HIVPhase 2INTERRUPT-HIVNCT07145164
Interleukin-15 to Promote Post-ART Control of HIV
A Phase 2 study testing N-803 in people with HIV, run by Michael Peluso, MD at 1 site in United States.
Trial summary
Even though HIV medicine stops the virus from making more copies of itself, the virus remains in the body by hiding inside of immune cells. This hidden virus is referred to as the "latent reservoir." Researchers on this team are studying whether stimulating the immune system can change the nature of the latent… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV
- What is being tested?
- N-803
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to Dec 2028
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 70 years at the time of screening
- Documented HIV-1 infection
- On continuous ART for at least 6 months without any interruptions of greater than 14 consecutive days within the preceding 6 months
- Plasma HIV RNA levels less than 200 copies/mL at each determination in the previous 6 months
- Screening CD4+ T-cell count ≥ 350 cells/mm3
- Willingness to interrupt ART as part of the study transient treatment interruption
Who cannot join
- On an ART regimen that includes a non-nucleoside reverse transcriptase inhibitor, unable to switch to a different regimen
- Receipt of any long-acting ART medication (e.g., injectable cabotegravir/rilpivirine, lenacapavir) in the two years preceding screening.
- Known resistance to two or more classes of ART drugs and/or the inability to construct another fully suppressive regimen
- Evidence of HIV "elite" control immediately prior to ART initiation
- Screening platelets < 125,000/mm3
- Screening hemoglobin < 12.5 g/dL for men and <11.5 for women
Show all 17Show fewer
- History of an AIDS-defining illness according to CDC criteria
- History of HIV-associated malignancy
- Non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the 36 months preceding screening, or for whom such therapies are expected in the subsequent 12 months.
- Active Hepatitis B (Hep B) infection (defined as Hep B surface antigen (sAg) positive or HBV DNA positive)
- Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA)
- Chronic liver disease
- Chronic kidney disease
- Active and poorly controlled atherosclerotic cardiovascular disease
- QTc interval >450msec (male) or >470msec (female)
- Pregnant, breastfeeding, or unwilling to use contraception to prevent pregnancy during participation in the study and until 6 months resumption of ART
- Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) in the partner, with sexual partners not known to have HIV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Even though HIV medicine stops the virus from making more copies of itself, the virus remains in the body by hiding inside of immune cells. This hidden virus is referred to as the "latent reservoir." Researchers on this team are studying whether stimulating the immune system can change the nature of the latent reservoir and if this could help people control HIV without the need to take regular HIV medicine.
This study is testing a drug called N-803. N-803 is also known as Interleukin-15 or "IL-15", a powerful and long lasting protein that can affect the immune system by stimulating immune cells such as CD8+ T cells and natural killer (NK) cells. CD8+ T cells and NK cells are both crucial for eliminating infected cells. The drug is FDA-approved for the treatment of bladder cancer, but in this study the drug is being used experimentally for HIV.
- Conditions
- HIV
- Being tested
- N-803, Saline placebo
- Keywords
- HIV, IL-15, N-803, Anktiva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-803Drug
This is the active drug.
Saline placeboDrug
This is the placebo.
| Study group | Role | What they receive |
|---|---|---|
| N-803 | Experimental | Participants in this arm will receive the active study drug during the blinded portion (Phase A) of the trial. They will receive the active study drug during the open-label portion (Phase B) of the trial. Receives: Drug: N-803 |
| Placebo | Placebo comparator | Participants in this arm will receive placebo during the blinded portion (Phase A) of the trial. They will receive the active study drug during the open-label portion (Phase B) of the trial. Receives: Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Solicited Adverse Events
Frequency and grade of each solicited systemic reactogenicity AE (malaise, participant-measured body temperature, fatigue, headache, chills, nausea, muscle aches/pain, joint pain).
Measured: Within 7 days after dosing.
Safety - Unsolicited Adverse Events
Frequency and grade of unsolicited AEs.
Measured: Within 7 days after dosing.
Secondary outcomes (1)
Time to Rebound
Difference in time-to-viral rebound, defined as the first of two consecutive viral loads > the limit of quantification of the assay, between those who previously received the intervention and those who previously received placebo.
Measured: 52 weeks after treatment interruption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start19 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Peluso, MD
- Sponsor type
- University, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research
- Responsible party
- Sponsor-investigator, Michael Peluso, MD, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145164
- Sponsor's protocol ID
- 25-44404
- Acronym
- INTERRUPT-HIV
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data set with longitudinal clinical data will be shared upon the publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-15 to Promote Post-ART Control of HIV
- ClinicalTrials.gov ID
- NCT07145164
- Acronym / sponsor ID
- INTERRUPT-HIV / 25-44404
- Conditions
- HIV
- Keywords
- HIV, IL-15, N-803, Anktiva
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Michael Peluso, MDUniversity, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Aug 2025 (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.
Even though HIV medicine stops the virus from making more copies of itself, the virus remains in the body by hiding inside of immune cells. This hidden virus is referred to as the "latent reservoir." Researchers on this team are studying whether stimulating the immune system can change the nature of the latent reservoir and if this could help people control HIV without the need to take regular HIV medicine.
This study is testing a drug called N-803. N-803 is also known as Interleukin-15 or "IL-15", a powerful and long lasting protein that can affect the immune system by stimulating immune cells such as CD8+ T cells and natural killer (NK) cells. CD8+ T cells and NK cells are both crucial for eliminating infected cells. The drug is FDA-approved for the treatment of bladder cancer, but in this study the drug is being used experimentally for HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-803 | Experimental | Drug: N-803Participants in this arm will receive the active study drug during the blinded portion (Phase A) of the trial. They will receive the active study drug during the open-label portion (Phase B) of the trial. |
| Placebo | Placebo comparator | Drug: Saline placeboParticipants in this arm will receive placebo during the blinded portion (Phase A) of the trial. They will receive the active study drug during the open-label portion (Phase B) of the trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 and ≤ 70 years at the time of screening
- Documented HIV-1 infection
- On continuous ART for at least 6 months without any interruptions of greater than 14 consecutive days within the preceding 6 months
- Plasma HIV RNA levels less than 200 copies/mL at each determination in the previous 6 months
- Screening CD4+ T-cell count ≥ 350 cells/mm3
Key exclusion criteria (17 listed)
- On an ART regimen that includes a non-nucleoside reverse transcriptase inhibitor, unable to switch to a different regimen
- Receipt of any long-acting ART medication (e.g., injectable cabotegravir/rilpivirine, lenacapavir) in the two years preceding screening.
- Known resistance to two or more classes of ART drugs and/or the inability to construct another fully suppressive regimen
- Evidence of HIV "elite" control immediately prior to ART initiation
- Screening platelets < 125,000/mm3
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-803This is the active drug. | Drug | N-803 |
| Saline placeboThis is the placebo. | Drug | Placebo |
Primary outcome
Safety - Solicited Adverse Events
Time frame: Within 7 days after dosing.
Frequency and grade of each solicited systemic reactogenicity AE (malaise, participant-measured body temperature, fatigue, headache, chills, nausea, muscle aches/pain, joint pain).
Safety - Unsolicited Adverse Events
Time frame: Within 7 days after dosing.
Frequency and grade of unsolicited AEs.
1 secondary outcome
Time to Rebound
Time frame: 52 weeks after treatment interruption.
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 22 Jan 2026.
- Individual participant dataSharing planned: Yes. A de-identified data set with longitudinal clinical data will be shared upon the publication of the study results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-803 in people with HIV, run by Michael Peluso, MD 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 6 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 22 Jan 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety - Solicited Adverse Events (time frame: Within 7 days after dosing.). The study lists 2 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 22 Jan 2026.