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NCT04808908 · ClinicalTrials.gov registry record · Phase 1
Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04808908: Completed Phase 1 study, sponsored by University of Minnesota.
NCT04808908 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04808908, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
Safety is a primary outcome of this phase 1b trial. Safety will be reported as the number of adverse events per participant. This includes all adverse events (total regardless of severity)
Interventions
- BIOLOGICAL N-803
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2023-01-01 |
| Phase | Phase 1 |
What the finished NCT04808908 record still lists
NCT04808908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which N-803 is the first listed.
NCT04808908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04808908 about?
NCT04808908 is a clinical study titled "Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease". 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...
What is the current status of trial NCT04808908?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-04-01. Estimated completion is 2023-01-01.
What interventions are being tested in trial NCT04808908?
The interventions under investigation include: N-803 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04808908?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04808908's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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