Recruiting
Phase 1

Curcumin

Sponsor:

Lisa Flowers

Code:

NCT06626230

Conditions

Anal High Grade Squamous Intraepithelial Lesion

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

Interventions

Curcuminoid Capsules

Study Details

Brief summary:

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

Study ID

NCT06626230

Start date

Mar 17, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Level 1

Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period

experimental: Dose Level 2

Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period

experimental: Dose Level 3

Participants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period

experimental: Dose Level 4

Participants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period

experimental: Dose Level 5

Participants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period

experimental: Dose Level 6

Participants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period

experimental: Dose Level 7

Participants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period

experimental: Dose Level 8

Participants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period

Interventions

Curcuminoid Capsules

500 mg curcuminoids from C3 Complex capsule. Curcuma longa (Turmeric), a constituent of the spice turmeric, is considered a low-toxicity, dietary-derived agent with chemopreventive and therapeutic benefits Study participants will be instructed to insert the curcumin capsules gelatin intra-anally every day for a 14-day treatment period.

Escalating doses

Primary outcome measure

  • Maximum curcumin tolerated dose [ Time Frame: Up to 22 days after treatment ]

Central Contacts and Locations

Central contacts

Lisa Flowers, MD, MPH

404-251-8931lflowe2@emory.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Grady Hospital - Ponce De Leon Clinic

Recruiting

Atlanta, Georgia, United States, 30308

Principal Investigator:

Lisa Flowers, MD

More Information

Sponsor

Lisa Flowers

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • HSIL/AIN 2-3
  • Curcumin
  • Cancer
  • Human Papillomavirus (HPV)
  • HIV
  • Curcuminoids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lisa Flowers on 2026-08-18.