A5212
Immunogenicity
& Safety of a Quadrivalent HPV Vaccine in HIV-1-Infected
Females
Purpose of this Study: This study
will see if the HPV vaccine, when given in 3 separate
doses, is safe and tolerable in females infected with
HIV. This will be done by asking 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
the body make substances in response to the vaccination
to help fight off disease caused by HPV.
Requirements to Enter Study:
- Participants must be HIV positive.
- Females ages 13 (change for your site if you
need to) to 45.
- Any T-cell count and any viral load is acceptable.
- If you are taking antiretroviral drugs, you
must be on the same combination of medicines for
at least 12 weeks before the study entry visit.
You do not need to be on antiretroviral drugs
to be eligible for this study.
- No cervical cancer, very abnormal Pap smear,
or genital warts within 180 days.
- No prior vaccinations for HPV.
- Cannot take any of the disallowed medications.
Your study nurse will discuss these with you.
Treatment: Study treatment is
defined as quadrivalent HPV (types 6, 11, 16, 18)
recombinant vaccine, Gardasil, and will be provided
to you by the study. Quadrivalent means that the vaccine
is directed at four types of HPV. If you are currently
taking antiretroviral drugs, you should continue taking
them unless your doctor tells you otherwise. Your
antiretroviral drugs will not be provided to you by
the study. You must get them through your primary
care provider.
Duration of Study: This study
will last about one and a half years.
For
more information contact:
Study
Contacts
Aleshia
Thomas , RN (215) 349-8092
