Interleukin-15 to Promote Post-ART Control of HIV

Conditions

• HIV

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• N-803 — DRUG
  This is the active drug.
• Saline placebo — DRUG
  This is the placebo.

Study Details

Even though HIV medicine stops the virus from making more copies of itself, the virus remains in the body by hiding inside of immune cells. This hidden virus is referred to as the "latent reservoir." Researchers on this team are studying whether stimulating the immune system can change the nature of the latent reservoir and if this could help people control HIV without the need to take regular HIV medicine. This study is testing a drug called N-803. N-803 is also known as Interleukin-15 or "IL-15", a powerful and long lasting protein that can affect the immune system by stimulating immune cells such as CD8+ T cells and natural killer (NK) cells. CD8+ T cells and NK cells are both crucial for eliminating infected cells. The drug is FDA-approved for the treatment of bladder cancer, but in this study the drug is being used experimentally for HIV.

Key Dates

Start date

Aug 19, 2025

Status verified

Jan 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: N-803
  Participants in this arm will receive the active study drug during the blinded portion (Phase A) of the trial. They will receive the active study drug during the open-label portion (Phase B) of the trial.
• Placebo Comparator: Placebo
  Participants in this arm will receive placebo during the blinded portion (Phase A) of the trial. They will receive the active study drug during the open-label portion (Phase B) of the trial.

Primary Outcome Measure

Safety - Solicited Adverse Events [ Time Frame: Within 7 days after dosing. ]

Locations (1)

Find similar trials in San Francisco, CA

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