PDT Plus Vitamin D3 for Anal Dysplasia

Inclusion Criteria * A histological or cytological diagnosis of high-grade dysplasia or carcinoma in-situ, within past 4 months. * Premalignant lesions containing focal microinvasion are eligible when: * Surgery is not clinically mandated. * Subjects with medical conditions precluding surgery. * Subjects whose lesions cannot be completely resected based on size or location, or where significant functional morbidity would be anticipated with further surgery. * Patients refuse surgery. * The justification for inclusion of patients with microinvasive disease is based reports demonstrating the ability of photodynamic therapy to successfully treat both dysplasia and T1 squamous cell carcinoma of the anal canal * HPV positive by Cobas or other cytological assays within past 4 months * Documented HIV positivity * Patients must be on highly active anti-retroviral therapy with a CD4 count \>200 for the past 12 months * Viral load \<200 for 12 months for the past 12 months * ECOG performance status of 0-1. * 18 years of age or older. * Study subjects capable of providing informed consent. * Women of childbearing potential and men must agree to use a medically accepted method of birth control from the time they sign consent and until one month after receiving ALA Exclusion Criteria: * Study subjects in whom the lesion has invasive squamous cell carcinoma of the anal cavity which is clinically appreciable. * Clinically occult microinvasive squamous cell carcinoma of the anal …