Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
Condition: Cervical Cancer; Nonneoplastic Condition; Precancerous Condition
MeSH terms: Uterine Cervical Neoplasms; Precancerous Conditions; Disease
Intervention: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; DNA analysis; polymerase chain reaction; cytology specimen collection procedure; colposcopic biopsy
Intervention description: Vaccination with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular (IM) injection at Day 0, Weeks 8 and 24.; Weeks 0, 2, 10, 26, and 52.; Screening, week 36, and week 52.; Screening, week 36, and week 52.; Screening, week 36, and week 52.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: human papilloma virus infection; cervical cancer; cervical intraepithelial neoplasia; HIV infection

Summary:

      RATIONALE: Vaccines made from virus proteins may help the body build an effective immune
      response to prevent cervical cancer.

      PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine
      and how well it works in preventing cervical cancer in women in India with HIV-1 infection.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western
             blot before 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

          -  Meets 1 of the following criteria:

               -  Nadir CD4 level of ≤ 350 cells/mm³ and receiving highly active antiretroviral
                  therapy (HAART) for at least 6 months before study entry

               -  Nadir CD4 level of > 350 cells/mm³ and not receiving HAART at the time of study
                  entry

          -  No known history of high-grade CIN or cervical cancer

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  ANC > 750 cells/mm³

          -  Hemoglobin ≥ 9.0 g/dL

          -  Platelet count ≥ 100,000/mm³

          -  Serum creatinine ≤ 3 times upper limit of normal (ULN)

          -  AST and ALT ≤ 3.0 times ULN

          -  Conjugated (direct) bilirubin ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active drug or alcohol use or dependence that would interfere with adherence to
             study requirements, in the opinion of the site Investigator

          -  No serious illness requiring systemic treatment and/or hospitalization within the past
             45 days

          -  No allergy to yeast or any of the components of quadrivalent human papillomavirus
             (types 6, 11, 16, 18) recombinant vaccine

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 45 days since prior systemic antineoplastic or immunomodulatory treatment,
             systemic corticosteroids, investigational vaccines, interleukins, interferons, growth
             factors, or intravenous immunoglobulin

               -  Routine standard of care, including hepatitis B, influenza, and tetanus vaccines
                  are allowed