HIV InfectionPhase 1NCT04340596
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
A Phase 1 study testing N-803 (IL-15 Superagonist), VRC07-523LS and 10-1074 in people with HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- N-803 (IL-15 Superagonist), VRC07-523LS and 10-1074
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 14 sitesUnited States
- Study dates
- 21 May 2021to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- History of AIDS-defining illness, with the exception of recurrent pneumonia.
- History of or current clinical cardiovascular disease
- Current clinically significant acute or chronic medical condition
- History of HIV-associated neurocognitive disease
- History of an HIV-associated malignancy
- ART initiated during acute HIV infection
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- Current receipt of ART other than NRTI and integrase inhibitor.
- Resistance to one or more drugs in two or more ARV drug classes.
- Receipt of any therapeutic HIV vaccine or monoclonal antibody therapy (anti-HIV or otherwise) at any time in the past.
- History of prior immunoglobulin (IgG) therapy.
- History of use of any immunomodulatory medications within 6 months prior to randomization
- Participation in another clinical study of an investigational product currently or within past 12 weeks
- Breastfeeding or pregnancy
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Alabama CRS (Site ID# 31788)
Birmingham, Alabama, 35222
Massachusetts General Hospital CRS (MGH CRS) (Site ID: 101)
Boston, Massachusetts, 02114
Chapel Hill CRS (Site ID: 3201)
Chapel Hill, North Carolina, 27599
Northwestern University CRS
Chicago, Illinois, 60611
Case Clinical Research Site
Cleveland, Ohio, 44106
UCLA CARE Center CRS
Los Angeles, California, 90035
Columbia P&S CRS
New York, New York, 10032
Weill Cornell Uptown CRS (Site ID: 7803)
New York, New York, 10065
New Jersey Medical School Clinical Research Center CRS [Site ID: 31786]
Newark, New Jersey, 07103
Penn Therapeutics, CRS (Site ID: 6201)
Philadelphia, Pennsylvania, 19104
UCSD Antiviral Research Center CRS (Site ID: 701)
San Diego, California, 92103
University of California, San Fransisco HIV/AIDS CRS
San Francisco, California, 94110
Washington University Therapeutics (WT) CRS
St Louis, Missouri, 63110-1010
Whitman-Walker Institute, Inc. CRS (Site ID: 31791)
Washington D.C., District of Columbia, 20005
About this study
Official title: A Phase I Clinical Trial of the 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
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).
Read the detailed description
This study will 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).
Participants will be screened for eligibility and undergo leukapheresis, and a subset will also undergo optional rectal biopsy and/or lymph node fine needle aspirations (FNAs) (Step 1).
After pre-entry and determination of eligibility in Step 1, participants will be randomized before Step 2 entry to either the N-803 only arm (Arm A) or the N-803 with combination bNAbs arm (Arm B):
- Arm A will receive a dose of N-803, 6 mcg/kg, subcutaneously 1 week after Step 2 entry and then every 3 weeks for a total of eight doses (during the first 22 weeks).
- Arm B will receive the following (during the first 22 weeks):
- Combination bNAb at Step 2 entry with VRC07-523LS dosed at 20 mg/kg and 10-1074 dosed at 30 mg/kg, intravenously;
- A dose of N-803, 6 mcg/kg, subcutaneously 1 week after Step 2 entry and then every 3 weeks for a total of eight doses;
- A second dose of 10-1074 at week 9 of Step 2 dosed at 30 mg/kg, intravenously
After completing randomized treatment (Step 2), participants will interrupt antiretroviral therapy (ART) (Step 3) and will be followed closely to monitor for indications for reinitiation of ART (Step 4).
After Step 2 entry, most participants will be followed for approximately 100 weeks across the remaining three study steps (i.e., Steps 2, 3, and 4).
Step 1 will last up to 90 days, Step 2 will last approximately 52 weeks (study intervention), Step 3 will last up to 24 weeks (ATI), and Step 4 will last 24 weeks (ART restart).
- Conditions
- HIV Infection
- Being tested
- N-803 (IL-15 Superagonist), VRC07-523LS, 10-1074
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-803 (IL-15 Superagonist)Biological
Administered by subcutaneous (SQ) injection
VRC07-523LSBiological
Administered by intravenous (IV) infusion
10-1074Biological
Administered by intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A: N-803 only | Experimental | Participants will receive N-803 6 mcg/kg 1 week after Step 2 entry and then every 3 weeks for a total of eight doses. Receives: Biological: N-803 (IL-15 Superagonist) |
| Arm B: N-803 in combination with 10-1074 and VRC07-523LS | Experimental | Participants will receive N-803 in combination with 10-1074 and VRC07-523LS as follows:
* At Step 2 entry:
* VRC07-523LS 20 mg/kg
* 10-1074 30 mg/kg
* At Step 2, week 1: N-803 6 mcg/kg every 3 weeks for eight doses
* At Step 2, week 9: 10-1074 30 mg/kg Receives: Biological: N-803 (IL-15 Superagonist); Biological: VRC07-523LS; Biological: 10-1074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Step 2 week 1 to week 52
Number of N-803 doses completed
Eight doses of N-803 are scheduled at the distinct time points listed in Time Frame. At each timepoint, dose completion status is recorded. Number of N-803 doses completed is the total number completed doses across all 8 timepoints.
Measured: From step 2 week 1 to step 2 week 22
Proportion of participants requiring dose reduction
Eight doses of N-803 are scheduled at distinct time points (Step 2 weeks 1, 4, 7, 10, 13, 16, 19 and 22). Proportion of participants requiring dose reduction is calculated as the number of participants who receive a reduced dose of N-803 at any of the 7 scheduled doses occurring after the first dose, divided by the total number of participants receiving N-803.
Measured: From step 2 week 4 to step 2 week 22
Proportion of participants with plasma HIV-1 RNA <200 copies/mL 8 weeks after interruption of ART
Measured: At step 3 week 8
Secondary outcomes (12)
Occurrence of a Grade ≥2 AE without regard to relationship to study treatment
Measured: Study entry to participant's last study visit, at approx. study week 100
Occurrence of a Grade ≥2 AE that is at least possibly related to N-803, as judged by the CMC
Measured: Step 2 week 1 to week 52
Occurrence of a Grade ≥2 AE that is at least possibly related to VRC07-523LS or 10-1074
Measured: Step 2 week 0 to week 52
Cell-associated HIV-1 RNA
Measured: At Step 2 weeks 0, 1, 7, 13, 19, 22, 26 and 32
Measurement of HIV-1 reservoir (dQVOA)
Measured: At Step 2 weeks 0, 1, 7, 13, 19, 22, 26 and 32
Measurement of plasma viremia by HIV-1 single copy assay
Measured: At step 1 pre-entry evaluation and step 2 weeks 0, 1, 7, 13, 22 and 32
Measurement of intact proviral DNA
Measured: At Step 2 weeks 0, 1, 7, 13, 19, 22, 26 and 32
Total HIV-1 DNA
Measured: At Step 2 weeks 0, 1, 7, 13, 19, 22, 26 and 32
Proportion of participants with plasma HIV-1 RNA <200 copies/mL at 4, 12 and 24 weeks after interruption of ART in Step 3
Measured: At step 3 weeks 4, 12, and 24
PK parameters: AUC0-τ of 10-1074
Measured: At step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
PK parameters: AUC0-τ of VRC07-523LS
Measured: At step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
Proportion of participants with antidrug antibodies
Presence of anti-N803, anti-10-1074, and anti-VRC07-523LS antibodies
Measured: At step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start21 May 2021
- Primary completion7 May 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Rockefeller University, ImmunityBio, Inc.
- Responsible party
- Sponsor
- Investigators
- Timothy Wilkin, MD, MPH, Study chair, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340596
- Sponsor's protocol ID
- ACTG A5386
- Other IDs
- 38639
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of the 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
- ClinicalTrials.gov ID
- NCT04340596
- Acronym / sponsor ID
- ACTG A5386
- Conditions
- HIV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Rockefeller University, ImmunityBio, Inc.
- Study start
- 21 May 2021 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study will 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).
Participants will be screened for eligibility and undergo leukapheresis, and a subset will also undergo optional rectal biopsy and/or lymph node fine needle aspirations (FNAs) (Step 1).
After pre-entry and determination of eligibility in Step 1, participants will be randomized before Step 2 entry to either the N-803 only arm (Arm A) or the N-803 with combination bNAbs arm (Arm B):
- Arm A will receive a dose of N-803, 6 mcg/kg, subcutaneously 1 week after Step 2 entry and then every 3 weeks for a total of eight doses (during the first 22 weeks).
- Arm B will receive the following (during the first 22 weeks):
- Combination bNAb at Step 2 entry with VRC07-523LS dosed at 20 mg/kg and 10-1074 dosed at 30 mg/kg, intravenously;
- A dose of N-803, 6 mcg/kg, subcutaneously 1 week after Step 2 entry and then every 3 weeks for a total of eight doses;
- A second dose of 10-1074 at week 9 of Step 2 dosed at 30 mg/kg, intravenously
After completing randomized treatment (Step 2), participants will interrupt antiretroviral therapy (ART) (Step 3) and will be followed closely to monitor for indications for reinitiation of ART (Step 4).
After Step 2 entry, most participants will be followed for approximately 100 weeks across the remaining three study steps (i.e., Steps 2, 3, and 4).
Step 1 will last up to 90 days, Step 2 will last approximately 52 weeks (study intervention), Step 3 will last up to 24 weeks (ATI), and Step 4 will last 24 weeks (ART restart).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: N-803 only | Experimental | Biological: N-803 (IL-15 Superagonist)Participants will receive N-803 6 mcg/kg 1 week after Step 2 entry and then every 3 weeks for a total of eight doses. |
| Arm B: N-803 in combination with 10-1074 and VRC07-523LS | Experimental | Biological: N-803 (IL-15 Superagonist), Biological: VRC07-523LS, Biological: 10-1074Participants will receive N-803 in combination with 10-1074 and VRC07-523LS as follows: * At Step 2 entry: * VRC07-523LS 20 mg/kg * 10-1074 30 mg/kg * At Step 2, week 1: N-803 6 mcg/kg every 3 weeks for eight doses * At Step 2, week 9: 10-1074 30 mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (13 listed)
- History of AIDS-defining illness, with the exception of recurrent pneumonia.
- History of or current clinical cardiovascular disease
- Current clinically significant acute or chronic medical condition
- History of HIV-associated neurocognitive disease
- History of an HIV-associated malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-803 (IL-15 Superagonist)Administered by subcutaneous (SQ) injection | Biological | Arm A: N-803 only, Arm B: N-803 in combination with 10-1074 and VRC07-523LS |
| VRC07-523LSAdministered by intravenous (IV) infusion | Biological | Arm B: N-803 in combination with 10-1074 and VRC07-523LS |
| 10-1074Administered by intravenous (IV) infusion | Biological | Arm B: N-803 in combination with 10-1074 and VRC07-523LS |
Primary outcome
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)
Time frame: Step 2 week 1 to week 52
Number of N-803 doses completed
Time frame: From step 2 week 1 to step 2 week 22
Eight doses of N-803 are scheduled at the distinct time points listed in Time Frame. At each timepoint, dose completion status is recorded. Number of N-803 doses completed is the total number completed doses across all 8 timepoints.
Proportion of participants requiring dose reduction
Time frame: From step 2 week 4 to step 2 week 22
Eight doses of N-803 are scheduled at distinct time points (Step 2 weeks 1, 4, 7, 10, 13, 16, 19 and 22). Proportion of participants requiring dose reduction is calculated as the number of participants who receive a reduced dose of N-803 at any of the 7 scheduled doses occurring after the first dose, divided by the total number of participants receiving N-803.
Proportion of participants with plasma HIV-1 RNA <200 copies/mL 8 weeks after interruption of ART
Time frame: At step 3 week 8
12 secondary outcomes
Occurrence of a Grade ≥2 AE without regard to relationship to study treatment
Time frame: Study entry to participant's last study visit, at approx. study week 100
Occurrence of a Grade ≥2 AE that is at least possibly related to N-803, as judged by the CMC
Time frame: Step 2 week 1 to week 52
Occurrence of a Grade ≥2 AE that is at least possibly related to VRC07-523LS or 10-1074
Time frame: Step 2 week 0 to week 52
Cell-associated HIV-1 RNA
Time frame: At Step 2 weeks 0, 1, 7, 13, 19, 22, 26 and 32
Measurement of HIV-1 reservoir (dQVOA)
Time frame: At Step 2 weeks 0, 1, 7, 13, 19, 22, 26 and 32
Measurement of plasma viremia by HIV-1 single copy assay
Time frame: At step 1 pre-entry evaluation and step 2 weeks 0, 1, 7, 13, 22 and 32
Measurement of intact proviral DNA
Time frame: At Step 2 weeks 0, 1, 7, 13, 19, 22, 26 and 32
Total HIV-1 DNA
Time frame: At Step 2 weeks 0, 1, 7, 13, 19, 22, 26 and 32
Proportion of participants with plasma HIV-1 RNA <200 copies/mL at 4, 12 and 24 weeks after interruption of ART in Step 3
Time frame: At step 3 weeks 4, 12, and 24
PK parameters: AUC0-τ of 10-1074
Time frame: At step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
PK parameters: AUC0-τ of VRC07-523LS
Time frame: At step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
Proportion of participants with antidrug antibodies
Time frame: At step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Wilkin, MD, MPH study chair
Weill Medical College of Cornell University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N-803 (IL-15 Superagonist), VRC07-523LS and 10-1074 in people with HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Step 2 week 1 to week 52). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.