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Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV

NCT00659789 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2017-02-23

Study results available
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Summary

Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Conditions

  • HIV I Infection

Interventions

DRUG

Vacc-4x

Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

DRUG

Sterile water

Sterile water is used in place of Vacc-4x and in place of Leukine

Sponsors & Collaborators

  • Bionor Immuno AS

    lead INDUSTRY

Principal Investigators

  • Richard Pollard, MD · University of California at Davis, USA

  • Jürgen Rochstroh, MD · Universitätsklinikum Bonn, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-06-30
Completion
2011-06-30

Countries

  • United States
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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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 NCT00659789 on ClinicalTrials.gov