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

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ClinicalTrials.gov Identifier: NCT00711230
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Genetic Immunity

Tracking Information
First Submitted Date  ICMJE July 4, 2008
First Posted Date  ICMJE July 8, 2008
Last Update Posted Date January 28, 2020
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
Safety and tolerability of DermaVir Patch [ Time Frame: Throughout the study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2008)
  • HIV-1 RNA measurements to assess the antiretroviral activity of the DermaVir Patch [ Time Frame: Throughout the study ]
  • Changes in CD4+ and CD8+ T-cell counts during DermaVir Patch treatment [ Time Frame: Throughout the study ]
  • Immunogenicity of DermaVir Patch [ Time Frame: Throughout the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients
Official Title  ICMJE 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
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • Biological: DermaVir
    Other Name: LC002
  • Biological: Placebo
    glucose/dextrose
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2008)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2015
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00711230
Other Study ID Numbers  ICMJE DermaVir Phase II
2007-001955-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genetic Immunity
Study Sponsor  ICMJE Genetic Immunity
Collaborators  ICMJE Universitätsklinikum Hamburg-Eppendorf
Investigators  ICMJE
Principal Investigator: Jan Van Lunzen, PhD, MD Universitätsklinikum Hamburg-Eppendorf
PRS Account Genetic Immunity
Verification Date January 2020

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