* 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).
This study enrolled nine HIV-infected adult subjects in three sequential dose cohorts. All had durable suppression of HIV-RNA on HAART over the previous 6 months and CD4 count over 300 cells/mm3. Subjects, received on study Day 0 a single DermaVir immunization: * Low dose: 0.1 mg pDNA, 0.8 mL DermaVir administered under two DermaPrep patches. * Medium dose: 0.4 mg pDNA, 3.2 mL DermaVir administered under four DermaPrep patches. * High dose: 0.8 mg pDNA, 6.4 mL DermaVir administered under eight DermaPrep patches. Subjects were on study for a total of 28 days followed by a post-treatment safety follow-up for 48 weeks. HAART was not interrupted. All subjects completed the 28-day treatment and 48 weeks safety follow up phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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
Saint Laszlo Hospital
Budapest, Budapest, Hungary
Grade 3 Adverse Event Related to DermaVir Treatment
Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.
Time frame: 28 days
CD4+ T Cell Counts/mm3
Time frame: 28 days
Number of Subjects With Detectable Anti-ds Antibody and ANA
Time frame: 28 days
Number of Subjects Having More Than 50 Copies/mL HIV RNA
Time frame: 28 days
Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline
HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier \[Calarota et al. J Immunol 2008\]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.
Time frame: 28 days
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