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

This study is ongoing, but not recruiting participants.
Sponsor:
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

July 4, 2008
February 19, 2013
April 2008
December 2011   (final data collection date for primary outcome measure)
Percent of participants with primary safety endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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.
Safety and tolerability of DermaVir Patch [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00711230 on ClinicalTrials.gov Archive Site
  • HIV-1 RNA [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • CD4+ and CD8+ T-cell counts [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • HIV-specific memory T cell responses [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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)
  • HIV-1 RNA measurements to assess the antiretroviral activity of the DermaVir Patch [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Changes in CD4+ and CD8+ T-cell counts during DermaVir Patch treatment [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Immunogenicity of DermaVir Patch [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients
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

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infection
  • Biological: DermaVir
    Other Name: LC002
  • Biological: Placebo
    glucose/dextrose
    Other Name: Placebo
  • 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)
    Intervention: Biological: DermaVir
  • 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)
    Intervention: Biological: Placebo
  • 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)
    Intervention: Biological: DermaVir
  • 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)
    Intervention: Biological: Placebo
  • 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)
    Intervention: Biological: DermaVir
  • 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)
    Intervention: Biological: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
January 2015
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00711230
DermaVir Phase II, 2007-001955-20
Yes
Genetic Immunity
Genetic Immunity
Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Jan Van Lunzen, PhD, MD Universitätsklinikum Hamburg-Eppendorf
Genetic Immunity
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP