Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

Exclusion Criteria

• •History of any prior vaccination with an HPV vaccine
• •Active anogenital warts within three months prior to study entry) or history of cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)
• •Previous allergic reaction to any constituents of the HPV vaccine
• •Pregnancy
• •Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
• •Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
• •Presence of any known \> Grade 3 clinical or laboratory toxicity at the time of study entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
• •Receipt of any routine vaccine within four weeks prior to study entry
• •Receipt of any immune globulin or plasma product within six months prior study entry
• •Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
• •Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry
• •Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry
• •Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection
• •Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of prednisone or equivalent for \> 2 consecutive weeks)
• •Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy
• •If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment