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Interleukin-15 to Promote Post-ART Control of HIV | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE2

Interleukin-15 to Promote Post-ART Control of HIV

NCT07145164•Michael Peluso, MD

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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)
+7 more criteria

Locations (1)

UCSF

San Francisco, California, United States

Key Dates

Start Date

August 19, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2028

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

HIV

Interventions

N-803

DRUG

Saline placebo

DRUG

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

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RECRUITINGPHASE3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Interleukin-15 to Promote Post-ART Control of HIV

Inclusion Criteria

Exclusion Criteria

Thinking and Memory Problems in People With HIV

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption