Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males

Inclusion Criteria

• Men with a history of at least one male sexual partner * “Men” is defined as those documented “male” at birth (including male-to-female transgendered persons)
• HIV-1 infection as documented by any federally approved, licensed HIV test performed in conjunction with screening (enzyme linked immunosorbent assay [ELISA], Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests; if the participant’s HIV status is documented by an outside physician, the protocol team strongly recommends obtaining a copy of the HIV laboratory reports from this physician; all confirmatory tests and the physician’s note must be on file before the participant is enrolled; in the rare circumstance where only an outside physician’s note with no supporting laboratory documentation is available, the local site should have additional tests performed to verify the participant’s HIV status; one of the following additional tests should be performed: * A rapid HIV test * ELISA and Western blot * Chemiluminescence immunoassay and Western blot * HIV ribonucleic acid (RNA) > 2000 copies/mL * HIV antigen test
• If receiving antiretroviral therapy: * Receipt of antiretroviral therapy for at least 3 months prior to entry * No change in antiretroviral therapy within 30 days prior to entry
• If not receiving antiretroviral therapy: * CD4-cell count >= 350 cells/mm³ within 90 days prior to study entry * No plans to start antiretroviral therapy prior to week 28
• Normal anal cytological result, low-grade intraepithelial lesions (LSIL)/condyloma or atypical squamous cells of undetermined significance (ASCUS) result within 90 days prior to entry, and no by high-grade anal intraepithelial neoplasia (HGAIN) on biopsy
• Absolute neutrophil count (ANC) > 750 cells/mm^3
• Hemoglobin >= 9.0 g/dL
• Platelet count >= 100,000/mm^3
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X upper limit of normal (ULN)
• Total or conjugated (direct) bilirubin =< 2.5 X ULN within 45 days prior to entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
• Calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault formula)
• Karnofsky performance score >= 70 within 45 days prior to entry

Exclusion Criteria

• Current or history of anal or peri-anal carcinoma
• Anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
• HGAIN (e.g., anal intraepithelial neoplasia [AIN] 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) or invasive carcinoma at pre-entry on biopsy, or participant has a history of invasive carcinoma or any prior anal cytology result of HSIL or ASC-H
• Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry
• It is encouraged that standard of care vaccinations are not offered during the 2 weeks preceding plasma HIV-1 RNA measurements, and that standard of care vaccinations are not administered at the same time as the study vaccine; routine vaccinations other than influenza vaccine that are administered after enrollment in the study should be given 1 month before or after HPV vaccination (or any visit where antibody titers are measured) during the study period. Influenza vaccination may be given within 1 week before or after HPV vaccination visits
• Expected use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids used for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG during study followup; hepatitis C co-infected subjects should not enroll in this study if they expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
• Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
• Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
• Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol
• Subject is currently receiving anticoagulation therapy other than acetylsalicylic acid
• Inability to provide informed consent (and assent, if subject is under the age of 18)
• Allergy to yeast or any of the components of Gardasil
• Prior splenectomy
• Hemophilia
• Prior receipt of Gardasil or other HPV vaccine