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

HIV Infection Clinical Trial

Official title:
A Phase II Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antiretroviral Activity of DermaVir Patch (LC002) in Treatment-Naïve HIV-1-Infected Patients

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00711230
Study type Interventional
Source Genetic Immunity
Contact
Status Completed
Phase Phase 2
Start date April 2008
Completion date January 1, 2015
View Details
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