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

Launched by BIONOR IMMUNO AS · Apr 15, 2008

Keywords

ClinConnect 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 immunother...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-55
• • HIV positive at least one year
• • Clinically stable on ART for at least six months
• • Documented viral load less than 50 copies/mL for the last six months
• • Documented prestudy CD4 cell count equal or more than 400x10exp6/L
• • Nadir CD4 cell count equal or more than 200x10exp6/L
• • Signed informed consent
• Exclusion Criteria:
• • Reported pre-study AIDS-defining illness within the previous year
• • Malignant disease
• • On chronic treatment with immuno-suppressive therapy
• • Unacceptable values of hematology and clinical chemistry parameters
• • Current chronic infection such as HCV and HBV or active tuberculosis
• • Pregnant or breastfeeding women
• • Not using safe contraceptive methods
• • Participation in other clinical trial
• • Incapability of compliance