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

NCT07215468 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-13

No results posted yet for this 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

Conditions

  • HIV -1 Infection

Interventions

DRUG

TMB-365

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

DRUG

TMB-380

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

DRUG

Baseline ART

Baseline ART to be taken daily and orally

Sponsors & Collaborators

  • TaiMed Biologics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215468 on ClinicalTrials.gov