| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19104 |
| Conditions: |
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Herpes Zoster - HIV Infections |
| Purpose: |
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Herpes zoster, or shingles, is the result of a viral infection that causes a painful skin
rash, usually in older people or people with suppressed immune systems like those infected
with HIV. The ZOSTAVAX vaccine has been shown to reduce the number of infections and
symptoms of herpes zoster infection in people over the age of 60. The purpose of this study
is to test the safety and tolerability of ZOSTAVAX in HIV-infected adults.
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| Study summary: |
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The varicella-zoster virus (VZV) which causes herpes zoster (HZ), or shingles, is associated
with a painful skin rash and post-herpetic neuralgia (PHN). The incidence and severity of HZ
and PHN increase as immune function decreases, as in elderly or HIV-infected people. The
live VZV vaccine, ZOSTAVAX, has been shown to reduce the incidence and severity of HZ and
PHN in people over the age of 60. The main purpose of this study is to determine whether a
two-dose regimen of ZOSTAVAX is safe and well-tolerated in HIV-infected individuals with
conserved immune function.
This study has two stages and three arms. It may last up to 24 weeks per subject. In Stage
1, 48 participants with CD4 cell counts of 200 or more cells/microliter will be enrolled (24
participants with a CD4 count between 200 and 349 cells/microliter and 24 participants with
a CD4 count equaling 350 or more cells/microliter). These participants will be randomized to
receive two doses of ZOSTAVAX or placebo at least six weeks apart. If certain safety
criteria are met for Stage 1, enrollment will be opened to Stage 2. In Stage 2, participants
will be stratified using the same parameters as Stage 1 and will then be randomized to
receive either two doses of vaccine or placebo. Participants will be followed for at least
42 days after each vaccination.
Temperatures will be collected daily for 42 days following each vaccination. Telephone
contact will also be made 2 to 3 days after each vaccination and at 24 weeks following the
initial vaccination to obtain information regarding vaccination-related symptoms.
All participants will have between 6 and 8 study visits. At the screening visit,
documentation of HIV status is required, and blood and urine collection, a physical exam,
medical history, and clinical assessment will occur. At each visit, a targeted physical exam
will occur. At some visits, blood and urine collection, and a clinical assessment will
occur. Antiretroviral medications are not provided by this study. |
| Criteria: |
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Inclusion Criteria:
- HIV infected
- Use of potent combination ART regimen within 90 days prior to entry and undetectable
plasma HIV RNA level within 90-210 days prior to study entry
- CD4 cell count of at least 200 cells/microliter obtained within 30 days prior to
study entry
- Laboratory values obtained within 90 days prior to study entry
- Hemoglobin 7.0 g/dL or greater
- Platelet count 50,000/mm3 or greater
- Creatinine 3 x ULN or less
- AST (SGOT), ALT (SGPT), and alkaline phosphatase 5 x ULN or less
- For females of reproductive potential, a negative serum or urine pregnancy test
within 24 hours prior to study entry
- Willing to use accepted forms of contraception for the duration of the study
- History of varicella or herpes zoster more than 1 year prior to vaccination or VZV
seropositivity at any time prior to entry
Exclusion Criteria:
- Known or suspected immune dysfunction caused by a medical condition or any cause
other than HIV infection, such as congenital immunodeficiency, organ or bone marrow
transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or
generalized malignancy [NOTE: Subjects with prostate or breast cancer who are not on
chemotherapeutic drugs (other than hormone blocking drugs), subjects with skin cancer
or Kaposi's sarcoma limited to skin who are not receiving radiation therapy or
chemotherapy, and subjects with a history of other malignancies who have been
disease-free for at least 5 years will be eligible for enrollment.]
- Receipt of any varicella or zoster vaccine prior to study entry
- History of allergy/sensitivity, or hypersensitivity to any vaccine component,
including gelatin or neomycin
- Receipt of immunoglobulin or any blood products, other than autologous blood
transfusion, given during the 5 months prior to study entry or expected during the
24-week study period
- Receipt of any live virus vaccine within 28 days prior to study entry or during study
period
- Receipt of any inactivated vaccine within 7 days prior to study entry or during study
period
- Scheduled administration of any live virus vaccine or inactivated vaccine at or
between study entry and the Week 12 visit
- Participation in an investigational drug study within the last 30 days prior to study
entry
- Any illness that might interfere with the interpretation of the study or prevent
completion of the study
- Use of immunosuppressive therapy. More information can be found in the protocol.
- Any suppressive antiviral therapy with activity against herpes viruses within 7 days
prior to study entry or during study period, except where necessary for acute
treatment of intercurrent viral infection.
- Any episode of VZV reactivation in the 12 months prior to study entry
- Active drug or alcohol use, dependence, or any other reason that, in the opinion of
the site investigator, would interfere with the study
- Pregnancy or breast feeding |
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| Study is available at: |
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University of Pennsylvania CRS
Philadelphia, PA 19104
United States
Primary Contact:
Joseph Quinn, RN
Email: joseph.quinn@uphs.upenn.edu
Phone: 215-349-8092 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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