Status:
WITHDRAWN
Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study
Lead Sponsor:
University of Zurich
Conditions:
Herpes Zoster
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal is to demonstrate the immunogenicity and safety of Zostavax® in HIV positive individuals. Study participants are stratified into different patient groups according to their CD4 cell count, vi...
Eligibility Criteria
Inclusion
- Inclusion criteria: All individuals
- Age \>18 years
- Male, or female with negative urine pregnancy test
- VZV-seropositive (serologically documented)
- Agree to use a barrier method of birth control (such as a condom)
- Written informed consent HIV positive individuals on ART (group A1-A3)
- Continuous ART for \>3 months before baseline
- No change of ART regimen within 1 month before baseline
- HIV-RNA (value must be \<3 months old )\<50 copies/ml at last visit
- CD4-count (value must be \<3 months old) \> 500 cells/µl for group A1, 350-500 cells/µl for group A2 and 250 -349 cells/µl for group A3
- Participation in the SHCS HIV-positive individuals without ART (group B)
- HIV-1 RNA \>1000 copies/ml (\<3 months before baseline)
- CD4-cell count \>500 cells/µl (\<3 months before baseline)
- Participation in the SHCS Healthy HIV-negative volunteers (group C)
- Negative HIV-screening test (\<3 months before baseline)
- CD4 cell count \>500 cells/µl
- Exclusion criteria: Common exclusion criteria
- Contraindications on ethical grounds
- Involvement in a conflicting (vaccine or investigational drug) clinical trial (except from the participation in the Swiss HIV Cohort Study).
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the subject.
- Pregnancy or breast feeding.
- Other clinically relevant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
- Known or suspected non-compliance, drug- or alcohol abuse.
- Specific exclusion criteria
- Fever \> 38.3 °C or acute illness during the last 4 weeks
- Exposure to chickenpox or shingles within four weeks prior to study entry
- History of shingles
- Immunosuppression due to disease (other than HIV) or due to medication within 30 days of study entry (eg corticosteroids)
- Household contact with known immunodeficiency (e.g. HIV-positive with CD4 \<250 cells/µl)
- Immunoglobulin or blood product treatment within 1 year prior or 2 month after study vaccination
- Previous allergic reaction to vaccine components (i.e. neomycin or gelatin)
- Vaccination with a life attenuated vaccine one month prior to study entry
- History of chickenpox vaccination
- Treatment with anti-herpes drugs 4 weeks before baseline
- Severe coagulation disorder or oral anticoagulant treatment
- Laboratory exclusion criteria.
- Thrombocytopenia \< 50x 103/?l
- Haemoglobin \<12 g/dl
- More than threefold elevation of ALT
- Creatinine of more than150 µmol/l
- Glucose \>10 mmol/l
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01213810
Start Date
December 1 2010
End Date
June 1 2012
Last Update
March 1 2013
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