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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

NCT04340596 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-03-25

No results posted yet for this study

Summary

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).

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

N-803 (IL-15 Superagonist)

Administered by subcutaneous (SQ) injection

BIOLOGICAL

VRC07-523LS

Administered by intravenous (IV) infusion

BIOLOGICAL

10-1074

Administered by intravenous (IV) infusion

Sponsors & Collaborators

  • Rockefeller University

    collaborator OTHER

  • ImmunityBio, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Timothy Wilkin, MD, MPH · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2026-06-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04340596 on ClinicalTrials.gov