Conditions: HIV Infection
Keywords: HIV Vaccine Immune Therapy DermaVir
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief 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).

Detailed description:
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.

Arms:
arm 1: Single low-dose DermaVir immunization

* 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
* Administered topically with DermaPrep under two skin patches (0.4 mL/patch) arm 2: Single medium-dose DermaVir immunization

* 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
* Administered topically with DermaPrep under four skin patches (0.8 mL/patch) arm 3: Single high-dose DermaVir immunization

* 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
* Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)

Interventions: intervention 1: DermaVir intervention 2: HAART
Intervention descriptions: intervention 1: 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. intervention 2: Three or more antiretroviral drugs that can fully suppress HIV RNA

Protocol document: