Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients (GIEU006)
|ClinicalTrials.gov Identifier: NCT00711230|
Recruitment Status : Unknown
Verified February 2013 by Genetic Immunity.
Recruitment status was: Active, not recruiting
First Posted : July 8, 2008
Last Update Posted : February 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Biological: DermaVir Biological: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2008|
|Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||January 2015|
Experimental: 1: Low dose DermaVir
Other Name: LC002
Experimental: 2: Low dose Placebo
Experimental: 3: Medium dose DermaVir
Other Name: LC002
Experimental: 4: Medium dose Placebo
Experimental: 5: High dose DermaVir
Other Name: LC002
Experimental: 6: High dose Placebo
- Percent of participants with primary safety endpoint [ Time Frame: 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.
- HIV-1 RNA [ Time Frame: 24 weeks ]
- CD4+ and CD8+ T-cell counts [ Time Frame: 24 weeks ]
- HIV-specific memory T cell responses [ Time Frame: 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711230
|ifi-Medizin GmbH at the Asklepios Klinik St. Georg|
|Hamburg, Germany, 20099|
|Hamburg, Germany, 20146|
|University Medical Center Hamburg-Eppendorf|
|Hamburg, Germany, 20249|
|Principal Investigator:||Jan Van Lunzen, PhD, MD||Universitätsklinikum Hamburg-Eppendorf|