Single DermaVir Immunization in HIV-1 Infected Patients on HAART
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: DermaVir; HAART
Intervention description: DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells.; Three or more antiretroviral drugs that can fully suppress HIV RNA
Intervention MeSH terms: Anti-Retroviral Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: HIV; Vaccine; Immune Therapy; DermaVir

Summary:

      -  DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered
           topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir
           migrate to lymph nodes and express HIV-like particles that induce immune responses to
           kill HIV-infected cells.

        -  Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction
           of HIV-specific precursor/memory T cell responses.

        -  GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the
           safety and immunogenicity of three dosing regimens of topical DermaVir immunization for
           the treatment of HIV-infected individuals on fully suppressive highly active
           antiretroviral therapy (HAART).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and willingness of subject or legal guardian/representative to give written
             informed consent

          -  HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western
             blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a
             method other than ELISA

          -  On a stable antiretroviral regimen without changes or interruptions for at least 12
             weeks prior to study entry

          -  Plasma HIV-1 RNA level of less than 50 copies/mL, obtained at least twice within the
             12 weeks prior to study entry

          -  Peak plasma HIV-1 RNA level before initiation of HAART > 1000 copies/mL

          -  CD4 cell count > 300 cells/mm3 within the 12 weeks prior to study entry

          -  Nadir (lowest) CD4+ cell count > 250 cells/mm3 at any time prior to study entry

          -  The following laboratory values, obtained within 30 days prior to study entry:

               -  Absolute neutrophil count (ANC) > 1000/mm3

               -  Hemoglobin > 9.0 g/dL

               -  Platelet count > 50,000/mm3

               -  Serum creatinine < upper limit of the laboratory normal range (ULN)

               -  AST (SGOT), ALT (SGPT), and alkaline phosphatase < 2.5 x ULN

               -  Total bilirubin < 2.5 x ULN

               -  Anti-nuclear antibody (ANA) titer of 1:40 or lower and negative for serum
                  anti-double-stranded DNA antibody (anti-ds-DNA) test result at screening.

          -  All women of reproductive potential must have a negative urine beta-HCG pregnancy test
             performed within 14 days prior to study entry.

          -  Female study volunteers who are not of reproductive potential or whose male partner
             has undergone successful vasectomy are eligible without requiring the use of
             contraception. Acceptable documentation of menopause, sterilization, and azoospermia
             is written or oral documentation communicated by clinician.

          -  All subjects must not participate in a conception process (e.g. active attempt to
             become pregnant or to impregnate, sperm donation, in vitro fertilization) and, if
             participating in sexual activity that could lead to pregnancy, the study volunteer/
             partner must use two reliable methods of contraception simultaneously while receiving
             the protocol-specified vaccination and for 3 months after the last vaccination.

          -  Karnofsky performance score > 90 within 30 days prior to study entry

          -  Men and women age 18-50 years

        Exclusion Criteria:

          -  Viral load measurement > 50 copies/mL within the last 12 weeks prior to study entry

          -  History of or evidence of active skin disease (e.g. atopic dermatitis), chronic
             autoimmune disease or any other significant active skin disease

          -  Treatment with topical corticosteroids in close proximity to the proposed vaccination
             sites within 2 weeks prior to study entry

          -  Excessive exposure to the sun (e.g. sunbathing) within 2 weeks prior to study entry

          -  Use of any local skin treatments to the targeted vaccination sites within 7 days prior
             to study entry

          -  History of diabetes and bleeding disorders

          -  Previous CDC category C event

          -  Pregnancy or breast-feeding

          -  Use of immunomodulating therapy, including cyclosporin, IgG-containing products,
             interleukins, interferons, systemic glucocorticosteroids, or exposure to an
             experimental HIV vaccine within 6 months prior to study entry

          -  Receipt of any vaccine within 30 days prior to study entry

          -  Allergy/sensitivity to study vaccine products, including adhesives, will be excluded

          -  Active drug or alcohol use or dependence

          -  Serious illness until subject either completes therapy or is clinically stable on
             therapy, in the opinion of the site investigator, for at least 14 days prior to study
             entry

          -  Hepatitis B surface antigen and/or anti-hepatitis C positive