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

February 7, 2013 updated by: Genetic Immunity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • IRCCS Policlinico S. Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Drug: HAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Other Names:
  • Highly active antiretroviral therapy
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 Names:
  • LC002
Placebo + HAART
  • Dosage form: 3.2 mL Placebo
  • Administration with 4 DermaPrep patches
  • Frequency: every four weeks
  • Duration: 8 weeks (3 Placebo treatments)
Drug: HAART
Three or more antiretroviral drugs that can fully suppress HIV RNA
Other Names:
  • Highly active antiretroviral therapy
Biological: Placebo
Dextrose/glucose solution
Other Names:
  • LC002 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV-specific memory T cells measured as PHPC count
Time Frame: 9 week
DermaVir-induced PHPC count compared to Placebo
9 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV-1 RNA
Time Frame: weeks 16 and 20
HIV-1 RNA set-point after analytical treatment interruption
weeks 16 and 20
CD4+ and CD8+ T cell counts
Time Frame: 20 weeks
20 weeks
Adverse Events
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genetic Immunity

Collaborators

IRCCS Policlinico S. Matteo
ViroStatics srl

Investigators

  • Principal Investigator: Renato Maserati, MD, IRCCS Policlinico S. Matteo
  • Study Chair: Franco Lori, MD, ViroStatics srl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (ESTIMATE)

June 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHPC-02
  • 2008-003765-11 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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