AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males

Inclusion Criteria

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