Antibodies are natural proteins that the body can make to prevent infectious agents such as bacteria and viruses from making you sick. Researchers can also make antibodies in laboratories and give them to people through a vein (with an IV). These antibodies attach to HIV and can block HIV from attacking cells in the body and from spreading to other parts of the body. These antibodies are being developed to potentially treat and prevent HIV infection.

Key Eligibility: 
  • Open to people living with HIV between the ages of 18 and 65 years old, who have been on ART for at least 96 weeks prior to randomization
  • Participants must not have a current clinically significant acute or chronic medical condition

    Detailed eligibility will be reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Jonathan Berardi, NP
212-746-4177
jlb4002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2104023543

ClinicalTrials.gov:

NCT04340596

Sponsor:

A5386

Status

Open to Enrollment

Age Group

Adult

Sponsor