Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Genetic Immunity

Collaborator
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
History of Changes
Purpose

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
HIV Infection

Biological : DermaVir
Biological : Placebo
Drug : HAART

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

Further study details as provided by Genetic Immunity:

Primary Outcome Measures

  • HIV-specific memory T cells measured as PHPC count [ Time Frame: 9 week ]
    DermaVir-induced PHPC count compared to Placebo
Secondary Outcome Measures:
  • 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 ]

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)

Arms 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
ubject becomes pregnant

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 55 Years  
Sexes Eligible for Study: All  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information

Additional Information:

Genetic Immunity's homepage

Additional Information:

Virostatics srl homepage

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  

Keywords provided by Genetic Immunity:

HIV
Vaccine
Immune Therapy
DermaVir
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Anti-Retroviral Agents

ClinicalTrials.gov processed this data on May 20, 2019
This information is provided by ClinicalTrials.gov.