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

This study has been completed.
Sponsor:
Collaborators:
ViroStatics srl
IRCCS Policlinico S. Matteo
Information provided by (Responsible Party):
Genetic Immunity
ClinicalTrials.gov Identifier:
NCT00918840
First received: June 8, 2009
Last updated: February 7, 2013
Last verified: February 2013

June 8, 2009
February 7, 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 ] [ Designated as safety issue: No ]
DermaVir-induced PHPC count compared to Placebo
HIV specific PHPC counts [ Time Frame: At each visit, 14 times alltogether ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00918840 on ClinicalTrials.gov Archive Site
  • HIV-1 RNA [ Time Frame: weeks 16 and 20 ] [ Designated as safety issue: Yes ]
    HIV-1 RNA set-point after analytical treatment interruption
  • CD4+ and CD8+ T cell counts [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • HIV-1 RNA [ Time Frame: At each visit except for visit 5, 13 times ] [ Designated as safety issue: Yes ]
  • Immunogenicity of DermaVir Patch [ Time Frame: At each visit except for visit 5, 13 times ] [ Designated as safety issue: No ]
  • Safety and tolerability of DermaVir Patch [ Time Frame: At visit 2, 3, 4 and 5 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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)
    Interventions:
    • 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)
    Interventions:
    • Biological: Placebo
    • Drug: HAART

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00918840
PHPC-02, 2008-003765-11
Yes
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

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