Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART

Open to males ages 18-70

(abbreviated):

- Willing to enroll and sign the written informed consent for EBT-101-001 (current study) and EBT-101-002, the LTFU study. - Age between 18 and 70 years (both inclusive). - Body weight ≥55 and ≤110 kg. - Cohorts A and B will only enroll male subjects (sex at birth). - Chronic HIV-1 with known subtype B infection - On stable regimen defined as continuous ART suppressive treatment with HIV RNA level below the level of quantitation for >1 years prior to screening - Plasma HIV-1 RNA levels below the limit of quantitation during screening. - Peripheral blood CD4 T cell count ≥500 cells/mm3 for at least 2 years prior to screening - Willing and able to comply, as assessed by the Investigator, with all study-related procedures. - Have previously been vaccinated for N. meningitidis with documented history and/or received a N. meningitidis vaccination prior to dosing. - Willing to stop ART if eligible for analytical treatment interruption. - Willing to comply with the measures to prevent HIV transmission and reinfection required by the protocol. - Must have received a COVID-19 vaccination series and boosters as specified by current federal (CDC) recommendations, with the last dose ≥30 days prior to dosing.

(abbreviated):

- Documented prior HIV-1 drug resistance to ≥2 or more classes of ART defined as single key mutations or an accumulation of minor mutations that result in resistance to entire respective drug classes within the past 5 years. - History of >1 change in ART due to virologic failure during preceding 2 years prior to screening. - Received in the preceding 12 months or HCP plans to prescribe long-acting injectable ART. - Pregnant or breastfeeding or planning to become pregnant (self or partner) or to breastfeed at any time through 48 weeks post dose. - History of HIV dementia. - History of progressive multifocal leukoencephalopathy. - History of significant cardiac disease in last 2 years. - History of HIV-related kidney disease with abnormal renal function. - History of pre-HIV treatment nadir CD4 T cell count <200 cells/mm3 or post-HIV treatment confirmed CD4+ <200 cells/mm3. - History of AIDS-defining opportunistic infection prior to screening. - Evidence of acute or chronic hepatitis B and/or hepatitis C. - Known history or diagnosis of liver cirrhosis. - Diagnosis of nonalcoholic fatty liver or advanced nonalcoholic steatohepatitis. - Abnormal laboratory values in hematology, hepatic, renal, peripheral blood CD4 T cell count <500 cells/mm3, and other systems for lab safety screening. - Known history of positive tuberculin skin test. - Receipt of any investigational HIV vaccine (prophylactic and/or therapeutic) within the year prior to screening. - Receipt of any gene therapy product approved or experimental, at any time. - Anti-AAV9 serum neutralizing antibodies (Nabs) >1:20 titer. - Known positive SARS-CoV-2 test within 48 hours prior to planned dosing date.