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

Inclusion criteria

• ✓. At least 18 years of age on the day of Screening.
• ✓. 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.
• ✓. 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.
• ✓. Screening plasma HIV-1 RNA \< 50 copies/mL
• ✓. CD4+ T cell count \>350 cells/mm3
• ✓. Laboratory values obtained within 35 days prior to the first dose:
• ✓. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
• ✓. In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed.