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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

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
National Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·ClinicalTrials.gov·biologicalRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
HIV Infection
Drug/Device/Intervention
N-803 (IL-15 Superagonist)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Location
Los Angeles,San Diego,San Francisco,Washington,Chicago,Boston,Saint Louis,New York,Chapel Hill,Cleveland,Philadelphia, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 21, 2021
End date
Nov 30, 2024
Enrollment
46 participants
Primary outcome

Occurrence of a Grade ≥3 adverse event (AE) that is at least possibly related to N-803, as judged by the Clinical Management Committee (CMC),Number of N-803 doses completed,Proportion of participants requiring dose reduction,Proportion of participants with plasma HIV-1 RNA 200 copies/mL 8 weeks after interruption of ART

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).

ICD-10 classifications
HIV disease resulting in other viral infectionsHuman immunodeficiency virus [HIV] diseaseHIV disease resulting in other bacterial infectionsAcute HIV infection syndromeUnspecified human immunodeficiency virus [HIV] disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04340596
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04340596 through Pure Global AI's free database. This Phase 1 trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID) and is currently Recruiting. The study focuses on HIV Infection. Target enrollment is 46 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.