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

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

MedlinePlus related topics:

AIDS Drinking Water

U.S. FDA Resources

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

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. [ 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:	345
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 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
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
Documented 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	Recruiting
	Sacramento, California, United States, 95817
	Contact: Richard Pollard, MD 916-734-3742 rbpollard@ucdavis.edu
	Principal Investigator: Richard Pollard, MD

Sponsors and Collaborators

Bionor Immuno AS

More Information

Responsible Party:	Bionor Immuno AS ( Bionor Immuno AS )
Study ID Numbers:	CT-BI Vacc-4x 2007/1, EudraCT No.: 2007-006302-13
First Received:	April 14, 2008
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00659789
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 17, 2008

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