Curcumin for the Treatment of Precancerous Anal Lesions in Patients with HIV

Inclusion Criteria

• 30 years and over of age at enrollment
• Able to provide written informed consent
• Sign partner notification attestation form
• Have biopsy proven anal intraepithelial neoplasia (AIN) 2 and AIN 3 without previous treatment
• Or cytology results for ASC-H or HSIL
• Able and willing to complete study diary
• Agree to abstain from sexual intercourse for 48 hours prior to the enrollment visit
• Agree to insert curcumin gelatin capsules as required per protocol
• Agree to abstain from nonsteroidal anti-inflammatory drugs (NSAIDS) during the 15 days
• Agree to abstain from all products containing curcumin or food consumption of curcumin during the 15 days
• Agree to abstain from the following activities for at least 48 hours prior to enrollment through the day 15 visit: * Insertion of objects into the anus * Receiving anal sex * Participating in other anal studies

Exclusion Criteria

• Have a clinically significant chronic medical condition that is considered progressive, including: coronary disease, congestive heart failure, chronic obstructive lung disease, diabetes mellitus, chronic renal disease, active peptic ulcer disease, chronic hepatic disease, multiple sclerosis, seizure disorder requiring medication, and a coagulation or platelet disorder. Chronic nonprogressive or intermittent syndromes are not excluded, including migraine headaches, mild reactive airways disease, controlled hypertension, stable pain syndromes, or benign gastric reflux
• Have any history of anal cancer malignancy
• Are pregnant or planning to become pregnant in the next three months
• Have a history of sensitivity or allergy to any compound used in this study
• Have grade 2 or higher renal or hematology abnormality, as defined by the Table for Grading the Severity of Adult Adverse Events
• In the three months before enrollment, participants must not have had treatment for anal disease
• Signs, as seen on anal exam at screening, consistent with an STD (sexually transmitted disease)
• Signs, as seen on anal exam, consistent with anal fissure
• Signs of anal infection from laboratory evaluations
• In the three months prior to enrollment have had any of the following: * History of treatment for or a diagnosis with a new STD * Exchanged sex for money, drugs, or gifts
• Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), crack or other recreational drugs, abused alcohol defined as alcohol use that has required hospital admission for detoxification and therapy
• Have any other condition that in the opinion of the investigator might interfere with the evaluation of the study objectives