Safety of Anal Curcumin
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30+
SponsorLisa Flowers
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Curcuminoid Capsules
Treatment groups
48 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Lisa Flowers
Lead sponsor
Emory University
Sponsor institution
Source ClinicalTrials.gov