Inclusion Criteria (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).
* Weight: Cohort A ≥55 and ≤110 kg, Cohort B ≥55 and ≤90 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.
Exclusion Criteria (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.
* 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.
* Known history and/or documented: pre-HIV treatment nadir CD4+ T cell count \<200 cells/mm3 or post-suppressive HIV treatment confirmed CD4+ T cell \<200 cells/mm3 prior to screening
* 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.
* Predefined abnormal laboratory values within 42 days of dosing per protocol
* 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.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov