Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
- Registration Number
- NCT00659789
- Lead Sponsor
- Bionor Immuno AS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vacc-4x 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. Placebo Sterile water 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.
- Primary Outcome Measures
Name Time Method Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52. From Week 28 to Week 52
- Secondary Outcome Measures
Name Time Method Effect of Vacc-4x on CD8 Counts 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 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 Weeks 24,28,32,36,40,44,48,52. Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths 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 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
Trial Locations
- Locations (18)
Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Harrison Wing St Thomas' Hospital
🇬🇧London, United Kingdom
Brighton and Sussex University Hospital, HIV/GUM Research, Elton John Centre
🇬🇧Brighton, United Kingdom
EPIMED GmbH
🇩🇪Berlin, Germany
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Istituto San Raffaele
🇮🇹Milano, Italy
Klinik I für Innere Medizin Klinikum Der Universität zu Köln
🇩🇪Köln, Germany
UC Davis Medical Center
🇺🇸Sacramento, California, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
UCLA CARE Center
🇺🇸Los Angeles, California, United States
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
ifi - Studien und Projekte GmbH, an der Asklepios-Klinik St. George
🇩🇪Hamburg, Germany
Unidad de VIH, Hospital de Bellvitge, Calle Feixa Llarga s/n, Hospitalet de Llobregat.
🇪🇸Barcelona, Spain
Northwestern University Division of Infectious Diseases
🇺🇸Chicago, Illinois, United States