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

January 27, 2020 updated by: Genetic Immunity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20146
        • ICH Grindel
      • Hamburg, Germany, 20099
        • ifi-Medizin GmbH at the Asklepios Klinik St. Georg
      • Hamburg, Germany, 20249
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV-1 RNA
Time Frame: 24 weeks
24 weeks
CD4+ and CD8+ T-cell counts
Time Frame: 24 weeks
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)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genetic Immunity

Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Jan Van Lunzen, PhD, MD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 4, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DermaVir Phase II
  • 2007-001955-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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