Using curcumin to treat anal high-grade lesions in HIV patients
Official title: An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin
Run by Emory University · NCT06626230 · Data updated 2026-11-12
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 |
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT06626230 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 30 and older with biopsy-proven aHSIL who have not received prior treatment.
✕Probably not a fit
Patients with a history of anal cancer or significant chronic medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While curcumin has shown anticancer effects in other contexts, this specific approach of intra-anal administration has not been previously tested in humans.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Topical treatment for anal high-grade lesions in HIV-negative individuals
This study is testing if an ointment called artesunate can help treat anal high-grade lesions in HIV-negative adults better than a placebo.
-
NWRD08 for HPV‑16/18‑related cervical HSIL (CIN2/3)
This trial tests whether injections of NWRD08 given with electroporation can help women aged 18–60 who have HPV‑16 or HPV‑18 positive cervical high‑grade lesions (CIN2 or CIN3).
-
NWRD09 mRNA vaccine for HPV16-related cervical HSIL
This Phase 1 study will try an mRNA vaccine called NWRD09 to see if it is safe and triggers immune responses in people with HPV16-related cervical HSIL.
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ALA-PDT vs LEEP for cervical HSIL/CIN2: a multicenter non-randomized comparison
This study tests whether a non-surgical photodynamic therapy (ALA-PDT) can match the effectiveness of LEEP for HSIL/CIN2 in women.
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Probiotics to Treat Anal HSIL in HIV Patients
In people with HIV who have anal HSIL, this study tests whether a probiotic called EXE-346 can help clear lesions or reduce progression, compared with placebo.
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Pap smear versus a three-marker blood test to find cervical precancer and cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.