Safety of Anal Curcumin
Recruiting · NCT06626230 · Interventional (participants receive a specific treatment) · Lead sponsor: Lisa Flowers
View the official record on ClinicalTrials.gov →Interventions studied
Curcuminoid Capsules
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.
Who can take part
Age range
30 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed across 1 US state.
- Grady Memorial Hospital - Atlanta, Georgia, United States
- Grady Hospital - Ponce De Leon Clinic - Atlanta, Georgia, United States