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

NCT00918840 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2013-02-08

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infection

Interventions

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

BIOLOGICAL

Placebo

Dextrose/glucose solution

DRUG

HAART

Three or more antiretroviral drugs that can fully suppress HIV RNA

Sponsors & Collaborators

  • ViroStatics srl

    collaborator INDUSTRY

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    collaborator OTHER

  • Genetic Immunity

    lead INDUSTRY

Principal Investigators

  • Renato Maserati, MD · Fondazione IRCCS Policlinico San Matteo di Pavia

  • Franco Lori, MD · ViroStatics srl

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00918840 on ClinicalTrials.gov