NCT05612178Active, not recruitingPhase 1

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

A Randomized Placebo-controlled 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

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 105 (actual)
First submitted: 9 Nov 2022
Start date: 26 Jul 2023
Primary completion date: 31 Mar 2027
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Diseases: HIV
NCT number: NCT05612178

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 105
From 26 Jul 2023 to the primary completion date, 31 Mar 2027
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

History of AIDS-defining illness within 3 years prior to enrollment;
Participants with known hypersensitivity to any constituent of the investigational products;
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);
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.

Other illness

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;
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);
Any history of receipt of HIV-1 mAb therapy or HIV vaccine;
Inability to undergo leukapheresis due to poor venous access or other medical conditions;

Lab values

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

Other

An individual who meets any of the following criteria will be excluded from participation in this study:
Pregnancy or lactation;

Criteria the registry did not label

INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Ability to provide informed consent;
Stated willingness to comply with all study procedures and availability for the duration of the study;
Adult persons of any sex or gender, aged 18 years to 70;
Confirmed HIV-1 infection and clinically stable;
On antiretroviral therapy with plasma HIV-1 RNA levels of \< 50 copies/mL and no reported interruption of ART for 7 consecutive days or longer for at least 96 weeks. NOTE: At least two viral load (VL) measurements within 48 weeks prior to the screening visit must be available for review. A single plasma HIV-1 RNA \> 50 copies/mL but \< 200 copies/mL over 48 weeks that is followed by an HIV-1 RNA \< 50 copies/mL is permitted;
Current CD4+ T cell counts \> 300 cells/mcL;
For participants who can become pregnant (i.e., participants who have not been postmenopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy), must have a negative pregnancy test at screening and within 48 hours prior to day 0; NOTE: Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy.
Participants who can become pregnant must agree to use adequate measures to prevent pregnancy. This includes the use an effective method of contraception for the study duration. Contraception must be used from 10 days prior to the first dose of the investigational products (IPs), while receiving the IPs and during study follow up. Acceptable methods of contraception include:
- Contraceptive subdermal implant
- Intrauterine device or intrauterine system
- Combined estrogen and progestogen oral contraceptive
- Injectable progestogen
- Contraceptive vaginal ring
- Percutaneous contraceptive patches
- NOTE: Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant, will be allowed. The documentation of partner sterility can come from the site personnel s review of medical records, medical examination and/or semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.
Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to the first dose of the IPs, while receiving the IPs and during study follow up to avoid impregnating a partner who can get pregnant.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Unknown status
The Rockefeller University Coordinator of this site? Confirm its status	New York	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.