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
TaiMed Biologics Inc.
75 participants
Dec 16, 2025
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
Plain Language Summary
Simplified for easier understanding
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
A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously
A broadly neutralizing antibody (bNAb) against HIV to be given intravenously
Baseline ART to be taken daily and orally
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT07215468