HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study
Trial Parameters
Eligibility Fast-Check
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Brief 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
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age on the day of Screening. 2. Asymptomatic HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by Geenius™ or a second antibody test by a method other than the initial rapid HIV and/or E/CIA test, or by HIV-1 antigen, plasma HIV-1 RNA viral load at or prior to screening. 3. On continuous suppressive cART for at least 6 months prior to Screening with one documented HIV-1 RNA level \<50 copies/mL within 6 months of Screening. Continuous cART is defined as no interruptions greater than 3 consecutive days. cART is defined as a DHHS recommended regimen. Study participants should be on a stable oral regimen for at least 3 months prior to Screening. 4. Screening plasma HIV-1 RNA \< 50 copies/mL 5. CD4+ T cell count \>350 cells/mm3 6. Laboratory values obtained within 35 days prior to the first dose: * Hemoglobin ≥ 10.0 g/dL * Plate