Clinical trial NCT00659789: Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV I Infection
Lead sponsor: Bionor Immuno AS
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
timeFrame: From Week 28 to Week 52
Secondary outcomes:
measure: Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths
timeFrame: Up to week 52
measure: Immunogenicity
timeFrame: Week 1, week 18 and week 52
measure: Effect of Vacc-4x on CD8 Counts
timeFrame: Weeks 6,18,24,28,32,36,40,44,48,52.
measure: Time to Restart of ART for Vacc-4x Subjects Versus Placebo
timeFrame: Between Week 28 to Week 52
measure: Effects on Vacc-4x on HIV-1 RNA
timeFrame: Weeks 24,28,32,36,40,44,48,52.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CARE Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern University Division of Infectious Diseases
state: Illinois
city: Berlin
country: Germany
facility: EPIMED GmbH
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Hamburg
country: Germany
facility: ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Köln
country: Germany
facility: Klinik I für Innere Medizin Klinikum Der Universität zu Köln
city: Milano
country: Italy
facility: Istituto San Raffaele
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: Harrison Wing St Thomas' Hospital
Study officials:
affiliation: University of California at Davis, USA
name: Richard Pollard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Bonn, Germany
name: Jürgen Rochstroh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pollard RB, Rockstroh JK, Pantaleo G, Asmuth DM, Peters B, Lazzarin A, Garcia F, Ellefsen K, Podzamczer D, van Lunzen J, Arasteh K, Schurmann D, Clotet B, Hardy WD, Mitsuyasu R, Moyle G, Plettenberg A, Fisher M, Fatkenheuer G, Fischl M, Taiwo B, Baksaas I, Jolliffe D, Persson S, Jelmert O, Hovden AO, Sommerfelt MA, Wendel-Hansen V, Sorensen B. Safety and efficacy of the peptide-based therapeutic vaccine for HIV-1, Vacc-4x: a phase 2 randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2014 Apr;14(4):291-300. doi: 10.1016/S1473-3099(13)70343-8. Epub 2014 Feb 11.