Interleukin-15 to Promote Post-ART Control of HIV
NCT07145164 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-01-22
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.
Conditions
Interventions
- DRUG
-
N-803
This is the active drug.
- DRUG
-
Saline placebo
This is the placebo.
Sponsors & Collaborators
-
amfAR, The Foundation for AIDS Research
collaborator OTHER -
Michael Peluso, MD
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-19
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
HIV Reservoir Reduction With Interleukin-2
NCT03308786 ·Status: TERMINATED ·Phase: PHASE2
-
An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
NCT00004978 ·Status: COMPLETED ·Phase: PHASE3
-
Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
NCT00058734 ·Status: COMPLETED ·Phase: PHASE1
-
Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals
NCT03225118 ·Status: COMPLETED
-
Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV Drugs
NCT00099671 ·Status: COMPLETED ·Phase: PHASE1
-
Umbrella Study for HIV Infected Adults Enrolled in NIAID-Funded Interleukin-2 Studies
NCT00311688 ·Status: COMPLETED
-
Immune Response to a Therapeutic HIV Vaccine Followed by Treatment Interruption in Patients With Acute or Recent HIV Infection
NCT00183261 ·Status: COMPLETED ·Phase: PHASE2
-
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
NCT00029445 ·Status: RECRUITING
-
Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
NCT00080106 ·Status: COMPLETED ·Phase: PHASE2
-
Reducing Proviral HIV DNA With Interferon-a
NCT02227277 ·Status: UNKNOWN ·Phase: PHASE2
-
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study
NCT00002037 ·Status: COMPLETED ·Phase: NA
-
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
NCT00039689 ·Status: RECRUITING
-
Safety of and Immune Response to an Investigational HIV-1 Vaccine With or Without Interleukin-12 (IL-12) in HIV-1 Infected Adults
NCT01266616 ·Status: COMPLETED ·Phase: PHASE1
-
Therapeutic HIV Vaccine and Interleukin-2 to Increase the Immune System's Response to HIV
NCT00056797 ·Status: COMPLETED ·Phase: PHASE2
-
Immune and Viral Outcomes of HIV-1 Therapy Interruption
NCT00051818 ·Status: COMPLETED ·Phase: PHASE1
-
Lymphocyte Infusions for the Treatment of HIV-Infected Patients Failing Anti-HIV Therapy
NCT00559416 ·Status: TERMINATED ·Phase: PHASE1
-
Study Evaluating Vaccine in Adults With HIV
NCT00195312 ·Status: TERMINATED ·Phase: PHASE1
-
Therapeutic Vaccine for HIV
NCT01859325 ·Status: COMPLETED ·Phase: PHASE1
-
Mesalamine to Reduce T Cell Activation in HIV Infection
NCT01090102 ·Status: COMPLETED ·Phase: PHASE4
-
Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients With HIV
NCT00011011 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Immunomodulation of HIV-1 Infected Individuals With PEG-Interleukin-2
NCT00002017 ·Status: COMPLETED ·Phase: NA
-
Subcutaneously Administered Interleukin-12 Therapy in HIV-Infected Patients With Disseminated Mycobacterium Avium Complex Infection
NCT00001763 ·Status: COMPLETED ·Phase: PHASE1
-
Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
NCT00050284 ·Status: COMPLETED
-
A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients With CD4 Cell Counts Less Than 50 Cells/mm3 or 300-500 Cells/mm3
NCT00000857 ·Status: COMPLETED ·Phase: PHASE1
-
Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
NCT00107549 ·Status: COMPLETED ·Phase: PHASE1