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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659789
• Other study ID #: CT-BI Vacc-4x 2007/1
• Secondary ID: 2007-006302-1313
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2008
• Last updated: January 27, 2015
• Start date: August 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2010
• Source: Bionor Immuno AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeGermany: Paul-Ehrlich-InstitutGermany: Ethics CommissionItaly: Ethics CommitteeSpain: Spanish Agency of MedicinesSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Vacc-4x
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally
• Sterile water
Sterile water for injection.

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	EPIMED GmbH	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George	Hamburg
Germany	Universitätsklinikum Hamburg Eppendorf	Hamburg
Germany	Klinik I für Innere Medizin Klinikum Der Universität zu Köln	Köln
Italy	Istituto San Raffaele	Milano
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.	Barcelona
United Kingdom	Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre	Brighton
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	Harrison Wing St Thomas' Hospital	London
United States	Northwestern University Division of Infectious Diseases	Chicago	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UCLA CARE Center	Los Angeles	California
United States	University of Miami School of Medicine	Miami	Florida
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Bionor Immuno AS

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Week 52	Yes
Secondary	Safety and tolerability of Vacc-4x		Several points throughout the study	Yes
Secondary	Immunogenicity of Vacc-4x evaluated by DTH (Delayed-type Hypersensitivity)		Several points throughout the study	Yes
Secondary	Effect of Vacc-4x on CD8 counts and HIV viral RNA		Several points throughout the study	Yes
Secondary	Time to restart of ART for Vacc-4x subjects versus placebo		Several points throughout the study	Yes