A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: HIV-1

In brief

Background: Antiretroviral therapy (ART) can suppress HIV to undetectable levels in people, but the virus rebounds quickly if the drug treatment is stopped; this is because HIV can remain dormant in a pool of blood cells called the persistent viral reservoir (PVR). Yet lifelong ART is expensive and can lead to serious side effects over the long term. Some drugs may be more effective at reducing the PVR. Objective: To see if 2 study drugs (3BNC117-LS and 10-1074-LS) are safe and if they can lower the number of HIV-infected blood cells in people with HIV who are on ART. Eligibility: People aged 18 to 70 years with HIV who are on ART. Design: Participants will be screened. They will have a physical exam and blood and urine tests. They will undergo leukapheresis. Leukapheresis is a procedure where blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm. The study drugs or placebo (normal saline) will be administered 3 times at 20-week intervals. The drugs will be given through a tube attached to a needle inserted into a vein in the arm. This will take 1 hour. Some participants will receive only a saline solution. They will not know if they are getting the drugs or the placebo. Participants will undergo leukapheresis up to 4 more times during the study. Participants will have follow-up visits every 10 weeks until the study ends.

Key facts

Study ID

NCT05612178

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

105

Starts

2023-07-26

Expected to finish

2027-03-31

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• History of AIDS-defining illness within 3 years prior to enrollment;
• History of systemic corticosteroids (e.g., an equivalent dose of prednisone of > 20 mg daily for >14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 6 months;
• Any clinically significant acute or chronic medical condition (e.g. such as autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation;
• Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood. NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible;
• Participants with known hypersensitivity to any constituent of the investigational products;
• Pregnancy or lactation;
• ART initiated during acute infection (defined as p24, HIV nucleic acid amplification technique [NAAT], or HIV RNA PCR positive, and negative or indeterminate HIV antibody testing);
• Laboratory abnormalities in the parameters listed below:
• Absolute neutrophil count < 1,000 cells/microliter
• Hemoglobin < 10 gm/dL
• Platelet count < 100,000 cells/microliter
• ALT > 1.5 x ULN
• AST > 1.5 x ULN
• Total bilirubin > 1.5 x ULN
• Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m\^2
• Any history of receipt of HIV-1 mAb therapy or HIV vaccine;
• Participation in any clinical study of an investigational product within 12 weeks prior to study entry (day 0) or expected participation in such a study during this study;
• Any approved or experimental non-HIV vaccination (e.g., SARS-CoV-2, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment (day 0);
• Inability to undergo leukapheresis due to poor venous access or other medical conditions;
• Active drug or alcohol use or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• The Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

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