An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: t
View:
• 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
Locations
United States
Georgia
Grady Hospital - Ponce De Leon Clinic
RECRUITING
Atlanta
Grady Memorial Hospital
RECRUITING
Atlanta
Contact Information
Primary
Lisa Flowers, MD, MPH
lflowe2@emory.edu
404-251-8931
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2026-01
Participants
Target number of participants: 48
Treatments
Experimental: Dose Level 1
Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period
Experimental: Dose Level 2
Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period
Experimental: Dose Level 3
Participants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period
Experimental: Dose Level 4
Participants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period
Experimental: Dose Level 5
Participants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period
Experimental: Dose Level 6
Participants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period
Experimental: Dose Level 7
Participants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period
Experimental: Dose Level 8
Participants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period
Related Therapeutic Areas
Sponsors
Leads: Lisa Flowers