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 - Trial NCT04340596
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.
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Study Focus
Sponsor & Location
National Institute of Allergy and Infectious Diseases (NIAID)
Timeline & Enrollment
Phase 1
May 21, 2021
Nov 30, 2024
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
Data Source
ClinicalTrials.gov
NCT04340596
Non-Device Trial