A Phase I/II Study to Evaluate the Immunologic Response and Virologic Impact of AGS-004

This is a phase I/II, single-site, pilot study of the kinetics of the immunological response
and virological impact of AGS-004 administered in participants with durable viral
suppression on ART initiated during acute (AHI) and chronic HIV infection (CHI). Patients
will be screened for eligibility in Step 1. Those meeting study eligibility and with
successful production of Argos (AGS)-004 product will then enter Step 2 with administration
of AGS-004. All participants will continue ART throughout the study.

Inclusion Criteria:

- Confirmation of HIV-1 infection:

- Chronic HIV infection (CHI) is defined as documentation of a positive HIV test result
by any licensed ELISA test kit and confirmed by Western blot or Multispot HIV-1/HIV-2
assay prior to screening. HIV culture, HIV antigen, plasma HIV RNA, or a second
antibody test by a method other than ELISA is acceptable as an alternative
confirmatory test.

- Acute HIV infection (AHI) is defined as a negative or indeterminate enzyme
immunoassay (EIA) or a negative HIV RNA test within 45 days of reproducibly
detectable plasma HIV RNA by amplification methods.

- Participants in the AHI arm of this study must have initiated ART within 45 days of
AHI diagnosis

- Ages ≥ 18 to < 65 years old

- Stable ART regimen for ≥ 6 months prior to Screening (Visit 1) NOTE: The ART regimen
is defined by current treatment guidelines. Participants may have had one or more
changes in their ART regimen for tolerance, change of guidelines, or dosing
simplification.

- On potent antiretroviral therapy, defined as at least 2 nucleoside/nucleotide reverse
transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor,
integrase inhibitor, or a protease inhibitor. Other potent fully suppressive
antiretroviral combinations will be considered on a case-by-case basis. Prior changes
in or elimination of medications for easier dosing schedule, intolerance, or toxicity
are permitted.

- All participants must continue cART throughout the study.

- Plasma HIV-1 RNA below detected limit by conventional assays (limit of detection
determined by assay employed: 75, 50, 40, or 20 copies/mL) for ≥ 1 year

- A single unconfirmed plasma HIV RNA > limit of detection but < 1000 c/mL allowed if a
subsequent assay was below the limit of detection; but none in the 6 months preceding
the study screening visit.

- Plasma HIV-1 RNA < 50 copies/mL at screening (Visit 1)

- CD4 cell count ≥ 350 cells/mm3 at screening (Visit 1)

- Availability of an adequate sample of frozen plasma (may have been thawed and
re-frozen only once) drawn no more than 90 days (and preferably within 30 days)
before starting ART, OR an adequate frozen sample of HIV p24 antigen-positive culture
supernatant obtained from culture of resting CD4+ T cells.

Note: The VL documented from the pre-ART HIV plasma sample must be ≥8,000 copies/ml before
commencing ART regimen (abstracted from medical records). If there is no viral load
measurement associated with the pre-ART HIV plasma sample, another pre-ART VL measurement
of 8,000 copies/ml can be used to accept the sample for AGS-004 manufacturing.

- No history of auto-immune disease or auto-immune manifestations

- No active HCV infection (measureable HCV RNA) within 90 days of eligibility visit
(visit 3).

- No active HBV infection (measureable HBV DNA or HBVsAg+) within 90 days of
eligibility visit (visit 3).

- Ability and willingness of participant to give written informed consent

- Able and willing to provide adequate locator information

- Ability and willingness to communicate effectively with study personnel; considered
reliable, willing, and cooperative in terms of compliance with the Protocol
requirements

- Adequate vascular access for leukapheresis

- Able and willing to receive Intradermal (ID) injections without difficulty

- All female study participants of childbearing potential must agree not to participate
in a conception process, and, if participating in sexual activity that could lead to
pregnancy, these female participants and their partners must agree to use at least
two reliable forms of contraception for at least 21 days prior to study entry and for
12 weeks after the last dose of the study drug product:

o Acceptable forms of contraception include the following:

- Condoms (male or female) with or without spermicidal agent

- Diaphragm or cervical cap with spermicide

- Intrauterine device (IUD)

- Hormonal birth control drugs given by pills, shots, or placed on or under the skin

- Tubal ligation

- NuvaRing

- Potential participant must have adequate organ function as indicated by the following
laboratory values:

System/Laboratory Value:

Hematological:

Absolute neutrophil count (ANC): ≥1,500/mcL Platelets: ≥125,000/mcL Hemoglobin: ≥12g/dL

Coagulation:

Prothrombin Time or INR: ≤1.5x upper limit of normal (ULN)

Chemistry:

K+ levels: Within normal limits Mg++levels: ≥1.2 mEq/L but <1.5 x ULN Glucose: Screening
serum glucose (fasting or non-fasting) <120 mg/dl Albumin: ≥3.3 g/dL

Renal:

Serum creatinine or calculated creatinine clearance: ≤1.5 x upper limit of normal (ULN) OR
≥ 60mL/min for potential participants with creatinine levels > 1.3 x institutional ULN

Hepatic:

Serum total bilirubin: Total bilirubin <1.8 times the upper limit of the normal range,
unless history of Gilbert's disease or deemed related to treatment with atazanavir. If
total bilirubin is elevated, direct bilirubin must be <2 times the ULN range.

AST (SGOT) and ALT (SGPT): ≤ 2.5 X ULN Alkaline Phosphatase: ≤ 2.5 X ULN NOTE: Creatinine
clearance should be calculated per institutional standard.

Exclusion Criteria

- HIV-2 antibody positive in the absence of a positive HIV-1 Western Blot as measured
at the Screening Visit (Visit 1).

- Untreated syphilis infection (defined as a positive rapid plasma reagin (RPR) without
clear documentation of treatment).

- Received any infusion blood product, immune globulin, or hematopoetic growth factors
within 90 days prior to study entry.

- History of lymph node irradiation or dissection.

- Use of any of the following within 90 days prior to entry: immunomodulatory,
cytokine, or growth stimulating factors such as systemic corticosteroids,
cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, IFN, interleukins,
interleukin-2 (IL-2), hydroxyurea, thalidomide, sargramostim (granulocyte
macrophage-colony stimulating factor [GM-CSF]), dinitrochlorobenzene (DNCB), thymosin
alpha, thymopentin, inosiplex, polyribonucleotide, or ditiocarb sodium, coumadin,
warfarin, or other Coumadin derivative anticoagulants.

- Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before
screening (Visit 1).

- Prior participation in AGS-004 clinical research study.

- Treatment interruption of ART for > 1 month since starting the ART from which pre-ART
plasma sample was drawn

- For any serious illness requiring systemic treatment or hospitalization, the
participant must either complete therapy or be clinically stable on therapy, in the
opinion of the site investigator, for at least 90 days prior to entry.

- Pregnancy or breastfeeding

- Any active malignancy that may require chemotherapy or radiation therapy.

- Evidence of hepatic decompensation in cirrhotic participants: history of ascites,
hepatic encephalopathy, or bleeding esophageal varices.

- History or other clinical evidence of significant or unstable cardiac disease (e.g.,
angina, congestive heart failure, recent myocardial infarction, significant
arrhythmia) or clinically significant electrocardiogram (ECG) abnormalities. Any
history of cardiac rhythm disturbance requiring medical or surgical therapy.

- Any renal disorder deemed clinically significant by the investigator.

- History or other evidence of severe illness, malignancy, immunodeficiency other than
HIV, or any other condition that would make the participant unsuitable for the study
in the opinion of the investigator.

- Compulsorily detained (involuntarily incarcerated) for treatment of either a
psychiatric illness or a physical illness, e.g., infectious disease. Prisoner
recruitment and participation is not permitted.

- Known allergy or sensitivity to the components of the investigational immunotherapy.

- Use of systemic corticosteroids and use of topical steroids over a total area
exceeding 15 cm2 within 30 days prior to Screening or anticipated need for periodic
use of corticosteroids during the study.

NOTE: For participants receiving ritonavir (as a booster or protease inhibitor (PI) as
part of their ART regimen, the concomitant use of oral/systemic/topical/inhaled/intranasal
corticosteroids is prohibited.

- Any history of acute or chronic pancreatitis.

- If the HIV care provider or study investigator is unable, as assessed by the study PI
or protocol team, to construct a fully active alternative ART regimen based on
previous resistance testing and/or treatment history.

- Known psychiatric or substance abuse disorders that would interfere with one's
ability to fully cooperate with the requirements of the trial.

- Any investigational antiretroviral agents or use of a CCR5 inhibitor at Screening.

- Active autoimmune disease or condition including, but not limited to:

- Rheumatoid arthritis (RF positive arthritis with current or recent flare);

- Inflammatory bowel disease;

- Systemic lupus erythematosis (clinical evidence confirmed with ANA >1:80);

- Ankylosing spondylitis; Hashimoto's disease; Scleroderma; Multiple sclerosis;
Autoimmune hemolytic anemia (AHA); Immune thrombocytopenic purpura; and, Type I
diabetes mellitus (insulin therapy for Type II diabetes is permitted).

- Participation in another investigational clinical research study (with the exception
of an antiretroviral treatment trial that uses FDA approved antiretroviral agents) or
use of investigational agents within 30 days prior to Screening.