| ACTG 5247 FACT SHEET |
| Evaluation of therapy with ZOSTAVAX ® for HIV-1-Infected Adults on ART with Conserved Immune Function.
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Purpose of This Trial:
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This FDA-approved vaccine, Zostavax ®, is used to vaccinate people over age 60 against varicella zoster virus (herpes zoster) that causes shingles and post-shingles pain.
This investigational study will see if the vaccine is safe and effective at making the body produce a reaction (antibody) to the vaccine in HIV-positive individuals.
Neither you nor your study clinician will know if you receive the vaccine or the placebo.
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Requirements to Enter Study: |
- HIV-positive, male or female, age 18 or older.
- CD4 count greater than or equal to 200 and undetectable HIV viral load
- On a combination of antiretrovirals and not planning on changing them
- History of chickenpox or herpes zoster (Shingles) more than one year prior to the study or positive for varicella zoster virus (VZV)
- No prior vaccination with varicella (chickenpox) or zoster vaccine
- Not pregnant or planning pregnancy, and willing to use birth control if needed.
- Not breast feeding
- Lowest ever (nadir) CD4 greater than or equal to 100 cells/µL.
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| Medications While on Study:
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| 2 doses of vaccine or placebo. For every 3 people who receive the vaccine, 1 will receive the placebo. The ZOSTER/Placebo vaccine will be provided to you by the study.
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| Length of Study: |
| 12-24 weeks.
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Schedule of Study Appointments: |
Screening, entry, and visits at 2, 6, 8, and 12 weeks. There will be safety telephone calls 2-3 days after each vaccination and at 24 weeks.
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| Reimbursement: |
| Exams, the ZOSTER/Placebo vaccine and lab tests are provided at no cost. You will receive $20 per visit starting at entry.
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Contact: |
| The ACTU Screening Nurse at (206) 744-3184 |
