Clinical Trial

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

Study acronym: VISTA
Active, Not Recruiting Phase 2
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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
Protocol Amendment History 4 changes
notable Primary completion moved earlier: 2027-08 -> 2027-05 2026-08-07
minor Completion moved earlier: 2027-08 -> 2027-05 2026-08-07
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-29
notable Enrollment increased: 75 -> 88 participants 2026-05-29
Trial Details
NCT Number NCT07215468
Lead Sponsor TaiMed Biologics Inc.
Conditions HIV -1 Infection
Enrollment 88 participants
Start Date 2025-12-16
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-06