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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Genetic Immunity:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 36
Study Start Date: April 2008
Estimated Study Completion Date: January 2015
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
Other Name: 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)
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
Other Name: 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)
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
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20249
ICH Grindel
Hamburg, Germany, 20146
ifi-Medizin GmbH at the Asklepios Klinik St. Georg
Hamburg, Germany, 20099
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
Study First Received: July 4, 2008
Last Updated: February 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Genetic Immunity:
HIV
Vaccine
Immune Therapy
DermaVir

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

ClinicalTrials.gov processed this record on July 28, 2014