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Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients

NCT00711230 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-01-28

No results posted yet for this study

Summary

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells.

GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.

Conditions

  • HIV Infection

Interventions

BIOLOGICAL

DermaVir

BIOLOGICAL

Placebo

glucose/dextrose

Sponsors & Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • Genetic Immunity

    lead INDUSTRY

Principal Investigators

  • Jan Van Lunzen, PhD, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-12-31
Completion
2015-01-01

Countries

  • Germany

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 NCT00711230 on ClinicalTrials.gov