NCT04340596

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

Active, enrolled Phase 1 Last updated 25 March 2025

What this trial tests

Phase 1 trial testing N-803 (IL-15 Superagonist) in HIV Infection in 118 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 May 2021

Primary endpoint
30 June 2026

30 December 2026

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	118
Start date	21 May 2021
Primary completion	30 June 2026
Estimated completion	30 December 2026
Sites	14 locations across United States

Drugs / interventions tested

• N-803 (IL-15 Superagonist) — full drug profile →
• VRC07-523LS — full drug profile →
• 10-1074

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 65, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Broadly neutralizing monoclonal antibodies for HIV prevention.
   Miner MD, Corey L, Montefiori D. · · 2021 · cited 34× · PMID 34806308 · DOI 10.1002/jia2.25829
2. The application of Interleukin-2 family cytokines in tumor immunotherapy research.
   Zhou Y, Quan G, Liu Y, Shi N, et al · · 2023 · cited 32× · PMID 36936961 · DOI 10.3389/fimmu.2023.1090311
3. Can Broadly Neutralizing HIV-1 Antibodies Help Achieve an ART-Free Remission?
   Hsu DC, Mellors JW, Vasan S. · · 2021 · cited 30× · PMID 34322136 · DOI 10.3389/fimmu.2021.710044
4. Analytical Treatment Interruption in HIV Trials: Statistical and Study Design Considerations.
   Zheng L, Tierney C, Bosch RJ. · · 2021 · cited 22× · PMID 34213731 · DOI 10.1007/s11904-021-00569-8
5. Clinical trials of broadly neutralizing monoclonal antibodies in people living with HIV - a review.
   Mahomed S, Pillay K, Hassan-Moosa R, Galvão BPGV, et al · · 2025 · cited 20× · PMID 40189566 · DOI 10.1186/s12981-025-00734-8
6. The HIV Latency Reversal Agent HODHBt Enhances NK Cell Effector and Memory-Like Functions by Increasing Interleukin-15-Mediated STAT Activation.
   Macedo AB, Levinger C, Nguyen BN, Richard J, et al · · 2022 · cited 20× · PMID 35867565 · DOI 10.1128/jvi.00372-22
7. NK Cells, Monocytes and Macrophages in HIV-1 Control: Impact of Innate Immune Responses.
   Mensching L, Hoelzemer A. · · 2022 · cited 16× · PMID 35711433 · DOI 10.3389/fimmu.2022.883728
8. Correlates of HIV-1 control after combination immunotherapy.
   Peluso MJ, Sandel DA, Deitchman AN, Kim SJ, et al · · 2026 · cited 15× · PMID 41326736 · DOI 10.1038/s41586-025-09929-5