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Single DermaVir Immunization in HIV-1 Infected Patients on HAART (GIHU004)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00712530
Recruitment Status : Completed
First Posted : July 10, 2008
Results First Posted : March 26, 2013
Last Update Posted : March 26, 2013
Sponsor:
Information provided by (Responsible Party):
Genetic Immunity

Study Description
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Brief Summary:
  • DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells.
  • Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction of HIV-specific precursor/memory T cell responses.
  • GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the safety and immunogenicity of three dosing regimens of topical DermaVir immunization for the treatment of HIV-infected individuals on fully suppressive highly active antiretroviral therapy (HAART).

Condition or disease Intervention/treatment Phase
HIV Infection Biological: DermaVir Drug: HAART Phase 1

Detailed Description:

This study enrolled nine HIV-infected adult subjects in three sequential dose cohorts. All had durable suppression of HIV-RNA on HAART over the previous 6 months and CD4 count over 300 cells/mm3. Subjects, received on study Day 0 a single DermaVir immunization:

  • Low dose: 0.1 mg pDNA, 0.8 mL DermaVir administered under two DermaPrep patches.
  • Medium dose: 0.4 mg pDNA, 3.2 mL DermaVir administered under four DermaPrep patches.
  • High dose: 0.8 mg pDNA, 6.4 mL DermaVir administered under eight DermaPrep patches.

Subjects were on study for a total of 28 days followed by a post-treatment safety follow-up for 48 weeks. HAART was not interrupted. All subjects completed the 28-day treatment and 48 weeks safety follow up phase.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Tolerability and Safety of LC002, a DermaVir Vaccine, in HIV-1-infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)
Study Start Date : January 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1

Single low-dose DermaVir immunization

  • 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir
  • Administered topically with DermaPrep under two skin patches (0.4 mL/patch)
 Biological: DermaVir
DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells.
Other Name: LC002

Drug: HAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Other Name: Highly active antiretroviral therapy
Experimental: 2

Single medium-dose DermaVir immunization

  • 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir
  • Administered topically with DermaPrep under four skin patches (0.8 mL/patch)
 Biological: DermaVir
DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells.
Other Name: LC002

Drug: HAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Other Name: Highly active antiretroviral therapy
Experimental: 3

Single high-dose DermaVir immunization

  • 0.8 mg pDNA/subject, 6.4 mL total volume of DermaVir
  • Administered topically with DermaPrep under eight skin patches (0.4 mL/patch)
 Biological: DermaVir
DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells.
Other Name: LC002

Drug: HAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Other Name: Highly active antiretroviral therapy


Outcome Measures
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Primary Outcome Measures :
  1. Grade 3 Adverse Event Related to DermaVir Treatment [ Time Frame: 28 days ]
    Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.


Secondary Outcome Measures :
  1. CD4+ T Cell Counts/mm3 [ Time Frame: 28 days ]
  2. Number of Subjects With Detectable Anti-ds Antibody and ANA [ Time Frame: 28 days ]
  3. Number of Subjects Having More Than 50 Copies/mL HIV RNA [ Time Frame: 28 days ]
  4. Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline [ Time Frame: 28 days ]
    HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.


Other Outcome Measures:
  1. Change in HIV-specific Memory T Cell Responses at Week 48 [ Time Frame: 48 weeks ]

    HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.

    Note, group Single low-dose was measured at 24 weeks, for this group the 48 weeks data is not available



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability and willingness of subject or legal guardian/representative to give written informed consent
  • HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA
  • On a stable antiretroviral regimen without changes or interruptions for at least 12 weeks prior to study entry
  • Plasma HIV-1 RNA level of less than 50 copies/mL, obtained at least twice within the 12 weeks prior to study entry
  • Peak plasma HIV-1 RNA level before initiation of HAART > 1000 copies/mL
  • CD4 cell count > 300 cells/mm3 within the 12 weeks prior to study entry
  • Nadir (lowest) CD4+ cell count > 250 cells/mm3 at any time prior to study entry

  • The following laboratory values, obtained within 30 days prior to study entry:

    • Absolute neutrophil count (ANC) > 1000/mm3
    • Hemoglobin > 9.0 g/dL
    • Platelet count > 50,000/mm3
    • Serum creatinine < upper limit of the laboratory normal range (ULN)
    • AST (SGOT), ALT (SGPT), and alkaline phosphatase < 2.5 x ULN
    • Total bilirubin < 2.5 x ULN
    • Anti-nuclear antibody (ANA) titer of 1:40 or lower and negative for serum anti-double-stranded DNA antibody (anti-ds-DNA) test result at screening.
  • All women of reproductive potential must have a negative urine beta-HCG pregnancy test performed within 14 days prior to study entry.
  • Female study volunteers who are not of reproductive potential or whose male partner has undergone successful vasectomy are eligible without requiring the use of contraception. Acceptable documentation of menopause, sterilization, and azoospermia is written or oral documentation communicated by clinician.
  • All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and, if participating in sexual activity that could lead to pregnancy, the study volunteer/ partner must use two reliable methods of contraception simultaneously while receiving the protocol-specified vaccination and for 3 months after the last vaccination.
  • Karnofsky performance score > 90 within 30 days prior to study entry
  • Men and women age 18-50 years

Exclusion Criteria:

  • Viral load measurement > 50 copies/mL within the last 12 weeks prior to study entry
  • History of or evidence of active skin disease (e.g. atopic dermatitis), chronic autoimmune disease or any other significant active skin disease
  • Treatment with topical corticosteroids in close proximity to the proposed vaccination sites within 2 weeks prior to study entry
  • Excessive exposure to the sun (e.g. sunbathing) within 2 weeks prior to study entry
  • Use of any local skin treatments to the targeted vaccination sites within 7 days prior to study entry
  • History of diabetes and bleeding disorders
  • Previous CDC category C event
  • Pregnancy or breast-feeding
  • Use of immunomodulating therapy, including cyclosporin, IgG-containing products, interleukins, interferons, systemic glucocorticosteroids, or exposure to an experimental HIV vaccine within 6 months prior to study entry
  • Receipt of any vaccine within 30 days prior to study entry
  • Allergy/sensitivity to study vaccine products, including adhesives, will be excluded
  • Active drug or alcohol use or dependence
  • Serious illness until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry
  • Hepatitis B surface antigen and/or anti-hepatitis C positive
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712530


Locations
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Hungary
Saint Laszlo Hospital
Budapest, Hungary, 1097
Sponsors and Collaborators
Genetic Immunity
Investigators
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Principal Investigator: Denes Banhegyi, MD Saint Laszlo Hospital
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Genetic Immunity
ClinicalTrials.gov Identifier: NCT00712530    
Other Study ID Numbers: GIHU004
First Posted: July 10, 2008    Key Record Dates
Results First Posted: March 26, 2013
Last Update Posted: March 26, 2013
Last Verified: February 2013
Keywords provided by Genetic Immunity:
HIV
Vaccine
Immune Therapy
DermaVir
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents