Actively Recruiting

Phase 1
Age: 30Years +
All Genders
Healthy Volunteers
NCT06626230

Safety of Anal Curcumin

Led by Lisa Flowers · Updated on 2025-04-23

48

Participants Needed

2

Research Sites

41 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Safety of Anal Curcumin

Who Can Participate

Age: 30Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 30 years of age or older
  • Have biopsy-proven anal intraepithelial neoplasia (AIN) 2 or AIN 3 without previous treatment
  • Or have cytology results showing ASC-H or HSIL
  • Able and willing to complete a study diary
  • Other inclusion criteria apply
Not Eligible

You will not qualify if you...

  • Have a clinically significant progressive chronic medical condition such as coronary disease, congestive heart failure, chronic obstructive lung disease, or diabetes mellitus
  • History of anal cancer
  • Pregnant or planning pregnancy within the next three months
  • History of sensitivity or allergy to any compound used in this study
  • Have Grade 2 or higher renal or hematology abnormalities
  • Current or past year use of intravenous drugs (except therapeutic use), recreational drugs, or alcohol abuse
  • Other exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

Actively Recruiting

2

Grady Hospital - Ponce De Leon Clinic

Atlanta, Georgia, United States, 30308

Actively Recruiting

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Research Team

L

Lisa Flowers, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

8

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Safety of Anal Curcumin | DecenTrialz