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

Inclusion 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