NCT07145164Enrolling by invitationPhase 2
Interleukin-15 to Promote Post-ART Control of HIV
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- Aug 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Michael Peluso, MD
- Diseases
- HIV
- NCT number
- NCT07145164
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From Aug 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) in the partner, with sexual partners not known to have HIV
Lab values
- Screening platelets \< 125,000/mm3
- Screening hemoglobin \< 12.5 g/dL for men and \<11.5 for women
- QTc interval \>450msec (male) or \>470msec (female)
Other
- Pregnant, breastfeeding, or unwilling to use contraception to prevent pregnancy during participation in the study and until 6 months resumption of ART
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.