BridgeMD
Tests treatment safety and results for Anal High Grade Squamous Intraepithelial Lesion
Official title Safety of Anal Curcumin
ClinicalTrials.gov ID: NCT06626230
What this study is testing
What is Curcuminoid Capsules?
Curcuminoid Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anal high grade squamous intraepithelial lesion.
Also referred to as Curcumin C3 Complex, Curcuma longa (Turmeric).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older. Healthy volunteers may be eligible.
You may be able to join if
- Major
- 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
You likely can't join if
- Have a clinically significant chronic medical condition that is considered progressive, such as but not limited to coronary disease, congestive heart...
- 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.
See the full eligibility criteria
- Major
- 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 apply
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.