Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)

Inclusion Criteria

• ≥ 18 years and or equal to 50 copies/mL on two consecutive time points in the last 24 months.

NOTE: A single unconfirmed plasma HIV RNA > or equal to 50 copies/mL but 60 mL/min Hepatic Serum total bilirubin Total bilirubin < 1.1 times the ULN range. If total bilirubin is elevated, direct bilirubin must be < 2 times the ULN range.

NOTE: If participant is on an atazanavir-containing therapy, then a direct bilirubin should be measured instead of the total bilirubin and must be ≤ 1.0 mg/dL.

Aspartate Aminotransferase (AST) (SGOT) and Alanine Transaminase (ALT) (SGPT) < 1.25 X ULN Alkaline Phosphatase < 1.25 X ULN Lipase < 1.1 X ULN

Footnote 1: LLN for Mg++ per the clinical laboratory's normal range used for this study is a grade 1 event per Division of AIDS (DAIDS) Toxicity Table and is allowed for eligibility

ULN = upper limit of normal LLN = lower limit of normal WNL = within normal limits

Exclusion Criteria

• Known allergy or sensitivity to components of VOR and its analog or to components in the HXTC product.
• Women without written documentation of menopause (absence of a period for ≥ one year and FSH level indicating menopause), hysterectomy or bilateral oophorectomy, non-surgical permanent sterilization, or bilateral tubal ligation.
• Untreated syphilis infection (defined as a positive rapid plasma reagin (RPR) without clear documentation of treatment).

Note: In cases of untreated syphilis, participant may re-screen following documentation of adequate treatment of syphilis

• All male participants expecting to father children within the projected duration of the study.
• Receipt of compounds with Histone Deacetylase (HDAC) inhibitor-like activity, such as valproic acid within 30 days prior to screening.
• Use of any investigational antiretroviral agents within 30 days prior to screening.
• If the study PI (or designee) is unable to construct a fully active alternative cART regimen based on previous resistance testing and/or treatment history.
• Use of the following medications that carry risk of torsade des pointes: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine.
• Use of any of the following within 90 days prior to screening: immunomodulatory, cytokine, or growth stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, interferon (IFN), interleukin-2 (IL-2), coumadin, warfarin, or other Coumadin derivative anticoagulants.
• Prior use of any HIV immunotherapy or HIV vaccine within 6 months prior to Screening, except for prior HXTC infusions.
• Received any infusion blood product, immune globulin, or hematopoietic growth factors within 90 days prior to study screening.
• Pregnancy or breast-feeding.
• History or other clinical 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 (or designee).
• Use of topical steroids over a total area exceeding 15 cm-2 within 30 days prior to Screening.
• Treatment for an active AIDS-defining opportunistic infection within 90 days prior to Screening.
• Any active malignancy that may require chemotherapy or radiation therapy.
• 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 psychiatric or substance abuse disorders that would interfere with participant's ability to fully cooperate with the requirements of the trial as assessed by the study investigator (or designee).
• History