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Safety of Anal Curcumin

RecruitingPhase 1

Sponsor: Lisa Flowers

Conditions: Anal High Grade Squamous Intraepithelial Lesion

Interventions: Curcuminoid Capsules

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 30 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Major 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

Locations (2)

Atlanta, Georgia, United States
Atlanta, Georgia, United States