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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
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.
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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
UCLA CARE Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of Miami School of Medicine
Miami, Florida, United States
Northwestern University Division of Infectious Diseases
Chicago, Illinois, United States
EPIMED GmbH
Berlin, State of Berlin, Germany
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Klinik I für Innere Medizin Klinikum Der Universität zu Köln
Cologne, Germany
ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
Hamburg, Germany
Start Date
August 1, 2008
Primary Completion Date
June 1, 2010
Completion Date
June 1, 2011
Last Updated
February 23, 2017
137
ACTUAL participants
Vacc-4x
DRUG
Sterile water
DRUG
Lead Sponsor
Bionor Immuno AS
NCT05947890
NCT06834113
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05590455