Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
Condition: Anal Cancer; Nonneoplastic Condition; Penile Cancer; Precancerous Condition
MeSH terms: Anus Neoplasms; Precancerous Conditions; Penile Neoplasms; Disease
Intervention: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; laboratory biomarker analysis
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: Male
Minimum age: 13 Years
Maximum age: 26 Years
Healthy volunteers: No
Keywords: human papilloma virus infection; anal cancer; penile cancer; HIV infection

Summary:

      RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective
      immune response to prevent viral infection.

      PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human
      papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.
    

Eligibility 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