Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients (GIEU006)

Genetic Immunity

Status and phase: Completed; Phase 2

Conditions: HIV Infection

Treatments: Biological: Placebo; Biological: DermaVir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00711230

DermaVir Phase II

2007-001955-20 (EudraCT Number)

Details and patient eligibility

About

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells.

GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.

Full description

Patients were randomized into one of the following 6 arms:

• Arm 1: Low dose DermaVir (0.2 mg DNA in 2 DermaPrep patches, n=9)
• Arm 2: Low dose Placebo (2 DermaPrep patches, n=3)
• Arm 3: Medium dose DermaVir (0.4 mg DNA in 4 DermaPrep patches, n=9)
• Arm 4: Medium dose Placebo (4 DermaPrep patches, n=3)
• Arm 5: High dose DermaVir (0.8 mg DNA in 8 DermaPrep patches, n=9)
• Arm 6: High dose Placebo (8 DermaPrep patches, n=3) DermaPrep Patch size: 80 cm2. DermaVir Standard Unit per patch is 0.1 mg DNA = 0.8 mL of DermaVir nanomedicine.

The patch sites for immunization are preferably the left or right upper back and left or right upper ventral thigh. The same skin sites should be used for all immunizations.

Immunization schedule (Days): 0, 42, 84, and 126.

The total DermaVir dose:

• Low dose: 0.8 mg DNA
• Medium dose: 1.6 mg DNA
• High Dose: 3.2 mg DNA

DermaVir immunizations were administered over an 18-week period Primary endpoint: 24 weeks Safety follow up: 234 weeks

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion Criteria:

• HIV antibody positive
• Plasma HIV RNA value ≥5,000 copies/mL and ≤ 150,000 c/mL
• Antiretroviral therapy naïve
• Documented CD4+ T-cell count at screening ≥400 cells/mm3

Main exclusion Criteria:

• No skin disease
• No tattoos, or changes in pigmentation at the selected skin immunization sites
• No acute or chronic illness (e.g Hepatitis C)
• No chronic autoimmune diseases
• No treatment with any immune modulating agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 6 patient groups

1: Low dose DermaVir

Experimental group

Description:

* Dosage: 0.2 mg DNA * Dosage form: 1.6 mL DNA/PEIm nanomedicine * Administration with 2 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)

Treatment:

Biological: DermaVir

2: Low dose Placebo

Experimental group

Description:

* Dosage form: 1.6 mL Placebo * Administration with 2 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)

Treatment:

Biological: Placebo

3: Medium dose DermaVir

Experimental group

Description:

* Dosage: 0.4 mg DNA * Dosage form: 3.2 mL DNA/PEIm nanomedicine * Administration with 4 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)

Treatment:

Biological: DermaVir

4: Medium dose Placebo

Experimental group

Description:

* Dosage form: 1.6 mL Placebo * Administration with 4 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)

Treatment:

Biological: Placebo

5: High dose DermaVir

Experimental group

Description:

* Dosage: 0.8 mg DNA * Dosage form: 6.4 mL DNA/PEIm nanomedicine * Administration with 8 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 DermaVir treatments)

Treatment:

Biological: DermaVir

6: High dose Placebo

Experimental group

Description:

* Dosage form: 6.4 mL Placebo * Administration with 8 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments)

Treatment:

Biological: Placebo