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

HIV Infections Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

A phase 1B single arm study of 10 HIV-infected adults on effective ART will be performed. This is a two-center, non-randomized, open label, and uncontrolled study.

All participants will undergo an extensive baseline evaluation 7-14 days before the first dose that will include an excisional biopsy of a lymph node, colonic biopsies, and leukapheresis. Participants will then receive three doses of N-803 administered every 21 days. A second excisional biopsy will be performed between 7-14 days after the final dose. The study drug N-803 will be administered at 6 mcg/kg, which is the maximum tolerated dose determined in a recently completed dose-escalation study. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS
• Hiv
• HIV Infections

• NCT number: NCT04808908
• Study type: Interventional
• Source: University of Minnesota
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2021
• Completion date: January 1, 2023