Safety of Anal Curcumin
Sponsored by Lisa Flowers
About this study
The purpose of this study is to see if curcumin can reverse anal high-grade squamous intraepithelial lesions (aHSIL) (high-grade anal precancerous cells or high-grade abnormal cells) in people living with HIV to avoid current treatments such as ablation (destroying abnormal cells with heat or surgical excision (cutting out the abnormal cells)), which have potential short- and long-term side effects.
This proposal suggests conducting a Phase I clinical trial using a 3 + 3 dose escalation approach to assess the safety and determine the maximum tolerated dose of intra-anal curcumin in individuals with HIV who have anal high-grade squamous intraepithelial lesions (aHSIL/AIN 2-3). Currently, there is a significant need for non-surgical treatments for pre-malignant anal diseases in people with HIV, aiming to reduce risks and complications associated with existing surgical and topical interventions. Curcumin, a compound derived from turmeric, is known for its anti-inflammatory and anti-infectious properties. While previous research has shown its anticancer effects in oral doses, its bioavailability is limited, and intra-anal administration has not been studied in humans. This trial aims to …
Where this study is enrolling (2)
- I'm interested
Grady Hospital - Ponce De Leon Clinic
Atlanta, Georgia
- I'm interested
Grady Memorial Hospital
Atlanta, Georgia
Who can participate
Inclusion criteria
- ✓30 and older
- ✓Have biopsy-proven anal intraepithelial neoplasia (AIN) 2, AIN 3 without previous treatment
- ✓Or cytology results for ASC-H or HSIL
- ✓Able and willing to complete Study Diary
- ✓Other inclusion criteria apply
Exclusion criteria
- ✕Have a clinically significant chronic medical condition that is considered progressive, such as but not limited to coronary disease, congestive heart failure, chronic obstructive lung disease, and diabetes mellitus. Chronic nonprogressive or intermittent syndromes are not excluded, including migraine headaches, mild reactive airway disease, controlled hypertension, stable pain syndromes, or benign gastric reflux.
- ✕Have any history of anal cancer malignancy.
- ✕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,
- ✕Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), recreational drugs, or alcohol abuse.
- ✕Other exclusion criteria apply
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.