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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: January 5, 2017
Last verified: November 2016
  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 I Infection Drug: Vacc-4x Drug: Sterile water Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:


Further study details as provided by Bionor Immuno AS:

Primary Outcome Measures:
  • 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: From Week 28 to Week 52 ]

Secondary Outcome Measures:
  • Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths [ Time Frame: Up to week 52 ]
    Brief summary of treatment emergent adverse events or related treatment emergent events and deaths. The intensity of adverse events was described according to the Division of AIDS table for grading severity of adult and pediatric adverse events, 2004.

  • Immunogenicity [ Time Frame: Week 1, week 18 and week 52 ]
    Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity) reaction. The number of participants showing induration and/or erythema

  • Effect of Vacc-4x on CD8 Counts [ Time Frame: Weeks 6,18,24,28,32,36,40,44,48,52. ]
    CD8 Count Over Time for subjects who stopped ART at Week 28 and remained off ART until Week 52

  • Time to Restart of ART for Vacc-4x Subjects Versus Placebo [ Time Frame: Between Week 28 to Week 52 ]
    Kaplan-Meier Estimate of Time to restart ART (from time coming off ART)

  • Effects on Vacc-4x on HIV-1 RNA [ Time Frame: Weeks 24,28,32,36,40,44,48,52. ]

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: Vacc-4x
Vacc-4x reconstituted in sterile water (0.1 mL) at a dose of 1.2mg per intradermal administration. Participants are given a total of 6 immunizations over 18 weeks (weeks 1, 2, 3, 4, 16, 18). Recombinant human granulocyte macrophage colony stimulating factor (rhuGM-CSF) Leukine (0.06mg in 0.1 mL) administered intradermally is used as a local adjuvant.
Drug: Vacc-4x
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
Other Name: Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.
Placebo Comparator: Placebo
Placebo injections consisting of sterile water (0.1 mL) in place of Vacc-4x. Placebo injections consisting of sterile water (0.1 mL) in place of Leukine.
Drug: Sterile water
Sterile water is used in place of Vacc-4x and in place of Leukine
Other Name: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCLA CARE Center
Los Angeles, California, United States, 90035
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048-8700
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
EPIMED GmbH
Berlin, Germany, 12157
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
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
Chelsea and Westminster Hospital
London, United Kingdom
Harrison Wing St Thomas' Hospital
London, United Kingdom
Sponsors and Collaborators
Bionor Immuno AS
Investigators
Principal Investigator: Richard Pollard, MD University of California at Davis, USA
Principal Investigator: Jürgen Rochstroh, MD Universitätsklinikum Bonn, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT00659789     History of Changes
Other Study ID Numbers: CT-BI Vacc-4x 2007/1
2007-006302-13 ( EudraCT Number )
13619 ( Other Identifier: FDA IND )
Study First Received: April 14, 2008
Results First Received: July 22, 2015
Last Updated: January 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.

ClinicalTrials.gov processed this record on July 25, 2017