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

Open to males ages 18-60

(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 60 years (both inclusive).
• Body weight ≥45 and ≤90 kg.
• Cohort A will only enroll male subjects (sex at birth).
• Documented chronic HIV-1 infection with the following management status criteria: on a stable regimen defined as continuous ART treatment for >2 years prior to screening; no interruptions within the last 12 months greater than 14 consecutive days; no changes in regimen or doses for >90 days prior to the planned dosing date; regimen will be maintained throughout the study duration.
• Plasma HIV-1 RNA levels below the limit of quantification: on all available results in past 12 months (isolated single values ≥20 but <200 copies/mL will be allowed if they were preceded and followed by undetectable viral load results); within 60 days prior to the planned dosing date; peripheral blood CD4 T cell count >500 cells/mm3 within 60 days prior to the planned dosing date.
• Normal laboratory values in hematology, hepatic, renal and other systems for lab safety 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 vaccine, 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.
• Receiving or have plans to start 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 known cardiovascular event in the past year or history of HIV-related cardiac disease.
• History of HIV-related kidney disease with abnormal renal function.
• History of one or more HIV-related opportunistic infections or within the past 2 years.
• Evidence of acute or chronic hepatitis B (positive serum hepatitis B surface antigen [HBsAg], positive serum hepatitis B core antibody [anti-HBcAb]) and/or hepatitis C (detectable plasma HCV-RNA).
• Known history or diagnosis of liver cirrhosis, nonalcoholic fatty liver or advanced nonalcoholic steatohepatitis.
• 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 30 days prior to screening and/or persistent (long) COVID-19-related symptoms during screening.