Anal High Grade Squamous Intraepithelial LesionPhase 1NCT06626230
Safety of Anal Curcumin
A Phase 1 study testing Curcuminoid Capsules in people with Anal High Grade Squamous Intraepithelial Lesion, run by Lisa Flowers at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal High Grade Squamous Intraepithelial Lesion
- What is being tested?
- Curcuminoid Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
- Recruiting
Grady Hospital - Ponce De Leon Clinic
Atlanta, Georgia, 30308
Lisa Flowers, MD
About this study
Official title: An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin
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.
Read the detailed description
This proposal suggests conducting a Phase I clinical trial using a 3 + 3 dose escalation approach to assess the safety and determine the maximum tolerated dose of intra-anal curcumin in individuals with HIV who have anal high-grade squamous intraepithelial lesions (aHSIL/AIN 2-3). Currently, there is a significant need for non-surgical treatments for pre-malignant anal diseases in people with HIV, aiming to reduce risks and complications associated with existing surgical and topical interventions.
Curcumin, a compound derived from turmeric, is known for its anti-inflammatory and anti-infectious properties. While previous research has shown its anticancer effects in oral doses, its bioavailability is limited, and intra-anal administration has not been studied in humans. This trial aims to explore the potential of intra-anal curcumin as an alternative treatment for aHSIL in people with HIV.
The study will involve enrolling participants with aHSIL and administering increasing doses of curcumin intra-anally for 14 days, following the 3 + 3 dose escalation model. The trial will continue until the dose-limiting toxicity (DLT) level is reached, and participants report symptoms necessitating a dose reduction.
To enhance future studies, the researchers will also evaluate patient and male partner acceptability through questionnaires. The insights gained from this trial will guide the design of subsequent efficacy and safety studies for individuals with AIN 2 and 3 neoplasia.
- Being tested
- Curcuminoid Capsules
- Keywords
- HSIL/AIN 2-3, Curcumin, Cancer, Human Papillomavirus (HPV), HIV, Curcuminoids
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcuminoid CapsulesDrug
Also called Curcumin C3 Complex, Curcuma longa (Turmeric)
500 mg curcuminoids from C3 Complex capsule. Curcuma longa (Turmeric), a constituent of the spice turmeric, is considered a low-toxicity, dietary-derived agent with chemopreventive and therapeutic benefits Study participants will be instructed to insert the curcumin capsules gelatin intra-anally every day for a 14-day treatment period.
Escalating doses
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period Receives: Drug: Curcuminoid Capsules |
| Dose Level 2 | Experimental | Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period Receives: Drug: Curcuminoid Capsules |
| Dose Level 3 | Experimental | Participants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period Receives: Drug: Curcuminoid Capsules |
| Dose Level 4 | Experimental | Participants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period Receives: Drug: Curcuminoid Capsules |
| Dose Level 5 | Experimental | Participants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period Receives: Drug: Curcuminoid Capsules |
| Dose Level 6 | Experimental | Participants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period Receives: Drug: Curcuminoid Capsules |
| Dose Level 7 | Experimental | Participants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period Receives: Drug: Curcuminoid Capsules |
| Dose Level 8 | Experimental | Participants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period Receives: Drug: Curcuminoid Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum curcumin tolerated dose
To determine the maximum tolerated dose (MTD) of curcumin, toxicities will be tabulated and reported per dose level according to grade and type of toxicity experienced. The dose level at which no more than 33% of study participants have a DLT will be considered the maximum tolerated dose.
Measured: Up to 22 days after treatment
Secondary outcomes (2)
Toxicity related to treatment
Toxicities will be tabulated and reported per dose level according to grade and type of toxicity experienced (tolerability of curcumin). Participants will be monitored during the trial for adverse events, tolerability, and compliance using the Common Terminology Criteria for Adverse Events (CTCAE). Side effects will be recorded in a study diary maintained by the participant.
Measured: Up to 22 days after treatment
Anoscopy changes
Participants will receive an anoscopy to examine the anus and perineum for any findings outlined in the anoscopic findings chart (Safety of curcumin intra-anal powder)
Measured: 22 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start17 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal High Grade Squamous Intraepithelial LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisa Flowers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisa Flowers, Emory University
- Investigators
- Lisa Flowers, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626230
- Sponsor's protocol ID
- STUDY00007193
- Other IDs
- 2025P011055
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified Individual participant data that underlie the published results will be made available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin
- ClinicalTrials.gov ID
- NCT06626230
- Acronym / sponsor ID
- STUDY00007193
- Keywords
- HSIL/AIN 2-3, Curcumin, Cancer, Human Papillomavirus (HPV), HIV, Curcuminoids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Lisa FlowersUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This proposal suggests conducting a Phase I clinical trial using a 3 + 3 dose escalation approach to assess the safety and determine the maximum tolerated dose of intra-anal curcumin in individuals with HIV who have anal high-grade squamous intraepithelial lesions (aHSIL/AIN 2-3). Currently, there is a significant need for non-surgical treatments for pre-malignant anal diseases in people with HIV, aiming to reduce risks and complications associated with existing surgical and topical interventions.
Curcumin, a compound derived from turmeric, is known for its anti-inflammatory and anti-infectious properties. While previous research has shown its anticancer effects in oral doses, its bioavailability is limited, and intra-anal administration has not been studied in humans. This trial aims to explore the potential of intra-anal curcumin as an alternative treatment for aHSIL in people with HIV.
The study will involve enrolling participants with aHSIL and administering increasing doses of curcumin intra-anally for 14 days, following the 3 + 3 dose escalation model. The trial will continue until the dose-limiting toxicity (DLT) level is reached, and participants report symptoms necessitating a dose reduction.
To enhance future studies, the researchers will also evaluate patient and male partner acceptability through questionnaires. The insights gained from this trial will guide the design of subsequent efficacy and safety studies for individuals with AIN 2 and 3 neoplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: Curcuminoid CapsulesParticipants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period |
| Dose Level 2 | Experimental | Drug: Curcuminoid CapsulesParticipants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period |
| Dose Level 3 | Experimental | Drug: Curcuminoid CapsulesParticipants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period |
| Dose Level 4 | Experimental | Drug: Curcuminoid CapsulesParticipants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period |
| Dose Level 5 | Experimental | Drug: Curcuminoid CapsulesParticipants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period |
| Dose Level 6 | Experimental | Drug: Curcuminoid CapsulesParticipants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period |
| Dose Level 7 | Experimental | Drug: Curcuminoid CapsulesParticipants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period |
| Dose Level 8 | Experimental | Drug: Curcuminoid CapsulesParticipants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcuminoid CapsulesAlso: Curcumin C3 Complex, Curcuma longa (Turmeric)500 mg curcuminoids from C3 Complex capsule. Curcuma longa (Turmeric), a constituent of the spice turmeric, is considered a low-toxicity, dietary-derived agent with chemopreventive and therapeutic benefits Study participants will be instructed to insert the curcumin capsules gelatin intra-anally every day for a 14-day treatment period. Escalating doses | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7, Dose Level 8 |
Primary outcome
Maximum curcumin tolerated dose
Time frame: Up to 22 days after treatment
To determine the maximum tolerated dose (MTD) of curcumin, toxicities will be tabulated and reported per dose level according to grade and type of toxicity experienced. The dose level at which no more than 33% of study participants have a DLT will be considered the maximum tolerated dose.
2 secondary outcomes
Toxicity related to treatment
Time frame: Up to 22 days after treatment
Anoscopy changes
Time frame: 22 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified Individual participant data that underlie the published results will be made available for sharing.
Related trials for Anal High Grade Squamous Intraepithelial Lesion
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Active, not recruiting
Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico
AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma
Active, not recruitingObservational study
Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)
Human Immunodeficiency Virus, Human Papillomavirus-Related Anal Squamous Cell Carcinoma
Not yet recruitingPhase 1
Use of ACU-D1 in HPV Associated Vulvar and Perianal Lesions in People With HIV
Human Papilloma Virus, Human Immunodeficiency Virus
Recruiting
Screening for Anal Cancer in Men Who Have Sex With Men Using Pre-Exposure Prophylaxis
Anal Cancer, Squamous Intraepithelial Lesions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Flowers, MD, MPH principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Curcuminoid Capsules in people with Anal High Grade Squamous Intraepithelial Lesion, run by Lisa Flowers at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Flowers, MD, MPH (404-251-8931, lflowe2@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum curcumin tolerated dose (time frame: Up to 22 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.