Immunologic and Virologic Parameters During Analytical Treatment Interruption Following Combination bNAb Therapy During Suppressive ART

Enrolling by invitation · Phase 1

Conditions studied: HIV

In brief

Background: Recent studies have shown bNAbs may help remove cells that are infected with HIV (HIV reservoir) from the body and may also change how the immune system fights HIV. Objective: The purpose of this research study is to see if and when HIV levels in the blood (viral load) rise after the participant stops their HIV medication. We will also measure the highest number (peak) of the virus before each participant starts their HIV medications again. For most people treated with standard HIV medications, the HIV virus amount will increase within 2 to 4 weeks after stopping their HIV medications. This study is only open to participants who have taken part in an earlier study (MCA-1034 or NIH number 001037). In the earlier study, participants either received a combination of 3BN117-LS and 10-1074-LS (two anti-HIV monoclonal antibodies) OR received placebo (salt water). In this new study, researchers will compare the participants who received the antibodies to those who did not to see what effect the antibodies may have had on the HIV reservoir. Researchers will also look at: * side effects people may have when they stop their HIV medications. * changes in the number of blood cells carrying inactive HIV (the HIV reservoir size). * the blood cells that can clear HIV before, following temporarily stopping, and after re-starting HIV medications. * how well HIV may be controlled after a participant stops their HIV medication. Eligibility: People aged 18 to 70 years with HIV who completed protocol MCA-1034 (NIH Study 001037). Design: Participants will be screened. They will have a physical exam. They will answer questions about their health. Blood samples will be taken. Participants will stop their HIV medications for a period of time. They will have blood tests every 2 weeks and clinic visits every 4 weeks for 24 weeks to check their HIV levels and to make sure they are not having side effects. There will be strict safety rules for restarting HIV medications. Some participants whose HIV levels remain low at 24 weeks may continue without ART for another 24 weeks; they will have blood tests every 2 to 4 weeks. Participants may undergo leukapheresis up to 3 times: Leukapheresis is a several hours long procedure in which blood is collected from a vein in one arm, processed through an attached machine, and then returned to the person through a vein in the opposite arm. Participants will have 4 follow-up visits over 24 weeks after they restart ART. Participants will remain in the study up to 18 months.

Key facts

Study ID: NCT06908083
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 50
Starts: 2025-09-08
Expected to finish: 2028-06-30
Last updated by the study team: 2026-06-01

Who can join

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

You may not qualify if…

Any individual who meets any of the following criteria will be excluded from participation in this study:
History of AIDS-defining illness and/or known CD4 nadir less than 100 cells/mcL in the last 3 years;
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 3 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;
History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2018 ACC/AHA guidelines, including a previous diagnosis of any of the following:
Acute myocardial infarction
Acute coronary syndromes
Stable or unstable angina
Coronary or other arterial revascularization procedures
Stroke
Transient ischemic attack
Peripheral arterial disease presumed to be of atherosclerotic origin;
Any history of an HIV-associated malignancy, including Kaposi's sarcoma, or any type of lymphoma or virus-associated cancers;
Any history of Progressive Multifocal Leukoencephalopathy (PML);
Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; NOTE: minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) is not exclusionary.
Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or isolated positive HBV core antibody 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; as are participants with isolated HBcAb who are receiving an ART regimen that do not include tenofovir (TAF or TDF).
Pregnancy or lactation;
Receipt of cabotegravir-LA IM or rilpivirine-LA IM within 24 months prior to study entry.
Documented multiclass antiretroviral drug resistance that, in the judgment of the investigator, would pose a risk of virologic failure should additional mutations develop during the study;
Laboratory abnormalities in the parameters listed below:
Absolute neutrophil count <1,000 cells/mcl;
Hemoglobin <10 gm/dL;
Platelet count <100,000 cells/mcl;
ALT >1.5 x ULN;
AST >1.5 x ULN;

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Rockefeller Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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