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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bionor Immuno AS

ClinicalTrials.gov Identifier:

NCT00659789

First received: April 14, 2008

Last updated: February 2, 2012

Last verified: August 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	April 14, 2008
Last Updated Date	February 2, 2012
Start Date ^ICMJE	August 2008
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 13, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: April 15, 2008)	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. [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00659789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 15, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Official Title ^ICMJE	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
Brief 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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Vacc-4x Vacc-4x is a peptide-based HIV immunotherapy administered intradermally Drug: Sterile water Sterile water for injection.
Study Arm (s)	Experimental: A Vacc-4x immunization Intervention: Drug: Vacc-4x Placebo Comparator: B Placebo Intervention: Drug: Sterile water
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	137
Completion Date	June 2011
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Germany, Italy, Spain, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00659789
Other Study ID Numbers ^ICMJE	CT-BI Vacc-4x 2007/1, EudraCT No.: 2007-006302-13, IND Number 13619
Has Data Monitoring Committee	Yes
Responsible Party	Bionor Immuno AS
Study Sponsor ^ICMJE	Bionor Immuno AS
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bionor Immuno AS
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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