Vaccine Therapy in Preventing HPV in HIV-Positive Women in India

You may be eligible if

• 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