Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Completed · Phase 2 · Has a placebo group
Conditions studied: HIV I Infection
In brief
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.
Key facts
- Study ID
- NCT00659789
- Run by
- Bionor Immuno AS
- People needed
- 137
- Starts
- 2008-08-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2017-02-23
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Universitätsklinikum Hamburg Eppendorf — Hamburg, Germany
- Istituto San Raffaele — Milan, Italy
- Hospital Germans Trias i Pujol — Badalona, Spain
- Hospital Clinic i Provincial — Barcelona, Spain
- Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat. — Barcelona, Spain
- Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre — Brighton, United Kingdom
- Chelsea and Westminster Hospital — London, United Kingdom
- Harrison Wing St Thomas' Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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