RecruitingPhase 2NCT07215468

HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study

A Phase 2b Study of the Safety, Pharmacokinetics, and Efficacy of the Combination of TMB-365 and TMB-380 as Maintenance Therapy in HIV-1 Infected Individuals Suppressed With Combination Antiretroviral Therapy


Sponsor

TaiMed Biologics Inc.

Enrollment

75 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test the combination of the antibodies as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 48 weeks. Researchers will compare TMB-365/TMB-380 given IV every 8 weeks to continuation of daily oral cART to see if TMB-365/TMB-380 can also maintain viral suppression. Participants will: 1. Receive TMB-365/TMB-380 infusion or take oral cART as scheduled for 48 weeks 2. Visit the clinic as schedule for checkups and tests


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two antibody-based treatments (TMB-365 and TMB-380) as a replacement for daily HIV pills in people living with HIV-1 whose viral load is already well controlled on their current medications. **You may be eligible if...** - You are 18 or older and have HIV-1 - You have been on continuous HIV treatment for at least 6 months with an undetectable viral load (under 50 copies/mL) - Your CD4+ T cell count is at least 350 cells/mm³ - Your blood counts, liver, and kidney function are within acceptable ranges - You are willing to use contraception if applicable **You may NOT be eligible if...** - You have previously received monoclonal antibody treatment for HIV - You are currently receiving injectable HIV treatment (cabotegravir/rilpivirine) - You have a history of virologic failure on two or more HIV treatment regimens - You are pregnant, planning a pregnancy, or breastfeeding - You have hepatitis B or C infection, or a serious ongoing illness - You have a history of severe allergic reactions to monoclonal antibodies or vaccines Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTMB-365

A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously

DRUGTMB-380

A broadly neutralizing antibody (bNAb) against HIV to be given intravenously

DRUGBaseline ART

Baseline ART to be taken daily and orally


Locations(10)

Quest Clinical Research

San Francisco, California, United States

CAN Community Health Fort Lauderdale

Fort Lauderdale, Florida, United States

Midway Immunology and Research Center (MIRC)

Ft. Pierce, Florida, United States

CAN Community Health Miami Gardens

Miami Gardens, Florida, United States

Midland Medical

Oakland Park, Florida, United States

Orlando Immunology Center

Orlando, Florida, United States

CAN Community Health Sarasota

Sarasota, Florida, United States

CAN Community Health Las Vegas

Las Vegas, Nevada, United States

The Rockefeller University

New York, New York, United States

The Crofoot Research Center, Inc.

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07215468


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