NCT00659789

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

A Phase II, Randomized, Double-blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV-1 Who Have Maintained an Adequate Response to ART

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Bionor Immuno AS · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-06-01
• Completion: 2011-06-01
• First posted: 2008-04-16
• Last updated: 2017-02-23
• Results posted: 2017-01-05

Locations

18 sites across 5 countries: United States, Germany, Italy, Spain, United Kingdom