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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

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 ]

Enrollment: 137
Study Start Date: August 2008
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Vacc-4x immunization
 Drug: Vacc-4x
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally
Placebo Comparator: B
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
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-8700
UCLA CARE Center
Los Angeles, California, United States, 90035
UC Davis Medical Center
Sacramento, California, United States, 95817
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
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
EPIMED GmbH
Berlin, Germany, 12157
Universitätsklinikum Bonn
Bonn, Germany, 53127
ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
Hamburg, Germany, 20099
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Klinik I für Innere Medizin Klinikum Der Universität zu Köln
Köln, Germany, 50937
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
Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre
Brighton, United Kingdom, BN2 1EE
Harrison Wing St Thomas' Hospital
London, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Sponsors and Collaborators
Bionor Immuno AS
  More Information

No publications provided

Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT00659789     History of Changes
Other Study ID Numbers: CT-BI Vacc-4x 2007/1, EudraCT No.: 2007-006302-13, IND Number 13619
Study First Received: April 14, 2008
Last Updated: February 2, 2012
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013