Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Bro… (NCT04340596) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption
United States118 participantsStarted 2021-05-21
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of N-803, an IL-15 superagonist, with or without combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* HIV-1 infection
* On ART for at least 96 weeks prior to randomization
* On ART regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization.
* CD4 cell count \>450 cells/mm\^3 within 90 days prior to randomization
* CD4 cell count nadir ≥200 cells/mm\^3.
* Plasma HIV-1 RNA levels of \<50 copies/mL for at least 96 weeks prior to randomization
* Select laboratory results within 90 days of randomization
* IC90 to 10-1074 of ≤1.5 mcg/mL, 10-1074 maximum percent inhibition (MPI) ≥98%, and IC80 to VRC07-523LS of ≤1 mcg/mL on the Monogram PhenoSense assay.
* QTcF interval ≤440 msec within 90 days prior to randomization.
* For cisgender women and transgender men of reproductive potential, negative urine or serum pregnancy test within 30 days prior to randomization
* Cisgender women and transgender men of reproductive potential must agree to use two methods of contraception, if participating in sexual activity that could lead to pregnancy.
* Cisgender men and transgender women participants engaging in sexual activity that could lead to pregnancy and who are of reproductive potential must agree to use a barrier method of contraception
* Willingness to abstain from sexual intercourse or use a barrier method of contraception consistently
* Willingness to participate in an ATI.
* Weight \>50 kg and \<115 kg.
* Completion of pre-entry leukapheresis
Exclusio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of a Grade ≥3 adverse event (AE) that is at least possibly related to N-803, as judged by the Clinical Management Committee (CMC)
Timeframe: Step 2 week 1 to week 52
2
Number of N-803 doses completed
Timeframe: From step 2 week 1 to step 2 week 22
3
Proportion of participants requiring dose reduction
Timeframe: From step 2 week 4 to step 2 week 22
4
Proportion of participants with plasma HIV-1 RNA <200 copies/mL 8 weeks after interruption of ART
Timeframe: At step 3 week 8
Trial details
NCT IDNCT04340596
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)