HIV/AIDS Clinical Trials

• Able and willing to provide informed consent. Participants must be willing and able to comply with study procedures

• Able and willing to provide adequate locator information

• Able and willing to comply with all study requirements through Day 28

• Agrees not to enroll on another study of an investigational agent during the study period, defined as any unlicensed investigational drug not yet approved for use in humans

• Aged ≥ 18 years and ≤ 70 years of age, at the time of informed consent

• HIV 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 a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral assay.

• NOTE: The term licensed refers to a US FDA-approved kit, which is required for all Investigational New Drug (IND) studies. World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment.

• Plasma HIV-1 RNA viral load must meet the following conditions:

∙ \< 50 copies/mL at 2 time points within 12 months prior to screening

‣ \< 50 copies/mL at screening

‣ Not \> 1000 copies/mL at any time within 6 months prior to screening

• On continuous ART for at least 24 months prior to screening and must continue ART throughout the study. Permitted ART regimens include:

∙ At least 3 ART drugs, one ART drug must include an integrase inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI), efavirenz excluded (see 5.2) or

‣ At least 2 ART drugs including injectables, in which one drug is an integrase inhibitor that is FDA approved or recommended by Department of Health and Human Services Treatment Guidelines.

• NOTE: Other potent fully suppressive antiretroviral combinations will be considered on a case-by-case basis.

• NOTE: No changes or modifications of ART dosing allowed within 30 days prior to screening.

• CD4 cell count \> 350 cells/mm3 at screening

⁃ Hepatitis C virus (HCV) antibody negative or HCV RNA negative at screening

⁃ Hepatitis B surface antigen negative at screening

⁃ Clinical laboratory parameters obtained at screening as follows:

• Platelet count ≥ 125 × 103/µL

∙ Absolute neutrophil count ≥ 1.5 × 103/µL

∙ Absolute Lymphocyte levels ≥ 1000 cells/uL

∙ Hemoglobin ≥ 12 g/dL (male) and ≥ 11 g/dL (females)

∙ Prothrombin time or international normalized ratio (INR) ≤ 1.1 × upper limit of normal (ULN)

∙ Serum total bilirubin ≤ 1.5 × ULN. If total bilirubin is elevated, direct bilirubin ≤ 2 × ULN. If ART includes atazanavir, direct bilirubin must be ≤ 1.0 mg/dL

∙ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN

∙ Alkaline phosphatase (ALP) ≤ 1.5 × ULN

∙ Serum glucose (fasting or non-fasting) ≤ Grade 1

• Lipase ≤ 1.5 × ULN

• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min as determined by the 2021 Chronic Kidney Disease Epidemiology Collaboration equation (CKD-Epi equation) found at: https://www.mdcalc.com/calc/3939/ckd-epi-equations-glomerular-filtration-rate-gfr

• Negative serum pregnancy test for women of childbearing potential (WOCBP) with a sensitivity of at least 25 milli-International Units (mIU)/mL at screening

⁃ All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) starting with screening visit through 30 days after receiving study drug

⁃ WOCBP, defined as female at birth, is not pregnant, expecting to become pregnant, or breastfeeding or participant assigned male at birth is not expecting to father children, starting with screening visit through 30 days after receiving study product

⁃ WOCBP, not surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy), and not post-menopausal for at least 24 consecutive months, i.e., have had menses within the preceding 24 months, must have a negative serum pregnancy test performed within 72 hours prior to initiation of study drug

⁃ WOCBP and male participants of reproductive potential with WOCBP partners must agree to consistently use a highly effective method of contraception and a barrier method (condom, diaphragm or cervical cap) for the duration and for 30 days afterwards. Highly effective methods include the following:

⁃ Highly effective methods include:

‣ Contraceptive subdermal implant

‣ Intrauterine device or intrauterine system

‣ Combined estrogen and progestogen oral contraceptive

‣ Injectable progestogen

‣ Contraceptive vaginal ring

‣ Percutaneous contraceptive patches

‣ True sexual abstinence (only if it is the participant's consistent lifestyle choice and not just trial-related).

‣ Sterilization of male partner with documentation of azoospermia prior to the participant's entry into the study, and this individual is the sole partner for the participant. The documentation of partner sterility can come from the site personnel's review of medical records, medical examination and/or semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.

⁃ Barrier method may include:

‣ Male or female condoms with or without a cream or gel that kills sperm

‣ Diaphragm or cervical cap with a cream or gel that kills sperm

‣ Sponge

⁃ Participants not of reproductive potential are eligible without requiring the use of contraceptives. Acceptable documentation are specified below.

⁃ NOTE: Men who have sex with men only will not be required to use contraception NOTE: Women who have sex with women only will not be required to use contraception

⁃ NOTE: Written/oral documentation communicated by clinician/clinician's staff of one of the following:

∙ Physician report/letter

∙ Operative report or other source documentation in the patient record (a laboratory report of azoospermia is required to document successful vasectomy)

∙ Discharge summary

∙ Follicle stimulating hormone-release factor (FSH) measurement elevated into the menopausal range as established by the reporting laboratory

⁃ Willingness to defer vaccinations, including influenza and Coronavirus Disease (COVID-19) vaccines, from 30 days prior to Day -1 through Day 28 post-infusion

⁃ Willingness to abstain from alcohol, illicit drugs and grapefruit juice and limit caffeine intake from 24 hours prior to study treatment through Day 7

⁃ Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests

⁃ Body mass index of less than 35