Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC) (PHPC-02)

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. Identifier: NCT00918840
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : February 8, 2013
ViroStatics srl
IRCCS Policlinico S. Matteo
Information provided by (Responsible Party):
Genetic Immunity

June 8, 2009
June 11, 2009
February 8, 2013
April 2009
June 2011   (Final data collection date for primary outcome measure)
HIV-specific memory T cells measured as PHPC count [ Time Frame: 9 week ]
DermaVir-induced PHPC count compared to Placebo
HIV specific PHPC counts [ Time Frame: At each visit, 14 times alltogether ]
Complete list of historical versions of study NCT00918840 on Archive Site
  • HIV-1 RNA [ Time Frame: weeks 16 and 20 ]
    HIV-1 RNA set-point after analytical treatment interruption
  • CD4+ and CD8+ T cell counts [ Time Frame: 20 weeks ]
  • Adverse Events [ Time Frame: 20 weeks ]
  • HIV-1 RNA [ Time Frame: At each visit except for visit 5, 13 times ]
  • Immunogenicity of DermaVir Patch [ Time Frame: At each visit except for visit 5, 13 times ]
  • Safety and tolerability of DermaVir Patch [ Time Frame: At visit 2, 3, 4 and 5 ]
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Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC)
Antiretroviral-Sparing Concept: An Exploratory Phase II, Randomized, Single Blind Placebo-Controlled Study to Investigate the Effect of Therapeutic Immunization on the Quantity of HIV-Specific T Cell Precursors During Highly Active Antiretroviral Therapy Followed by Analytical Treatment Interruption
PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load set point following analytical treatment interruption (ATI). Subjects will be randomized to receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects per cohort) every four weeks for three applications while receiving maximally suppressive HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.

16 subjects on maximally suppressive HAART were randomized to receive three doses of either DermaVir or Placebo immunotherapy.

Subjects receive three DermaVir/Placebo treatments over eight weeks (Weeks 0, 4 and 8) while receiving HAART. HAART is discontinued for a 20 week ATI.

Resumption of HAART during ATI is subjects experience:

  • A confirmed CD4+ cell decrease by > 50%
  • A confirmed CD4+ cell decrease to less than 350 counts/mL
  • A confirmed VL increase > 300,000 copies
  • Emergence of CDC AIDS related event(s)
  • Signs or symptoms of clinically significant immunosuppression
  • The subject or the subject's clinician wishes to restart HAART
  • The subject becomes pregnant
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
peripheral blood mononuclear cells (PBMC) and plasma
Probability Sample
Primary care clinic
HIV Infection
  • Biological: DermaVir
    DermaVir is a synthetic nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing 15 HIV proteins that assemble to HIV-like particles. DermaVir is topically administered with DermaPrep medical device to target the nanomedicine to Langerhans cells of the skin.These Langerhans cells migrate to the lymph node to induce cytotoxic T cells that can kill HIV-infected cells
    Other Name: LC002
  • Biological: Placebo
    Dextrose/glucose solution
    Other Name: LC002 Placebo
  • Drug: HAART
    Three or more antiretroviral drugs that can fully suppress HIV RNA
    Other Name: Highly active antiretroviral therapy
  • DermaVir + HAART
    • Dosage: 0.4 mg DNA
    • Dosage form: 3.2 mL DNA/PEIm nanomedicine
    • Administration with 4 DermaPrep patches
    • Frequency: every 4 weeks
    • Duration: 8 weeks (3 DermaVir treatments)
    • Biological: DermaVir
    • Drug: HAART
  • Placebo + HAART
    • Dosage form: 3.2 mL Placebo
    • Administration with 4 DermaPrep patches
    • Frequency: every four weeks
    • Duration: 8 weeks (3 Placebo treatments)
    • Biological: Placebo
    • Drug: HAART

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2011
June 2011   (Final data collection date for primary outcome measure)

Main inclusion Criteria:

  • HIV-1 infection
  • On a non-hydroxyurea based HAART for at least one year
  • Pre-HAART CD4 nadir > 250 cells/mm3
  • Pre-HAART viral load > 5,000 copies/mL
  • Undetectable viral load for the six month period preceding the study
  • CD4 T-cell count >500 cells/mm3 for the six month period preceding the study

Main exclusion Criteria:

  • No skin disease
  • No hypersensitivity to adhesive tape or Tegaderm
  • No history of keloid
  • No history of vitiligo, melasma, skin cancer
  • No tattoos or changes in pigment at the skin treatment sites
  • No autoimmune diseases
  • No hepatitis B, C coinfections
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
2008-003765-11 ( EudraCT Number )
Not Provided
Not Provided
Genetic Immunity
Genetic Immunity
  • ViroStatics srl
  • IRCCS Policlinico S. Matteo
Principal Investigator: Renato Maserati, MD IRCCS Policlinico S. Matteo
Study Chair: Franco Lori, MD ViroStatics srl
Genetic Immunity
February 2013