NCT06626230

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

October 1, 2024

Last Update Submit

April 17, 2025

Conditions

Anal High Grade Squamous Intraepithelial Lesion

Keywords

HSIL/AIN 2-3CurcuminCancerHuman Papillomavirus (HPV)HIVCurcuminoids

Outcome Measures

Primary Outcomes (1)

  • Maximum curcumin tolerated dose

    To determine the maximum tolerated dose (MTD) of curcumin, toxicities will be tabulated and reported per dose level according to grade and type of toxicity experienced. The dose level at which no more than 33% of study participants have a DLT will be considered the maximum tolerated dose.

    Up to 22 days after treatment

Secondary Outcomes (2)

  • Toxicity related to treatment

    Up to 22 days after treatment

  • Anoscopy changes

    22 days after treatment

Study Arms (8)

Dose Level 1

EXPERIMENTAL

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

Drug: Curcuminoid Capsules

Dose Level 2

EXPERIMENTAL

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

Drug: Curcuminoid Capsules

Dose Level 3

EXPERIMENTAL

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

Drug: Curcuminoid Capsules

Dose Level 4

EXPERIMENTAL

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

Drug: Curcuminoid Capsules

Dose Level 5

EXPERIMENTAL

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

Drug: Curcuminoid Capsules

Dose Level 6

EXPERIMENTAL

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

Drug: Curcuminoid Capsules

Dose Level 7

EXPERIMENTAL

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

Drug: Curcuminoid Capsules

Dose Level 8

EXPERIMENTAL

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

Drug: Curcuminoid Capsules

Interventions

Curcuminoid CapsulesDRUG

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

Also known as: Curcumin C3 Complex, Curcuma longa (Turmeric)
Dose Level 1Dose Level 2Dose Level 3Dose Level 4Dose Level 5Dose Level 6Dose Level 7Dose Level 8

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Grady Hospital - Ponce De Leon Clinic

Atlanta, Georgia, 30308, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Diarylheptanoidsturmeric extractCurcumin

Intervention Hierarchy (Ancestors)

HeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsHydrocarbons, AromaticHydrocarbons, CyclicCatecholsPhenolsBenzene Derivatives

Study Officials

  • Lisa Flowers, MD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Flowers, MD, MPH

CONTACT

404-251-8931lflowe2@emory.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

March 17, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Deidentified Individual participant data that underlie the published results will be made available for sharing.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be available from December 2025 to January 2031.
Access Criteria
Data will be available for sharing with researchers providing a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to lflowe2@emory.edu. The data requestor needs to sign a data access agreement to gain access.

Locations

US(2)