Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified February 2013 by Genetic Immunity

Sponsor
Genetic Immunity

Collaborator
Universitätsklinikum Hamburg-Eppendorf

Information provided by (Responsible Party)
Genetic Immunity
ClinicalTrials.gov Identifier
NCT00711230

First received: July 4, 2008
Last updated: February 19, 2013
Last Verified: February 2013
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV Infection

Biological : DermaVir
Biological : Placebo
Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Genetic Immunity:

Primary Outcome Measures

  • 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:
  • 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)

Enrollment: 36
Study Start Date: April 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years to 50 Years  
    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

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: 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

    More Information

    Additional Information:

    Genetic Immunity's homepage

    Additional Information:

    DermaVir for initial treatment of HIV-infected subjects demonstrates preliminary safety, immunogenicity and HIV-RNA reduction versus placebo immunization

    Responsible Party: Genetic Immunity  
    ClinicalTrials.gov Identifier: NCT00711230   History of Changes  
    Other Study ID Numbers: DermaVir Phase II  
      2007-001955-20  
    Study First Received: July 4, 2008  
    Last Updated: February 19, 2013  

    Keywords provided by Genetic Immunity:

    HIV
    Vaccine
    Immune Therapy
    DermaVir

    Additional relevant MeSH terms:
    HIV Infections

    ClinicalTrials.gov processed this data on August 19, 2019
    This information is provided by ClinicalTrials.gov.