| ACTG 5240 FACT SHEET |
| Immunogenicity & Safety of an HPV Vaccine in HIV-Positive Women
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Purpose of This Trial:
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Human papillomavirus (HPV) is a common virus that causes warts, and can also cause cervical, vulvar and anal cell growth problems (dysplasia) leading to cancer. A new, FDA-approved HPV vaccine has been shown to prevent HPV infection and cervical dysplasia among HIV-negative women. However, the HPV vaccine has not yet been studied among HIV-positive women.
This study will see if the HPV vaccine is safe and effective in HIV-positive women and girls. If you join the study, you will receive 3 injections of the HPV vaccine. We will ask you how you feel and if you had any reactions after each dose of the vaccine. The study will also check if the HPV vaccine can help you develop immunity to help fight off HPV infection.
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Requirements to Enter Study: |
- HIV positive, female, age 18-45.
- Any CD4 count and any viral load
- On stable HIV medications, or not on any HIV medications, for at least 12 weeks before joining the study.
- No history of cervical cancer, very abnormal Pap smear, or genital warts within 6 months
- Have never received an HPV vaccine
- Not pregnant or planning pregnancy, and willing to use birth control if needed.
- Not breast feeding
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| Medications While on Study:
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| The HPV vaccine (Gardasil ®) will be provided to you by the study.
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| Length of Study: |
| 72 weeks.
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Schedule of Study Appointments: |
Screening, Entry, and Visits at 4, 8, 12, 24, 28, 52, and 72 weeks
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| Reimbursement: |
| Exams, the HPV vaccine and lab tests are provided at no cost. You will receive $20-50* per visit, or up to $250 total if you complete all study visits.
*$20 for most visits; $50 if the visit involves a pelvic/rectal exam
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Contact: |
| The Screening Nurse at (206) 744-3184 |
