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NCT07145164

Interleukin-15 to Promote Post-ART Control of HIV

Enrolling by Invitation
PHASE2Ages 18–70InterventionalTreatment
Michael Peluso, MD
~20 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:N-803Saline placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety - Solicited Adverse Events
Measured over Within 7 days after dosing.
+1 more outcome measured

Conditions

HIV

Explore related trials

HIV Infection

Where it's being run

1 sites across 1 states
California1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
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

What this trial measures

  • Safety - Solicited Adverse EventsWithin 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 EventsWithin 7 days after dosing.

    Frequency and grade of unsolicited AEs.