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Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease

NCT04808908 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-02

Study results available
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Summary

N-803 has demonstrated ability to reactivate HIV from latency and can activate T cells and NK cells to clear those cells, thus reducing the reservoir. However, a concern is that CD8 T cells may be excluded from the B cell follicles, where a significant part of the reservoir resides. Webb, et al, has shown that in SIV infected monkeys CD8 T cells in follicles increase in frequency when N-803 is administered. We hypothesize that in HIV infected humans treated with N-803 that CD8 T cells will increase in B cell follicles and that there will be a further reduction in the frequency of cells with an inducible provirus.

Conditions

  • Hiv
  • HIV Infections
  • AIDS

Interventions

BIOLOGICAL

N-803

N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Timothy Schacker, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-07-18
Completion
2023-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04808908 on ClinicalTrials.gov