N-803 for HIV Infections

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Minnesota, Minneapolis, MN
HIV Infections+3 More
N-803 - Biological
Eligibility
18+
All Sexes
Eligible conditions
HIV Infections

Study Summary

This study is evaluating whether a drug which reactivates HIV may help reduce the amount of HIV in the body.

See full description

Eligible Conditions

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Hiv
  • AIDS

Treatment Effectiveness

Study Objectives

This trial is evaluating whether N-803 will improve 1 primary outcome and 1 secondary outcome in patients with HIV Infections. Measurement will happen over the course of 6 months.

6 months
Frequency of CD8+ T cells in follicles
Safety (adverse event rate)

Trial Safety

Trial Design

2 Treatment Groups

Control
N-803

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. N-803 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

N-803
Biological
All participants will receive the intervention, N-803 treatment.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

University of Minnesota - Minneapolis, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
On continuous antiretroviral therapy for over 24 months without any interruptions of greater than 14 consecutive days, without plans to modify ARTduring the study period.
Screening plasma HIV RNA levels < 20 copies/mL and on at least 1 determination in past 12 months (isolated single values greater than or equal to 20 but < 200 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations)
Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before screen. Inhaled, nasal spray, and topical steroids are acceptable.
Acceptable blood pressure and heart rate parameters within normal limits (systolic = 88-140mmHg; diastolic = 50-<90mmHg; heart rate = 46-100 bpm). Treatment with antihypertensive medication is allowed. However, if someone is on a beta-blocker this must be switched to another class of medication as there is a theoretical risk for bradycardia if the participant were to experience cytokine release syndrome symptoms (which has not happened with this drug delivered SQ).
Intrauterine device (IUD) with published data showing that expected failure rate is < 1% per year
HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load.
Screening CD4+ T cell count greater than or equal to 350 cells/mm3 and nadir CD4+ T cell count of >200 per participant report.
Condoms (male or female) with or without a spermicidal agent
Diaphragm or cervical cap with spermicide
Tubal ligation

Patient Q&A Section

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

What are the signs of hiv infections?

Add answer

Most HIV-positive men are not affected by any of the symptoms of AIDS. A small percentage of AIDS patients may develop fever, night sweats and weight loss.

Unverified Answer

How many people get hiv infections a year in the United States?

Add answer

The rate of new diagnoses among Americans varies, although a significant proportion of Americans have at least one infection. The number of new HIV infections per year ranged from 24,800 in San Francisco in 2012 to 31,700 in Miami in 2013. A few states, including Connecticut, Florida, Michigan, New York, and New Jersey, had the highest numbers of new HIV infections per year.

Unverified Answer

Can hiv infections be cured?

Add answer

HIV is a chronic and progressive illness which cannot be cured. However, an effective combination antiretroviral regimen can reduce the incidence and severity of many of the acute and persistent symptoms of HIV infection such as fever and anemia, while minimizing the development of drug resistance.

Unverified Answer

What causes hiv infections?

Add answer

A total of 30% of the adults in West Midlands had a personal history of a recent HIV infection. However it was not known what caused the infection. Some people thought it could be a result of having unsafe sex or an injection device. Others reported injecting needles and sharing clothing without washing thoroughly. Those who had an HIV infection thought that it was due to contracting it via blood transfusions. A full knowledge of HIV risk factors should be disseminated with accurate messages about prevention.

Unverified Answer

What is hiv infections?

Add answer

HIV infections is a chronic disease that usually takes many years to develop. The disease is often asymptomatic and many of those who are already diagnosed with the disease are unaware of their status. Symptoms may differ depending on the type of HIV infection. These symptoms include: fevers, weight loss, muscle pains and bleeding. HIV infections can also be transmitted through sexual activity, blood transfusion, shared drug needles or syringes during injection practices.

Unverified Answer

What are common treatments for hiv infections?

Add answer

In this sample of women with hiv infections, few women wanted to remain uninfected, but most were treatment-seeking. A substantial percentage opted to not pursue treatment or engage in self-help instead.

Unverified Answer

Have there been any new discoveries for treating hiv infections?

Add answer

There are ongoing research goals for the treatment of hiv/AIDS. The discovery of other new drugs that can target viral molecules could lead to a possible cure for hiv.

Unverified Answer

Is n-803 safe for people?

Add answer

Data from a recent study of this study suggest that n-803 is generally well tolerated in subjects with advanced HIV, and with the potential for increased CD4+ T-cell counts, although safety has yet to be demonstrated.

Unverified Answer

Does n-803 improve quality of life for those with hiv infections?

Add answer

In a recent study, findings supports the use of n-803 as a first-line treatment for HIV infection and the potential to help improve the quality of life.

Unverified Answer

How does n-803 work?

Add answer

In our study, the addition of n-803 to the HIV treatment did not change the immunologic response. Thus, even with the addition of n-803 to the antiretroviral therapy, CD4(+) T cells were not able to achieve sufficient levels to clear the infections. Nevertheless, the antiviral effects of n-803 were also not reversed by the treatment itself when compared to the non-infected control. The authors concluded that there is no evidence for the effects of n-803 in patients with HIV-1 infection who have already achieved high levels of viremia in the blood.

Unverified Answer

Has n-803 proven to be more effective than a placebo?

Add answer

N808 was more effective than a placebo for patients with or without CD4 cell counts > or = 200 cells/mm; the efficacy of N808 in patients with CD4 cells>200/xl decreases significantly if the treatment is started earlier than two weeks after ART. N808 can be considered as a possible option in patients with severe immunodeficiencies.

Unverified Answer

How serious can hiv infections be?

Add answer

Serious infections include mycobacterial disease, pneumococcal disease, and influenza disease. Of all the reported infections, those with an identifiable etiology and those requiring hospitalization are the most serious.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for HIV Infections by sharing your contact details with the study coordinator.