drugset / Trial / NCT07215468

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

NCT07215468

Phase 2 Active not recruiting 88 enrolled TaiMed Biologics Inc.
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2025-12-16
Primary completion
2027-08
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Subject TMB-365 Monoclonal antibody Intravenous
Subject VRC07-523LS Monoclonal antibody Intravenous