Safety of Anal Curcumin

Description

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.

Conditions

Anal High Grade Squamous Intraepithelial Lesion

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Study Overview

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Study Details

Study overview

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.

An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin

Safety of Anal Curcumin

Condition
Anal High Grade Squamous Intraepithelial Lesion
Intervention / Treatment

-

Contacts and Locations

Atlanta

Grady Memorial Hospital, Atlanta, Georgia, United States, 30303

Atlanta

Grady Hospital - Ponce De Leon Clinic, Atlanta, Georgia, United States, 30308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 35 and older
  • * Have biopsy-proven anal intraepithelial neoplasia (AIN) 2 and AIN 3 within 4 months of enrollment.
  • * Able and willing to complete Study Diary
  • * Other inclusion criteria apply
  • * 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

Ages Eligible for Study

35 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Lisa Flowers,

Lisa Flowers, MD, MPH, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2026-01