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Enrolling by invitation NCT07145164

Interleukin-15 to Promote Post-ART Control of HIV

Phase II Interventional HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N-803, Saline placebo.
Who it may be relevant to
Registry conditions: HIV. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug N-803
    This is the active drug.
  • Drug Saline placebo
    This is the placebo.

Primary outcome measures

  • Safety - Solicited Adverse Events [Time frame: Within 7 days after dosing.]
  • Safety - Unsolicited Adverse Events [Time frame: Within 7 days after dosing.]
Secondary outcome measures (1)
  • Time to Rebound [Time frame: 52 weeks after treatment interruption.]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCSF — San Francisco

Identifiers

NCT: NCT07145164 · 25-44404

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗