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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Biological: DermaVir
Biological: Placebo
Drug: HAART
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genetic Immunity:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

peripheral blood mononuclear cells (PBMC) and plasma


Enrollment: 16
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
Drug: HAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Other Name: Highly active antiretroviral therapy
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
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

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918840

Locations
Italy
IRCCS Policlinico S. Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
Genetic Immunity
ViroStatics srl
IRCCS Policlinico S. Matteo
Investigators
Principal Investigator: Renato Maserati, MD IRCCS Policlinico S. Matteo
Study Chair: Franco Lori, MD ViroStatics srl
  More Information

Additional Information:
Publications:

Responsible Party: Genetic Immunity
ClinicalTrials.gov Identifier: NCT00918840     History of Changes
Other Study ID Numbers: PHPC-02, 2008-003765-11
Study First Received: June 8, 2009
Last Updated: February 7, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Genetic Immunity:
HIV
Vaccine
Immune Therapy
DermaVir
Treatment experienced

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 April 16, 2014