Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients
NCT ID: NCT00711230
Last Updated: 2020-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2008-04-30
2015-01-01
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1: Low dose 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)
DermaVir
2: Low dose Placebo
* Dosage form: 1.6 mL Placebo
* Administration with 2 DermaPrep patches
* Frequency: every six weeks
* Duration: 18 weeks (4 Placebo treatments)
Placebo
glucose/dextrose
3: Medium dose 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)
DermaVir
4: Medium dose Placebo
* Dosage form: 1.6 mL Placebo
* Administration with 4 DermaPrep patches
* Frequency: every six weeks
* Duration: 18 weeks (4 Placebo treatments)
Placebo
glucose/dextrose
5: High dose 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)
DermaVir
6: High dose Placebo
* Dosage form: 6.4 mL Placebo
* Administration with 8 DermaPrep patches
* Frequency: every six weeks
* Duration: 18 weeks (4 Placebo treatments)
Placebo
glucose/dextrose
Interventions
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DermaVir
Placebo
glucose/dextrose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Genetic Immunity
INDUSTRY
Responsible Party
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Principal Investigators
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Jan Van Lunzen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
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ifi-Medizin GmbH at the Asklepios Klinik St. Georg
Hamburg, , Germany
ICH Grindel
Hamburg, , Germany
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Countries
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References
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Lisziewicz J, Bakare N, Calarota SA, Banhegyi D, Szlavik J, Ujhelyi E, Toke ER, Molnar L, Lisziewicz Z, Autran B, Lori F. Single DermaVir immunization: dose-dependent expansion of precursor/memory T cells against all HIV antigens in HIV-1 infected individuals. PLoS One. 2012;7(5):e35416. doi: 10.1371/journal.pone.0035416. Epub 2012 May 9.
Lisziewicz J, Toke ER. Nanomedicine applications towards the cure of HIV. Nanomedicine. 2013 Jan;9(1):28-38. doi: 10.1016/j.nano.2012.05.012. Epub 2012 May 30.
Lorincz O, Toke ER, Somogyi E, Horkay F, Chandran PL, Douglas JF, Szebeni J, Lisziewicz J. Structure and biological activity of pathogen-like synthetic nanomedicines. Nanomedicine. 2012 May;8(4):497-506. doi: 10.1016/j.nano.2011.07.013. Epub 2011 Aug 10.
Toke ER, Lorincz O, Somogyi E, Lisziewicz J. Rational development of a stable liquid formulation for nanomedicine products. Int J Pharm. 2010 Jun 15;392(1-2):261-7. doi: 10.1016/j.ijpharm.2010.03.048. Epub 2010 Mar 25.
Lori F. DermaVir: a plasmid DNA-based nanomedicine therapeutic vaccine for the treatment of HIV/AIDS. Expert Rev Vaccines. 2011 Oct;10(10):1371-84. doi: 10.1586/erv.11.118.
Somogyi E, Xu J, Gudics A, Toth J, Kovacs AL, Lori F, Lisziewicz J. A plasmid DNA immunogen expressing fifteen protein antigens and complex virus-like particles (VLP+) mimicking naturally occurring HIV. Vaccine. 2011 Jan 17;29(4):744-53. doi: 10.1016/j.vaccine.2010.11.019. Epub 2010 Nov 23.
Calarota SA, Weiner DB, Lori F, Lisziewicz J. Induction of HIV-specific memory T-cell responses by topical DermaVir vaccine. Vaccine. 2007 Apr 20;25(16):3070-4. doi: 10.1016/j.vaccine.2007.01.024. Epub 2007 Jan 22.
Lisziewicz J, Trocio J, Whitman L, Varga G, Xu J, Bakare N, Erbacher P, Fox C, Woodward R, Markham P, Arya S, Behr JP, Lori F. DermaVir: a novel topical vaccine for HIV/AIDS. J Invest Dermatol. 2005 Jan;124(1):160-9. doi: 10.1111/j.0022-202X.2004.23535.x.
Lori F, Trocio J, Bakare N, Kelly LM, Lisziewicz J. DermaVir, a novel HIV immunisation technology. Vaccine. 2005 Mar 18;23(17-18):2030-4. doi: 10.1016/j.vaccine.2005.01.004.
Lisziewicz J, Trocio J, Xu J, Whitman L, Ryder A, Bakare N, Lewis MG, Wagner W, Pistorio A, Arya S, Lori F. Control of viral rebound through therapeutic immunization with DermaVir. AIDS. 2005 Jan 3;19(1):35-43. doi: 10.1097/00002030-200501030-00004.
Related Links
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Genetic Immunity's homepage
DermaVir for initial treatment of HIV-infected subjects demonstrates preliminary safety, immunogenicity and HIV-RNA reduction versus placebo immunization
Other Identifiers
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2007-001955-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DermaVir Phase II
Identifier Type: -
Identifier Source: org_study_id
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