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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
HIV Infection Biological: DermaVir Biological: Placebo Phase 2

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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)
Biological: DermaVir
Other Name: LC002
Experimental: 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)
Biological: Placebo
glucose/dextrose
Experimental: 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)
Biological: DermaVir
Other Name: LC002
Experimental: 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)
Biological: Placebo
glucose/dextrose
Experimental: 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)
Biological: DermaVir
Other Name: LC002
Experimental: 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)
Biological: Placebo
glucose/dextrose


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. HIV-1 RNA [ Time Frame: 24 weeks ]
  2. CD4+ and CD8+ T-cell counts [ Time Frame: 24 weeks ]
  3. 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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711230


Locations
Germany
ifi-Medizin GmbH at the Asklepios Klinik St. Georg
Hamburg, Germany, 20099
ICH Grindel
Hamburg, Germany, 20146
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20249
Sponsors and Collaborators
Genetic Immunity
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Jan Van Lunzen, PhD, MD Universitätsklinikum Hamburg-Eppendorf
More Information

Additional Information:
Publications:

Responsible Party: Genetic Immunity
ClinicalTrials.gov Identifier: NCT00711230     History of Changes
Other Study ID Numbers: DermaVir Phase II
2007-001955-20 ( EudraCT Number )
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Genetic Immunity:
HIV
Vaccine
Immune Therapy
DermaVir

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases