HIVPhase 1ALT-803NCT02191098
Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People
A Phase 1 study testing ALT-803 in people with HIV and Stable ART, run by University of Minnesota at 1 site in United States.
Trial summary
To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of ALT-803 in HIV Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV, Stable ART
- What is being tested?
- ALT-803
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 9 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected adults aged 18 years or over.
- Stable ART for at least 36 months
- Screening plasma HIV RNA levels below level of quantification (<40 to <50 copies RNA/mL depending on the assay) ≥ 2 years (a single measurement above the level of detection but < 100-200 copies/ml will be allowed)
- Screening CD4 count ≥500 cells/mm3
- Laboratory tests performed within 14 days of study enrollment:
- WBC ≥ 3000/mm3
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- Platelets ≥ 50,000/mm3 [Patients may be transfused to meet this requirement]
- Hemoglobin ≥ 8 g/dL (>80g/L) [Patients may be transfused to meet this requirement]
- Calculated glomerular filtration rate (GFR) >45 mL/min/1.73m2
- Total bilirubin ≤ 2.0 X upper limit of institutional normal (ULN)
- AST, ALT, ALP ≤ 2.0 X ULN
- Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFTs > 50% of predicted if symptomatic or prior known impairment.
- Ability to be off prednisone and other immunosuppressive drugs for at least 14 days before first dose of study drug
- Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
- Voluntary written consent
Who cannot join
- Active infection other than HIV currently requiring systemic antimicrobial therapy
- Previously treated on this study or received previous ALT-803
- Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy
- Active fungal infection requiring systemic antifungal therapy
- Active or recurrent herpes or varicella-zoster virus infection requiring treatment (or chronic suppression)
- Chronic hepatitis B or C
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- Planning or current pregnancy or breastfeeding
- Intended modification of antiretroviral therapy in the next 24 weeks
- NYHA (New York Heart Association) Class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction
- Symptomatic congestive heart failure, unstable angina pectoris, or Myocardial infarction within 6 months prior to screening
- Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
- History or evidence of uncontrollable CNS disease
- Prior organ allograft or allogeneic transplantation
- On-going chronic systemic or regular inhaled corticosteroid use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible)
- Psychiatric illness/social situations that would limit compliance with study requirements
- Other illness that in the opinion of the investigator would exclude the patient from participating in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People on Optimized ART With Undetectable Plasma HIV RNA
To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of ALT-803 in HIV
Read the detailed description
This is an open-label, single-arm intra-patient dose escalating pilot study of ALT-803, a recombinant human super agonist interleukin-15 (IL-15) complex with an expansion cohort at the maximum tolerated dose (MTD). The primary aim is to investigate the safety and tolerability of ALT-803 in HIV-infected people receiving potent and optimized antiretroviral therapy. All infusions will occur on a Monday. Subjects will be monitored for 24 hours after the first infusion and then for 6 hours after each subsequent infusion, provided no unacceptable toxicity.
- Conditions
- HIV, Stable ART
- Being tested
- ALT-803
- Keywords
- HIV, ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT-803Drug
Interleukin 15 (IL-15) is a common γ-chain cytokine that is related to interleukin-2 (IL-2) and is a critical factor for the development, proliferation, and activation of effector natural killer (NK) and CD8+ memory T cells
| Study group | Role | What they receive |
|---|---|---|
| ALT-803 | Experimental | ALT-803 Receives: Drug: ALT-803 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of ALT-803 in HIV-infected subjects
Safety and tolerability is determined by the incidence of adverse events, size of the inducible reservoir as estimated using the TILDA assay
Measured: 4 weeks
Secondary outcomes (1)
Assess the impact of ALT-803 on the size of the inducible reservoir,
Assess the impact of ALT-803 on the size of the inducible reservoir, as estimated using the TILDA assay, in total CD4+ T cells and memory subsets
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2015
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Schacker, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191098
- Sponsor's protocol ID
- 1508M77601-1
- Acronym
- ALT-803
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2014
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miller JS, Davis ZB, Helgeson E, Reilly C, Thorkelson A, Anderson J, Lima NS, Jorstad S, Hart GT, Lee JH, Safrit JT, Wong H, Cooley S, Gharu L, Chung H, Soon-Shiong P, Dobrowolski C, Fletcher CV, Karn J, Douek DC, Schacker TW. Safety and virologic impact of the IL-15 superagonist N-803 in people living with HIV: a phase 1 trial. Nat Med. 2022 Feb;28(2):392-400. doi: 10.1038/s41591-021-01651-9. Epub 2022 Jan 31.
PubMed 35102335
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Principle Study of Pulse Dosing of IL-15 to Deplete the Reservoir in HIV Infected People on Optimized ART With Undetectable Plasma HIV RNA
- ClinicalTrials.gov ID
- NCT02191098
- Acronym / sponsor ID
- ALT-803 / 1508M77601-1
- Conditions
- HIV, Stable ART
- Keywords
- HIV, ART
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 16 Jul 2014 (estimated)
- 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.
To assess the safety and tolerability of ALT-803, as well as, the potential efficacy of ALT-803 in HIV
Detailed description
This is an open-label, single-arm intra-patient dose escalating pilot study of ALT-803, a recombinant human super agonist interleukin-15 (IL-15) complex with an expansion cohort at the maximum tolerated dose (MTD). The primary aim is to investigate the safety and tolerability of ALT-803 in HIV-infected people receiving potent and optimized antiretroviral therapy. All infusions will occur on a Monday. Subjects will be monitored for 24 hours after the first infusion and then for 6 hours after each subsequent infusion, provided no unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALT-803 | Experimental | Drug: ALT-803ALT-803 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- HIV-1 infected adults aged 18 years or over.
- Stable ART for at least 36 months
- Screening plasma HIV RNA levels below level of quantification (<40 to <50 copies RNA/mL depending on the assay) ≥ 2 years (a single measurement above the level of detection but < 100-200 copies/ml will be allowed)
- Screening CD4 count ≥500 cells/mm3
- Laboratory tests performed within 14 days of study enrollment:
Key exclusion criteria (16 listed)
- Active infection other than HIV currently requiring systemic antimicrobial therapy
- Previously treated on this study or received previous ALT-803
- Latent TB infection or active TB disease prior to completing a standard regimen of anti-TB therapy
- Active fungal infection requiring systemic antifungal therapy
- Active or recurrent herpes or varicella-zoster virus infection requiring treatment (or chronic suppression)
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 |
|---|---|---|
| ALT-803Interleukin 15 (IL-15) is a common γ-chain cytokine that is related to interleukin-2 (IL-2) and is a critical factor for the development, proliferation, and activation of effector natural killer (NK) and CD8+ memory T cells | Drug | ALT-803 |
Primary outcome
Assess the safety and tolerability of ALT-803 in HIV-infected subjects
Time frame: 4 weeks
Safety and tolerability is determined by the incidence of adverse events, size of the inducible reservoir as estimated using the TILDA assay
1 secondary outcome
Assess the impact of ALT-803 on the size of the inducible reservoir,
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 35102335Miller JS, Davis ZB, Helgeson E, Reilly C, Thorkelson A, Anderson J, Lima NS, Jorstad S, Hart GT, Lee JH, Safrit JT, Wong H, Cooley S, Gharu L, Chung H, Soon-Shiong P, Dobrowolski C, Fletcher CV, Karn J, Douek DC, Schacker TW. Safety and virologic impact of the IL-15 superagonist N-803 in people living with HIV: a phase 1 trial. Nat Med. 2022 Feb;28(2):392-400. doi: 10.1038/s41591-021-01651-9. Epub 2022 Jan 31.
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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.
Tim Schacker, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALT-803 in people with HIV and Stable ART, run by University of Minnesota at 1 site 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 15 inclusion and 16 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: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the safety and tolerability of ALT-803 in HIV-infected subjects (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02191098, which also lists 1 linked publication.
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 24 Sep 2026.