Therapeutic Vaccination in Treated HIV Disease

Inclusion Criteria:

1. Willing and able to provide written informed consent

2. Male or female, age ≥ 18 and ≤ 65 years

3. 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 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 or plasma HIV-1 RNA viral
load.

4. For Cohort A participants, ART initiated during chronic infection (e.g., more than 6
months after estimated date of infection, or as determined by site investigator and/or
available medical records).

5. For Cohort B participants, ART initiated during "hyperacute" HIV infection (Fiebig
I/II) or early HIV infection (Fiebig III/IV).

6. On continuous antiretroviral therapy for at least 24 months without any interruptions
of greater than 14 consecutive days, and on a stable regimen for at least 8 weeks,
without plans to modify ART during the study period

7. Screening plasma HIV RNA levels < 40 copies/mL on all available determinations in past
24 months (isolated single values ≥ 40 but < 200 copies/mL will be allowed if they
were preceded and followed by undetectable viral load determinations)

8. Screening CD4+ T-cell count ≥ 350 cells/mm3

9. Creatinine Clearance (CrCl) > 60 mL/min via Cockroft-Gault method at screening

10. The following laboratory criteria must be met at screening:

- Absolute neutrophil count (ANC) ≥ 1000 neutrophils/mm3

- Hemoglobin ≥ 10.0 g/dL

- Platelet count ≥ 100,000/uL

- Aspartate aminotransferase (AST) ≤ 2x upper limit of normal (ULN)

- Alanine aminotransferase (ALT) ≤ 2x ULN

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in
the study

a. Acceptable birth control is defined as the following: i. For female participants of
childbearing potential, two of the following forms of contraception are required, one of
which must be a barrier method:

1. Condoms (male of female) with or without a spermicidal agent 2. Diaphragm or cervical
cap with spermicide 3. Intrauterine device (IUD) with published data showing that expected
failure rate is < 1% per year 4. Tubal ligation 5. Hormone-based contraceptive such as oral
birth control pills ii. Male participants participating in sexual activity that could lead
to pregnancy must agree to at least one reliable method of contraception of the above
listed 2. Active malignancy requiring systemic chemotherapy or surgery in the preceding 3
months or for whom such therapies are expected in the subsequent 6 months 3. Active
(untreated) HCV or HBV infection 4. Decompensated liver disease as defined by the presence
of ascites, encephalopathy, esophageal or gastric varices, or persistent jaundice 5.
Serious illness requiring systemic treatment and/or hospitalization in the 3 months prior
to study enrollment 6. Concurrent treatment with immunomodulatory drugs, and/or exposure to
any immunomodulatory drug in the 4 weeks prior to study enrollment (e.g. corticosteroid
therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days,
IL-2, interferon-alpha, methotrexate, cancer chemotherapy). NOTE: use of inhaled or nasal
steroid is not exclusionary.

7. Serious medical or psychiatric illness that, in the opinion of the site investigator,
would interfere with the ability to adhere to study requirements or to give informed
consent.

8. Active drug or alcohol use or dependence that, in the opinion of the site investigator,
would interfere with adherence to study requirements or to give informed consent.

9. Unable to undergo leukapheresis procedure 10. Acute or chronic bleeding or clotting
disorder that would contraindicate IM injections or use of blood thinners (e.g.
anticoagulants or antiplatelet drugs) within 2 weeks of Day 0; 11. Less than two acceptable
sites available for IM injection considering the deltoid and anterolateral quadriceps
muscles; 12. Tattoos, keloids or hypertrophic scars located within 2 cm of intended
treatment site; 13. Cardioverter-defibrillator or pacemaker (to prevent a life-threatening
arrhythmia) that is located in ipsilateral deltoid injection site (unless deemed acceptable
by a cardiologist); 14. Metal implants or implantable medical device within the intended
treatment site (i.e. electroporation area)