A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

An open-label, single arm study with stratification by CD4 cell count and HIV viral load to assess the immunogenicity, safety and tolerability of the quadrivalent human papillomavirus (HPV) recombinant vaccine (Gardasil) directed against virus types 6, 11, 16 and 18.

The primary objective is to determine the development of antibody levels to HPV types 6, 11, 16 and 18 after the Gardasil vaccine series is completed in subjects with various levels of CD4 and HIV viral load levels.

All subjects will receive the complete series of three doses of the Gardasil vaccine. 

The study visits are screening, entry, then at weeks four, eight, 12, 24, 28, 52 and 72.

• In order to participate you must:

  • Have HIV infection
  • Have CD4 cell levels less than or equal to 350
  • Be on the same HIV medications for the past 12 weeks
  • Use at least one method of contraception if able to conceive
  • Have a cervix (hysterectomy is OK as long as you still have a cervix)

  You will not be able to be in the study if you:

  • Have no cervix, are pregnant or are breast feeding
  • Had an abnormal pap test with biopsy-confirmed CIN2, or CIN3 within 180 days (six months) of entry
  • Had biopsy-confirmed vaginal or cervical cancer within 180 days of entry
  • Had a diagnosis of genital warts within 180 days of entry
  • Had cervical dysplasia treatment within 180 days of entry
  • Have serious illness requiring systemic treatment or hospitalization within 45 days of entry
  • Had prior vaccination with any HPV vaccine