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

Sponsor:	Bionor Immuno AS
Information provided by:	Bionor Immuno AS
ClinicalTrials.gov Identifier:	NCT00659789

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Vacc-4x Drug: Sterile water	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Drinking Water

U.S. FDA Resources

Further study details as provided by Bionor Immuno AS:

Primary Outcome Measures:

To evaluate the proportion of subjects who require resumption of ART between the interruption of ART at week 28 and end of study at week 52. To evaluate the % change in CD4 between week 28 and the last CD4 made prior to resumption of ART or week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and tolerability of Vacc-4x [ Time Frame: Several points throughout the study ] [ Designated as safety issue: Yes ]
Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) [ Time Frame: Several points throughout the study ] [ Designated as safety issue: Yes ]
Effect of Vacc-4x on CD8 counts and HIV viral RNA [ Time Frame: Several points throughout the study ] [ Designated as safety issue: Yes ]
Time to restart of ART for Vacc-4x subjects versus placebo [ Time Frame: Several points throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Vacc-4x immunization	Drug: Vacc-4x Vacc-4x is a peptide-based HIV immunotherapy administered intradermally
B: Placebo Comparator Placebo	Drug: Sterile water Sterile water for injection.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659789

Locations

United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-8700
UCLA CARE Center
Los Angeles, California, United States, 90035
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University Division of Infectious Diseases
Chicago, Illinois, United States, 60611
Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Universitätsklinikum Bonn
Bonn, Germany, 53127
Klinik I für Innere Medizin Klinikum Der Universität zu Köln
Köln, Germany, 50937
ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
Hamburg, Germany, 20099
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
EPIMED GmbH
Berlin, Germany, 12157
Italy
Istituto San Raffaele
Milano, Italy
Spain
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.
Barcelona, Spain, 08907
United Kingdom
Harrison Wing St Thomas' Hospital
London, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre
Brighton, United Kingdom, BN2 1EE

Sponsors and Collaborators

Bionor Immuno AS

More Information

No publications provided

Responsible Party:	Bionor Immuno AS ( Bionor Immuno AS )
Study ID Numbers:	CT-BI Vacc-4x 2007/1, EudraCT No.: 2007-006302-13
Study First Received:	April 14, 2008
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00659789 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; Germany: Paul-Ehrlich-Institut; Germany: Ethics Commission; Italy: Ethics Committee; Spain: Spanish Agency of Medicines; Spain: Ethics Committee

Keywords provided by Bionor Immuno AS:

treatment experienced

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 20, 2009