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.