Interleukin-15 to Promote Post-ART Control of HIV

NCT07145164 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: 25-44404
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV; IL-15; N-803; Anktiva

Outcome Measures

Primary Outcomes (2)

• Safety - Solicited Adverse Events

  Frequency and grade of each solicited systemic reactogenicity AE (malaise, participant-measured body temperature, fatigue, headache, chills, nausea, muscle aches/pain, joint pain).

  Within 7 days after dosing.

• Safety - Unsolicited Adverse Events

  Frequency and grade of unsolicited AEs.

  Within 7 days after dosing.

Secondary Outcomes (1)

• Time to Rebound

  52 weeks after treatment interruption.

Study Arms (2)

N-803

EXPERIMENTAL

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.

Drug: N-803

Placebo

PLACEBO COMPARATOR

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.

Drug: Saline placebo

Interventions

N-803 DRUG

This is the active drug.

N-803

Saline placebo DRUG

This is the placebo.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 70 years at the time of screening
• Documented HIV-1 infection
• On continuous ART for at least 6 months without any interruptions of greater than 14 consecutive days within the preceding 6 months
• Plasma HIV RNA levels less than 200 copies/mL at each determination in the previous 6 months
• Screening CD4+ T-cell count ≥ 350 cells/mm3
• Willingness to interrupt ART as part of the study transient treatment interruption

You may not qualify if:

• On an ART regimen that includes a non-nucleoside reverse transcriptase inhibitor, unable to switch to a different regimen
• Receipt of any long-acting ART medication (e.g., injectable cabotegravir/rilpivirine, lenacapavir) in the two years preceding screening.
• Known resistance to two or more classes of ART drugs and/or the inability to construct another fully suppressive regimen
• Evidence of HIV "elite" control immediately prior to ART initiation
• Screening platelets \< 125,000/mm3
• Screening hemoglobin \< 12.5 g/dL for men and \<11.5 for women
• History of an AIDS-defining illness according to CDC criteria
• History of HIV-associated malignancy
• Non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the 36 months preceding screening, or for whom such therapies are expected in the subsequent 12 months.
• Active Hepatitis B (Hep B) infection (defined as Hep B surface antigen (sAg) positive or HBV DNA positive)
• Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA)
• Chronic liver disease
• Chronic kidney disease
• Active and poorly controlled atherosclerotic cardiovascular disease
• QTc interval \>450msec (male) or \>470msec (female)

Sponsors & Collaborators

• Michael Peluso, MD: lead
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94044, United States

Location

MeSH Terms

Interventions

ALT-803

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)