Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

OBJECTIVES: Primary * To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men. * To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline. Secondary * To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series. * To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response. * To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline. * To evaluate the oral levels of serum IgA before and after the vaccination series. Tertiary * To evaluate prevalent and incident HPV infections in the anal canal. * To evaluate cytological and histological abnormalities in the anal canal. * To evaluate prevalent and incident HPV infections in the oral cavity. * To compare oral and anal compartmental shedding of HPV before and after vaccination. OUTLINE: This is a multicenter study. Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24. After completion of protocol therapy, patients are followed at 7, 12, and 18 months.