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NCT07215468 · ClinicalTrials.gov registry record · Phase 2
HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study
A Phase 2 study of HIV-1-infection, sponsored by TaiMed Biologics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 11
- Study locations
NCT07215468: Recruiting Phase 2 study of HIV-1-infection, sponsored by TaiMed Biologics.
NCT07215468 is a Phase 2 study of HIV-1-infection that is actively recruiting participants, run by TaiMed Biologics. The registered enrollment target is 75 participants, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower). The trial reports 11 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07215468, a Phase 2 study of HIV-1-infection, is actively recruiting participants, sponsored by TaiMed Biologics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 11
- Study locations
Study 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
Primary Outcome
% of subjects with plasma HIV-1 RNA greater than or equal to 50 c/mL at week 48 by snapshot analysis as defined by US FDA
Conditions Studied
Interventions
- DRUG TMB-365
- DRUG TMB-380
- DRUG Baseline ART
Study Locations (11)
Florida
- CAN Community Health Fort Lauderdale - Fort Lauderdale
- Midway Immunology and Research Center (MIRC) - Ft. Pierce
- CAN Community Health Miami Gardens - Miami Gardens
- Midland Medical - Oakland Park
- Orlando Immunology Center - Orlando
- CAN Community Health Sarasota - Sarasota
California
- Long Beach Education and Research Consultants - Long Beach
- Quest Clinical Research - San Francisco
Georgia
- Mercer University, Department of Internal Medicine, Clinical Research - Macon
Nevada
- CAN Community Health Las Vegas - Las Vegas
Texas
- The Crofoot Research Center, Inc. - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2025-12-16 |
| Est. Completion | 2027-08 |
| Phase | Phase 2 |
What NCT07215468 shows while recruiting
NCT07215468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 350-participant average among 71 other HIV-1-infection trials with a reported enrollment target (79% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 3 interventions - of which TMB-365 is the first listed.
NCT07215468 lists 11 locations in 5 states (Florida, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT07215468 about?
NCT07215468 is a clinical study titled "HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study". 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 disconti...
What is the current status of trial NCT07215468?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2025-12-16. Estimated completion is 2027-08.
What conditions does trial NCT07215468 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT07215468?
The interventions under investigation include: TMB-365 (DRUG), TMB-380 (DRUG), Baseline ART (DRUG).
Who is sponsoring clinical trial NCT07215468?
This trial is sponsored by TaiMed Biologics, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07215468 being conducted?
This trial has 11 study locations across California, Florida, Georgia, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07215468's enrollment target sits among peer trials
75 39th of 71 higher than 32 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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