Open Actively Recruiting

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

About

Brief 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
65 Years

Inclusion Criteria

  • HIV-1 infection
  • On ART for at least 96 weeks prior to randomization
  • On ART regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization.
  • CD4 cell count >450 cells/mm^3 within 90 days prior to randomization
  • CD4 cell count nadir ≥200 cells/mm^3.
  • Plasma HIV-1 RNA levels of <50 copies/mL for at least 96 weeks prior to randomization
  • Select laboratory results within 90 days of randomization
  • IC90 to 10-1074 of ≤1.5 mcg/mL, 10-1074 maximum percent inhibition (MPI) ≥98%, and IC80 to VRC07-523LS of ≤1 mcg/mL on the Monogram PhenoSense assay.
  • QTcF interval ≤440 msec within 90 days prior to randomization.
  • For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 30 days prior to randomization
  • Cisgender women and transgender men of reproductive potential must agree to use two methods of contraception, if participating in sexual activity that could lead to pregnancy.
  • Cisgender men and transgender women participants engaging in sexual activity that could lead to pregnancy and who are of reproductive potential must agree to use a barrier method of contraception
  • Willingness to abstain from sexual intercourse or use a barrier method of contraception consistently
  • Willingness to participate in an ATI.
  • Weight >50 kg and <115 kg.
  • Completion of pre-entry leukapheresis

Exclusion Criteria

  • History of AIDS-defining illness, with the exception of recurrent pneumonia.
  • History of or current clinical cardiovascular disease
  • Current clinically significant acute or chronic medical condition
  • History of HIV-associated neurocognitive disease
  • History of an HIV-associated malignancy
  • ART initiated during acute HIV infection
  • Current receipt of ART other than NRTI and integrase inhibitor.
  • Resistance to one or more drugs in two or more ARV drug classes.
  • Receipt of any therapeutic HIV vaccine or monoclonal antibody therapy (anti-HIV or otherwise) at any time in the past.
  • History of prior immunoglobulin (IgG) therapy.
  • History of use of any immunomodulatory medications within 6 months prior to randomization
  • Participation in another clinical study of an investigational product currently or within past 12 weeks
  • Breastfeeding or pregnancy

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
21-000814
Category
Infectious Disease
Contact
Irma Franco-Gonzalez
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04340596
For detailed technical eligibility, visit ClinicalTrials.gov.