Using curcumin to treat anal high-grade lesions in HIV patients
An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin
This study is testing whether curcumin, a natural compound, can safely treat anal high-grade lesions in people with HIV without the side effects of surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06626230 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and maximum tolerated dose of intra-anal curcumin in individuals living with HIV who have anal high-grade squamous intraepithelial lesions (aHSIL). Utilizing a 3 + 3 dose escalation approach, participants will receive increasing doses of curcumin for 14 days. The study seeks to provide a non-surgical alternative to current treatments, which can have significant side effects. Additionally, patient acceptability will be assessed through questionnaires to inform future studies.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 and older with biopsy-proven aHSIL who have not received prior treatment.
Not a fit: Patients with a history of anal cancer or significant chronic medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer, non-surgical option for managing precancerous anal lesions in HIV-positive patients.
How similar studies have performed: While curcumin has shown anticancer effects in other contexts, this specific approach of intra-anal administration has not been previously tested in humans.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
- Grady Hospital - Ponce De Leon Clinic — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Flowers, MD, MPH — Emory University
- Study coordinator: Lisa Flowers, MD, MPH
- Email: lflowe2@emory.edu
- Phone: 404-251-8931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.