Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients
- Conditions
- HIV Infection
- Interventions
- Biological: DermaVirBiological: Placebo
- Registration Number
- NCT00711230
- Lead Sponsor
- Genetic Immunity
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3: Medium dose DermaVir DermaVir * 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) 6: High dose Placebo Placebo * Dosage form: 6.4 mL Placebo * Administration with 8 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments) 2: Low dose Placebo Placebo * Dosage form: 1.6 mL Placebo * Administration with 2 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments) 4: Medium dose Placebo Placebo * Dosage form: 1.6 mL Placebo * Administration with 4 DermaPrep patches * Frequency: every six weeks * Duration: 18 weeks (4 Placebo treatments) 5: High dose DermaVir DermaVir * 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) 1: Low dose DermaVir DermaVir * 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)
- Primary Outcome Measures
Name Time Method Percent of participants with primary safety endpoint 24 weeks Primary safety endpoint: occurrence of at least two \> Grade 3 adverse event including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment (as judged by the GIEU006 team, including site clinicians on the team, blinded to treatment arm) any time from the first day of study treatment until 42 days after the last study vaccine administration.
- Secondary Outcome Measures
Name Time Method HIV-1 RNA 24 weeks CD4+ and CD8+ T-cell counts 24 weeks HIV-specific memory T cell responses 24 weeks Measured with Precursors with High Proliferative Capacity (PHPC) assay (Calarota et al. HIV-1-Specific T cell precursors with high proliferative capacity correlate with low viremia and high CD4 counts in untreated individuals. J Immunol 2008;180:5907-15)
Trial Locations
- Locations (3)
ifi-Medizin GmbH at the Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
ICH Grindel
🇩🇪Hamburg, Germany
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany