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

This is an interventional prevention trial for Anal Cancer focused on measuring human papilloma virus infection, anal cancer, penile cancer, HIV infection Read More

DISEASE CHARACTERISTICS:

• 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 (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

• Meets one of the following sets of criteria:

  • Patients 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

  • Patients 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, LSIL/condyloma, or ASCUS result within 90 days prior to entry, and no HGAIN on biopsy

  • No current or history of anal or peri-anal carcinoma
  • No 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
• No presence of penile or scrotal condyloma, LGAIN (condyloma or AIN 1), HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry on biopsy
• No history of HGAIN

PATIENT CHARACTERISTICS:

• Karnofsky performance score ≥ 70 within 45 days prior to entry
• Absolute neutrophil count (ANC) > 750 cells/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm^3
• AST (SGOT), ALT (SGPT) ≤ 3 times upper limit of normal (ULN)
• Total or conjugated (direct) bilirubin ≤ 2.5 times ULN within 45 days before study entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
• Calculated creatinine clearance ≥ 60 mL/min
• No hemophilia
• No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
• No serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
• No 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
• No allergy to yeast or any of the components of Gardasil

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior splenectomy
• No prior receipt of Gardasil or other HPV vaccine
• No use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry

• No 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

  • No patients with hepatitis C who expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
• Not currently receiving anticoagulation therapy other than acetylsalicylic acid