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IL-15 Superagonist + Antibodies for HIV/AIDS
Study Summary
This trial is testing a new drug, N-803, to see if it can help control HIV-1 without the need for antiretroviral therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a history of heart disease.I am infected with HIV-1.I am currently on HIV treatment that is not NRTI or integrase inhibitor.I have been on an ART regimen with specific drugs for at least 6 weeks.I have been on antiretroviral therapy for at least 96 weeks.I agree to use two forms of birth control if there's a chance I could get pregnant.My weight is between 50 kg and 115 kg.My HIV viral load has been under 50 copies/mL for the last 96 weeks.I started HIV treatment soon after my diagnosis.I haven't taken any immune system modifying drugs in the last 6 months.I have never received an HIV vaccine or monoclonal antibody therapy.I agree to use barrier methods for contraception during the study.I have had cognitive issues due to HIV.I have had cancer linked to HIV.I have completed a leukapheresis procedure before joining.My HIV treatment has failed for at least two drug classes.I have taken a pregnancy test in the last 30 days and it was negative.I have received immunoglobulin therapy before.My lab results meet specific criteria for a study on my condition.I have had an AIDS-defining illness, except for recurrent pneumonia.I have a serious ongoing health issue.
- Group 1: Arm A: N-803 only
- Group 2: Arm B: N-803 in combination with 10-1074 and VRC07-523LS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Have any other studies investigated the potential of N-803 (IL-15 Superagonist)?
"N-803 (IL-15 Superagonist) was first researched in 2014 at Arkansas Urology. Presently, there are 17 completed trials on record and 20 that are actively seeking participants; many of these studies take place out of Chicago, Illinois."
Does this study represent a pioneering effort in its field?
"N-803 (IL-15 Superagonist) trials have been conducted in 332 cities across a single country since ImmunityBio, Inc. sponsored the first phase 1 & 2 study of 596 participants which was completed back in 2014. Presently, 20 active studies for this agent are underway."
Has the FDA accepted N-803 (IL-15 Superagonist) as a viable therapeutic treatment?
"The safety profile of N-803 (IL-15 Superagonist) is assessed as a 1 since it has only undergone Phase I trials, indicating that there is limited clinical evidence to support its efficacy and security."
How many people are actively participating in this research endeavor?
"Affirmative. According to clinicaltrials.gov, the posting of this trial was published on May 21st 2021 and has been recently modified on September 22nd 2022. 46 individuals need to be enrolled at 12 various medical sites."
Are there any recruitment opportunities for volunteers in this experiment?
"Clinicaltrials.gov has indicated that this medical study is actively seeking to add more patients, with the first post dated May 21st 2021 and most recent update on September 22nd 2022."
In how many disparate locations is this experiment being conducted?
"Currently, this clinical investigation is being conducted in 12 cities across the United States. These include Chicago, Los Angeles and Boston amongst other locales. To make participation as convenient as possible for participants, it's best to choose a nearby site."
Is the enrollment process open to individuals aged 35 or over?
"This study allows any patient aged 18-65 to be enrolled, as indicated by the parameters of the inclusion criteria."
Could I participate in this clinical trial?
"This clinical trial is seeking 46 participants aged 18-65 with HIV. Furthermore, to be eligible for this study potential patients must have been on an antiretroviral therapy regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least six weeks before randomization, exhibit a QTcF interval of 440 msec within the past 90 days prior to enrollment into the program, and had their ART treatment prescribed 96 weeks ahead of being randomized."
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