Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

This is an interventional treatment trial for Infection focused on measuring infection, low-grade squamous intraepithelial lesion, atypical squamous cells of undetermined significance Read More

DISEASE CHARACTERISTICS:

Inclusion criteria:

• HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry

  • HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
• Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry

• If receiving antiretroviral therapy:

  • Receipt of antiretroviral therapy for at least 6 months prior to entry
  • No change in antiretroviral therapy within 30 days prior to entry
  • CD4 cell count > 200 cells/mm³ within 90 days prior to study entry
  • HIV-1 RNA < 200 copies/mL within 90 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, or atypical squamous cell of undetermined significance or low-grade squamous intraepithelial lesions (SIL) result within 90 days prior to entry

Exclusion criteria:

• Current or history of anal or perianal carcinoma
• Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive of HSIL, or suggestive of invasive carcinoma at screening or a history of these results

• Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry, or history of HGAIN

  • Current or history of anal or peri-anal condyloma is allowed

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Karnofsky performance status 70-100%
• Absolute neutrophil count > 750 cells/mm³
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm³
• Creatinine clearance ≥ 60 mL/min
• AST and ALT ≤ 3 times ULN
• Total or conjugated (direct) bilirubin ≤ 2.5 times ULN

Exclusion criteria:

• Serious medical or psychiatric illness, 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 the past 45 days
• Allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
• Hemophilia

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics

Exclusion criteria:

• Prior splenectomy
• Currently receiving anticoagulation therapy other than acetylsalicylic acid

• Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry

  • Routine standard of care, including hepatitis A or B, influenza, or pneumococcal and tetanus vaccines are not excluded
  • Hepatitis C co-infected patients are eligible provided no concurrent initiation of treatment for hepatitis C
• Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other HPV vaccine