Status:
COMPLETED
Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients
Lead Sponsor:
Genetic Immunity
Collaborating Sponsors:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
HIV Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 ar...
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 dos...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00711230
Start Date
April 1 2008
End Date
January 1 2015
Last Update
January 28 2020
Active Locations (3)
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1
ifi-Medizin GmbH at the Asklepios Klinik St. Georg
Hamburg, Germany, 20099
2
ICH Grindel
Hamburg, Germany, 20146
3
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20249