Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
Condition: Infection; Precancerous Condition
MeSH terms: Infections; Precancerous Conditions
Intervention: Gardasil
Intervention description: week 0, 8, 24, 128
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: infection; low-grade squamous intraepithelial lesion; atypical squamous cells of undetermined significance

Summary:

      RATIONALE: Vaccines made from human papillomavirus may help the body build an effective
      immune response to kill HIV cells.

      PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus
      vaccine therapy works in treating men with HIV-1 infection.
    

Eligibility criteria:

        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