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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously
A broadly neutralizing antibody (bNAb) against HIV to be given intravenously
Baseline ART to be taken daily and orally
Quest Clinical Research
San Francisco, California, United States
CAN Community Health Fort Lauderdale
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center (MIRC)
Ft. Pierce, Florida, United States
CAN Community Health Miami Gardens
Miami Gardens, Florida, United States
Midland Medical
Oakland Park, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
CAN Community Health Sarasota
Sarasota, Florida, United States
CAN Community Health Las Vegas
Las Vegas, Nevada, United States
The Rockefeller University
New York, New York, United States
The Crofoot Research Center, Inc.
Houston, Texas, United States
Antiviral activity of TMB-365 and TMB-380 as maintenance therapy compared to daily oral cART
% 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
Time frame: Week 48
Number of participants who experience protocol-defined virologic failure
Virologic failure is defined as two consecutive plasma HIV-1 RNA levels ≥200 copies/mL obtained at least 2 weeks apart.
Time frame: 48 weeks
Pharmacokinetic profile of TMB-365
Mean trough concentrations for TMB-365 in Experimental Arm
Time frame: Week 48
Pharmacokinetic profile of TMB-380
Mean trough concentrations for TMB-380 in Experimental Arm
Time frame: Week 48
Safety of maintenance treatment regimen
Number of participants experience grade 3, grade 4, or serious adverse reactions related study treatment.
Time frame: 48 weeks
Immune effects of maintenance therapy
Changes in CD4+ cell counts (cells/mm3) from baseline to Week 48
Time frame: 48 weeks
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