HPV-Related Anal Intraepithelial NeoplasiaPhase 1ART-AINNCT03100045
Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
A Phase 1 study testing Artesunate Suppositories in people with HPV-Related Anal Intraepithelial Neoplasia and AIN2/3, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HPV-Related Anal Intraepithelial Neoplasia, AIN2/3, Artesunate
- What is being tested?
- Artesunate Suppositories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2017to 6 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy (HRA)
- Female of childbearing potential: negative urine pregnancy test
- Able to provide informed consent
- Patients who have the ability to collaborate with planned follow-up (transportation, compliance history, etc.).
- Weight ≥50 kg.
Who cannot join
- Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by high resolution anoscopy
- Known anal, vulvar, cervical, or penile cancer
- CD4 count < 200 at the time of consideration for entry into this study
- Unable to provide informed consent
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease)
- Extensive anal condyloma precludes the ability for the clinician to visualize HSIL during HRA
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
Read the detailed description
Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving different doses of Artesunate suppositories administered trans-anally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1 cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.
- Conditions
- HPV-Related Anal Intraepithelial Neoplasia, AIN2/3, Artesunate, Alternative Treatment, Anal Dysplasia, Precancerous Conditions
- Being tested
- Artesunate Suppositories
- Keywords
- HPV, suppository, Artesunate, artemisinin, anal dysplasia, treatment, alternative treatment, anal precancer, Johns Hopkins, Sandy Fang, Frantz Viral Therapeutics, Wisconsin, Evie Carchman
- Medical subject headings
- Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate SuppositoriesDrug
Also called Artemisinin
Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
| Study group | Role | What they receive |
|---|---|---|
| ART 200 mg, 2 cycles | Experimental | Two five-day cycles of Artesunate suppositories, 200 mg/day Receives: Drug: Artesunate Suppositories |
| ART 200 mg, 3 cycles | Experimental | Three five-day cycles of Artesunate suppositories, 200 mg/day Receives: Drug: Artesunate Suppositories |
| ART 400 mg, 2 cycles | Experimental | Two five-day cycles of Artesunate suppositories, 400 mg/day Receives: Drug: Artesunate Suppositories |
| ART 400 mg, 3 cycles | Experimental | Three five-day cycles of Artesunate suppositories, 400 mg/day Receives: Drug: Artesunate Suppositories |
| ART 600 mg, 2 cycles | Experimental | Two five-day cycles of Artesunate suppositories, 600 mg/day Receives: Drug: Artesunate Suppositories |
| ART 600 mg, 3 cycles | Experimental | Three five-day cycles of Artesunate suppositories, 600 mg/day Receives: Drug: Artesunate Suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3)
Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0
Measured: 6 weeks from the date of the first dosing
Secondary outcomes (3)
Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less
Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy
Measured: 16 weeks
Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less
Number of patients with no AIN2/3 as assessed by high resolution anoscopy and biopsy
Measured: 28 weeks
Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping
Number of patients with HPV genotypes present at study entry which become undetectable during the study window
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start20 Apr 2017
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Related Anal Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Model description
- Subjects will be enrolled sequentially in each treatment cohort.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Frantz Viral Therapeutics, LLC, University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Sandy H Fang, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100045
- Sponsor's protocol ID
- IRB00090922
- Acronym
- ART-AIN
- Status last verified
- Nov 2021
- First submitted
- 29 Mar 2017
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
- ClinicalTrials.gov ID
- NCT03100045
- Acronym / sponsor ID
- ART-AIN / IRB00090922
- Conditions
- HPV-Related Anal Intraepithelial Neoplasia, AIN2/3, Artesunate, Alternative Treatment, Anal Dysplasia, Precancerous Conditions
- Keywords
- HPV, suppository, Artesunate, artemisinin, anal dysplasia, treatment, alternative treatment, anal precancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Frantz Viral Therapeutics, LLC, University of Wisconsin, Madison
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 4 Apr 2017 (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.
This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
Detailed description
Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving different doses of Artesunate suppositories administered trans-anally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1 cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Subjects will be enrolled sequentially in each treatment cohort.
| Arm | Type | Receives |
|---|---|---|
| ART 200 mg, 2 cycles | Experimental | Drug: Artesunate SuppositoriesTwo five-day cycles of Artesunate suppositories, 200 mg/day |
| ART 200 mg, 3 cycles | Experimental | Drug: Artesunate SuppositoriesThree five-day cycles of Artesunate suppositories, 200 mg/day |
| ART 400 mg, 2 cycles | Experimental | Drug: Artesunate SuppositoriesTwo five-day cycles of Artesunate suppositories, 400 mg/day |
| ART 400 mg, 3 cycles | Experimental | Drug: Artesunate SuppositoriesThree five-day cycles of Artesunate suppositories, 400 mg/day |
| ART 600 mg, 2 cycles | Experimental | Drug: Artesunate SuppositoriesTwo five-day cycles of Artesunate suppositories, 600 mg/day |
| ART 600 mg, 3 cycles | Experimental | Drug: Artesunate SuppositoriesThree five-day cycles of Artesunate suppositories, 600 mg/day |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy (HRA)
- Female of childbearing potential: negative urine pregnancy test
- Able to provide informed consent
- Patients who have the ability to collaborate with planned follow-up (transportation, compliance history, etc.).
Key exclusion criteria (7 listed)
- Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by high resolution anoscopy
- Known anal, vulvar, cervical, or penile cancer
- CD4 count < 200 at the time of consideration for entry into this study
- Unable to provide informed consent
- Currently receiving systemic chemotherapy or radiation therapy for another cancer.
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 |
|---|---|---|
| Artesunate SuppositoriesAlso: ArtemisininArtesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia | Drug | ART 200 mg, 2 cycles, ART 200 mg, 3 cycles, ART 400 mg, 2 cycles, ART 400 mg, 3 cycles, ART 600 mg, 2 cycles, ART 600 mg, 3 cycles |
Primary outcome
Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3)
Time frame: 6 weeks from the date of the first dosing
Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0
3 secondary outcomes
Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less
Time frame: 16 weeks
Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less
Time frame: 28 weeks
Number of patients with viral clearance of human papillomavirus (HPV) virus measured by HPV genotyping
Time frame: 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sandy H Fang, MD principal investigator
Johns Hopkins 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 Artesunate Suppositories in people with HPV-Related Anal Intraepithelial Neoplasia and AIN2/3, run by Johns Hopkins University 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 6 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: finished, as of the sponsor's last update on 3 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3) (time frame: 6 weeks from the date of the first dosing). 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 3 Nov 2021.