This study is accepting new patients by invitation only

Interleukin-15 to Promote Post-ART Control of HIV

a study on HIV/AIDS

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Michael Peluso
Headshot of Michael Peluso
Michael Peluso

Description

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 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.

Keywords

HIV, IL-15, N-803, Anktiva, ALT-803

Eligibility

You can join if…

Open to people ages 18-70

  • 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

You CAN'T join if...

  • 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

Location

  • UCSF
    San Francisco California 94044 United States

Lead Scientist at UCSF

  • Michael Peluso
    I am an infectious disease clinician and researcher. My primary interests are HIV cure and Long COVID. For HIV, I am involved with clinical and laboratory research aimed at understanding the HIV reservoir and implementing clinical trials to disrupt the reservoir with the aim of inducing antiretroviral therapy-free HIV remission.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Michael Peluso, MD
ID
NCT07145164
Phase
Phase 2 HIV/AIDS Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated