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Cytokine

N-803 for Human Immunodeficiency Virus Infection

Phase 1
Waitlist Available
Led By Timothy Schacker, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing a drug, N-803, to see if it can help reduce the HIV reservoir (the amount of HIV in the body that is inactive). The drug has shown promise in reactivating HIV from latency and activating T cells and NK cells to clear those cells. However, a concern is that CD8 T cells may be excluded from the B cell follicles, where a significant part of the reservoir resides.

Eligible Conditions
  • Human Immunodeficiency Virus (HIV) Infection
  • HIV (Human Immunodeficiency Virus)
  • Acquired Immunodeficiency Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety (Adverse Event Rate)
Secondary outcome measures
Frequency of CD8+ T Cells in Follicles

Side effects data

From 2022 Phase 2 trial • 20 Patients • NCT02989844
100%
Platelet count decreased
100%
White blood cell decreased
100%
Injection site reaction
100%
Neutrophil count decreased
100%
Anemia
100%
Hypertension
85%
Chills
75%
Hyperglycemia
75%
Dyspnea
60%
Fatigue
50%
Aspartate aminotransferase increased
50%
Rash maculo-papular
45%
Headache
40%
Fever
40%
Edema limbs
40%
Skin and subcutaneous tissue disorders - Other, specify
40%
Creatinine increased
35%
Nausea
35%
Upper respiratory infection
30%
Hypocalcemia
30%
Hypotension
25%
Lymphocyte count decreased
25%
Hyponatremia
25%
Alanine aminotransferase increased
25%
Diarrhea
20%
Cough
20%
Vomiting
20%
Acute kidney injury
20%
Fall
20%
Hypermagnesemia
20%
Hypoalbuminemia
20%
Gait disturbance
15%
Dizziness
15%
Infections and infestations - Other, specify
15%
Paronychia
10%
Abdominal pain
10%
Insomnia
10%
General disorders and administration site conditions - Other, specify
10%
Dry eye
10%
Weight loss
10%
Atrial Fibrillation
10%
Alkaline phosphatase increased
10%
Dry mouth
10%
Hypomagnesemia
5%
Breast pain
5%
Vasovagal reaction
5%
Productive cough
5%
Pneumonitis
5%
Flu like symptoms
5%
Anorexia
5%
Lung infection
5%
Pericardial effusion
5%
Skin infection
5%
Peripheral sensory neuropathy
5%
Rash acneiform
5%
Pain in extremity
5%
Stomach pain
5%
Allergic reaction
5%
Erectile dysfunction
5%
Neck pain
5%
Sepsis
5%
Dysphagia
5%
Blood bilirubin increased
5%
Myalgia
5%
Blurred Vision
5%
Generalized muscle weakness
5%
Back pain
5%
Infections and infestations - Other,
5%
Immune system disorders - Other,
5%
Respiratory failure
5%
Ear pain
5%
Atrial fibrillation
5%
Pain
5%
Gastroesophageal reflux disease
5%
Gastrointestinal disorders - Other, specify
5%
Vulval infection
5%
Musculoskeletal and connective tissue disorder - Other, specify
5%
Bronchial obstruction
5%
Pleural effusion
5%
Wheezing
5%
Nasal congestion
5%
Dry skin
5%
Mucositis oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-803

Trial Design

1Treatment groups
Experimental Treatment
Group I: N-803Experimental Treatment1 Intervention
All participants will receive the intervention, N-803 treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,481,122 Total Patients Enrolled
University of MinnesotaLead Sponsor
1,377 Previous Clinical Trials
1,588,286 Total Patients Enrolled
Timothy Schacker, MDPrincipal InvestigatorUniversity of Minnesota
7 Previous Clinical Trials
99 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor present a unique opportunity?

"At present, 20 clinical trials for N-803 are being conducted across 332 cities in 1 country. The inaugural study of this drug was run by ImmunityBio, Inc., and involved 596 patients from 2014 to 2019 during its Phase 1&2 pre-approval process. Since then 8 more studies have been completed."

Answered by AI

Is this investigation accepting applicants who are more senior in age?

"This particular trial requires participants to be between 18 and 65 years of age. However, there are a total of 130 clinical trials for those under the legal limit and 435 for individuals who exceed this upper boundary."

Answered by AI

Is there a documented history of experimentation with N-803?

"Currently, there are 20 open trials studying the effects of N-803 with 3 studies in Phase 3. While Ann Arbor is a hotbed for research on this substance, it can be found at over 500 sites around the world."

Answered by AI

Has N-803 been sanctioned by the U.S. Food and Drug Administration?

"Scoring a 1, there is limited evidence of N-803's safety and efficacy as this is an early stage clinical trial."

Answered by AI

Are there any open slots available for this research trial?

"Unfortunately, this research is not currently enrolling patients. The trial was initially advertised on April 1st 2021 and the details were last updated on August 1st 2022. If you are keen to take part in a clinical trial, there are 568 HIV-related studies actively recruiting and 20 for N-803 awaiting volunteers."

Answered by AI

To what extent is this experiment engaging participants?

"This trial has stopped taking on new participants, as the last update to its posting was recorded at August 1st 2022. For those searching for similar opportunities, there are 568 clinical studies looking into HIV infections and 20 studies recruiting patients with N-803."

Answered by AI

Who meets the criteria to become a participant in this medical experiment?

"This study is actively recruiting 23 participants between 18 and 65 years old, diagnosed with HIV. To be considered for the trial, applicants must have been on continuous antiretroviral therapy for two years or longer without any breaks of more than two weeks in addition to being off immunosuppressive drugs such as prednisone for at least 14 days before screening. Condoms are also necessary during participation (with or without spermicide)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease
2021. "Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04808908.
~2 spots leftby Apr 2025
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