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

Conditions

• HIV

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Analytical Treatment Interruption — OTHER
  Participants will stop their ART (Antiretroviral therapy) on Week 0 and will remain off of their ART for up to 48 weeks or until they meet restart criteria.

Study Details

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 Dates

Start date

Sep 8, 2025

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Adults living with HIV
  Participants who received either two intravenous infusions of 3BNC117-LS (dosed at 30 mg /kg) and 10-1074-LS (dosed at 10 mg/kg) or two saline infusions (placebo) at weeks 0, and 20 as part of the Rockefeller University trial (MCA-1034) or the NIH trial (001037) and are willing to interrupt treatment and then restart once criteria is met.

Primary Outcome Measure

Time to Restart ART [ Time Frame: Week 0 until Week 48 or when participant meets restart criteria ]

Locations (2)

Find similar trials in Bethesda, MD

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