Actively Recruiting
HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study
Led by TaiMed Biologics Inc. · Updated on 2026-04-13
75
Participants Needed
10
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age on the day of Screening.
- Diagnosed with asymptomatic HIV-1 infection confirmed by licensed HIV tests.
- On continuous suppressive combination antiretroviral therapy (cART) for at least 6 months prior to Screening with HIV-1 RNA level less than 50 copies/mL within 6 months.
- Stable oral cART regimen for at least 3 months prior to Screening.
- Screening plasma HIV-1 RNA less than 50 copies/mL.
- CD4+ T cell count greater than 350 cells/mm3.
- Hemoglobin at least 10.0 g/dL, platelet count at least 100,000/mm3, absolute neutrophil count at least 1,000/mm3.
- Liver enzymes (AST and ALT) less than 1.5 times the upper limit of normal.
- Creatinine clearance of at least 50 mL/min.
- Willingness to comply with study protocol and availability for follow-up.
- Provided written informed consent.
- Persons of childbearing potential must agree to use effective contraception and pregnancy testing as per study requirements.
You will not qualify if you...
- Previous receipt of any monoclonal antibody for HIV treatment or prevention.
- Receiving cabotegravir and rilpivirine intramuscularly as maintenance therapy for HIV-1.
- Pregnant, planning pregnancy during the trial, or lactating.
- Known allergy or hypersensitivity to study drugs or monoclonal antibodies.
- History of severe allergic reactions to medications, vaccinations, or monoclonal antibody therapy.
- Major psychiatric illness including schizophrenia, severe psychosis, uncontrolled bipolar disorder, or recent suicide attempt.
- Serious illness requiring systemic treatment or hospitalization within 21 days prior to Baseline.
- Use of immunomodulatory agents, HIV vaccine, systemic chemotherapy, or investigational therapy within 180 days prior to Baseline.
- Chronic or acute medical conditions interfering with study evaluation, including chronic Hepatitis B or C with viremia, drug or alcohol abuse.
- Lack of adequate venous access.
- History of virologic failure on two or more cART regimens or treatment with ibalizumab, enfuvirtide, maraviroc, or fostemsavir.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Quest Clinical Research
San Francisco, California, United States, 94115
Actively Recruiting
2
CAN Community Health Fort Lauderdale
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
3
Midway Immunology and Research Center (MIRC)
Ft. Pierce, Florida, United States, 34982
Actively Recruiting
4
CAN Community Health Miami Gardens
Miami Gardens, Florida, United States, 33055
Actively Recruiting
5
Midland Medical
Oakland Park, Florida, United States, 33334
Actively Recruiting
6
Orlando Immunology Center
Orlando, Florida, United States, 32803
Actively Recruiting
7
CAN Community Health Sarasota
Sarasota, Florida, United States, 34237
Actively Recruiting
8
CAN Community Health Las Vegas
Las Vegas, Nevada, United States, 89104
Actively Recruiting
9
The Rockefeller University
New York, New York, United States, 10065
Actively Recruiting
10
The Crofoot Research Center, Inc.
Houston, Texas, United States, 77098
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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