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

April 14, 2008
February 2, 2012
August 2008
June 2010   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00659789 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: Vacc-4x
    Vacc-4x is a peptide-based HIV immunotherapy administered intradermally
  • Drug: Sterile water
    Sterile water for injection.
  • Experimental: A
    Vacc-4x immunization
    Intervention: Drug: Vacc-4x
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Sterile water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
June 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Italy,   Spain,   United Kingdom
 
NCT00659789
CT-BI Vacc-4x 2007/1, EudraCT No.: 2007-006302-13, IND Number 13619
Yes
Bionor Immuno AS
Bionor Immuno AS
Not Provided
Not Provided
Bionor Immuno AS
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP