This is a pilot study in which all participants will be vaccinated with a Human Papillomavirus (HPV) vaccine.  A quadrivalent vaccine is one that targets four parts of the virus.  All participants will be inoculated with the vaccine (Gardasil®) by an injection into their muscle at Day 0, Week 8 and Week 24.  The primary objectives are to evaluate the safety and tolerability of the HPV vaccine in HIV positive men and to determine whether the vaccine produces the appropriate immune response (the person develops antibodies against HPV).  Eligible participants must be test negative for HPV 16 and/or HPV 18 (two different types of HPV). A maximum of 20 subjects who are positive for HPV 16 will be enrolled and a maximum of 20 subjects who are positive for HPV 18 will be enrolled. Participants are excluded if they have had a test showing indication of pre-cancerous cells in their anus or if they have anal cancer.  Duration of the study: 72 weeks.

Inclusion Criteria

• HIV positive men, 18 years of age or older.
• Anal HPV negative test result for either type 16 and/or type 18 within 45 days prior to entry
• If on HIV antiretroviral therapy, must be on stable therapy at least 6 months prior to study entry, with no changes to the regimen within 30 days of study entry.  T-cells must be above 200 cells/ mm3 and viral load less than 200 copies/mL within 90 days of study entry.
• If not on HIV antiretroviral therapy, must have a T-cell count greater than or equal to 350 cells/mm3 within 90 days prior to study entry, with no plans to start HIV therapy prior to week 28 of the study.
• Normal anal pap smear results within 45 days of study entry.
• Lab results within normal ranges

Exclusion Criteria

• Current or history of anal or peri-anal cancer or indication of pre-cancerous cells.
• Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
• Prior splenectomy, any acute infection or hemophilia, allergy to the yeast component of the vaccine.
• Have ever been vaccinated by Gardasil® or another HPV vaccine in the past.

Principal Investigator: Ronald Mitsuyasu, MD

If you think you might be interested in participating in this study, please contact Blanca Corea at 310-557-9062 or email at bcorea@mednet.ucla.edu

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