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Anti-metabolites

Artesunate Vaginal Inserts for Cervical Dysplasia (ART-CIN_IIB Trial)

Phase 2
Recruiting
Research Sponsored by Frantz Viral Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential agree to use birth control through week 28 of the study.
Are you at least 110 pounds?
Must not have
Are you immune compromised in any way?
Are you pregnant or breastfeeding?
Timeline
Screening 6 weeks
Treatment 5 weeks
Follow Up 6 months
Awards & highlights

ART-CIN_IIB Trial Summary

This trial is testing a vaginal insert containing Artesunate for the treatment of CIN2/3 in women. The insert will be compared to a placebo insert to see if it is effective.

Who is the study for?
This trial is for adult women aged 25 or older with a biopsy-confirmed diagnosis of high-grade cervical lesions (CIN2/3), weighing at least 50kg, and not pregnant or breastfeeding. Participants must be able to consent and agree to use birth control until week 28 of the study. Women who are immunocompromised, have concurrent cancer (except nonmelanoma skin lesions), HIV-seropositive, or have active autoimmune diseases cannot join.Check my eligibility
What is being tested?
The study is testing Artesunate vaginal inserts versus placebo inserts in treating high-grade cervical pre-cancerous lesions caused by HPV. It's a phase II trial where participants are randomly assigned to receive either the treatment or placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects for Artesunate vaginal inserts aren't listed here, similar treatments may cause local irritation, discomfort, mild allergic reactions, or systemic effects if absorbed at higher levels.

ART-CIN_IIB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to use birth control until week 28 of the study.
Select...
I weigh at least 110 pounds.
Select...
I am a woman aged 25 or older.
Select...
I have been diagnosed with high grade cervical lesions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

ART-CIN_IIB Trial Timeline

Screening ~ 6 weeks
Treatment ~ 5 weeks
Follow Up ~6 months
This trial's timeline: 6 weeks for screening, 5 weeks for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants with histologic regression by week 17
Secondary outcome measures
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure.
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17
Other outcome measures
Number of participants who withdrew from the study due to TEAEs
Number of participants with Treatment-Emergent Adverse Events (TEAE)

ART-CIN_IIB Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Artesunate vaginal insertExperimental Treatment1 Intervention
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Group II: Placebo vaginal insertsPlacebo Group1 Intervention
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.

Find a Location

Who is running the clinical trial?

Morehouse School of MedicineOTHER
20 Previous Clinical Trials
16,073 Total Patients Enrolled
Frantz Viral Therapeutics, LLCLead Sponsor
5 Previous Clinical Trials
156 Total Patients Enrolled
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,604 Total Patients Enrolled

Media Library

Artesunate (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04098744 — Phase 2
Human Papillomavirus Research Study Groups: Placebo vaginal inserts, Artesunate vaginal insert
Human Papillomavirus Clinical Trial 2023: Artesunate Highlights & Side Effects. Trial Name: NCT04098744 — Phase 2
Artesunate (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098744 — Phase 2
Human Papillomavirus Patient Testimony for trial: Trial Name: NCT04098744 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being accepted for this experiment?

"Yes. The clinical trial is recruiting for 78 patients across 8 locations, as indicated on the website clinicaltrials.gov. This information was last updated on 9/12/2022, and the trial was initially posted on 9/9/2020."

Answered by AI

What is the clinical efficacy of Artesunate vaginal insert?

"Artesunate vaginal insert was first studied in the year 2017 at University Hospitals of Derby and Burton NHS Foundation Trust. Since then there have been 118 completed studies with 12 clinical trials currently recruiting patients. Many of these studies are being performed out of Ann Arbor, Michigan."

Answered by AI

What are the goals that researchers hope to achieve with this clinical trial?

"The primary outcome of this trial, which will be measured over a 15 week time frame is the Proportion of participants with histologic regression by week 17. Secondary outcomes include: the Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17, defined as the Number of participants who had HPV strains detected at study entry which become undetectable by week 17; the Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure, defined as the Number of participants who had HPV"

Answered by AI

How many people are currently a part of this research project?

"That is correct. Based on the information available from clinicaltrials.gov, this specific trial is searching for patients and was last updated September 12th, 2022. They are looking for 78 people total across 8 sites."

Answered by AI

What is the FDA's stance on Artesunate vaginal insert?

"Although there is lack of data regarding Artesunate vaginal insert's efficacy, it has been determined to be safe in Phase 2 trials. Consequently, our team gives it a safety rating of 2."

Answered by AI

Is this research project open to applicants who are still young?

"In order to participate in this clinical trial, applicants must be aged 25-100. There are a total of 34 studies for patients under 18 and 102 for those over 65 years old."

Answered by AI

At how many hospitals or other medical facilities is this research being conducted?

"Patients can enroll at 8 different locations including Ann Arbor, Brightwaters and Mayfield Heights. The other enrolment centres are located near these cities. If you decide to participate in this trial, try to select the closest location to minimize travel time and expenses."

Answered by AI

Might I be able to enroll in this particular clinical trial?

"This study is recruiting 78 people with immunoglobulin g4-related disease between the ages of 25 and 100. Most notable, patients must meet the following criteria: Adult females age ≥ 25 years, Capable of informed consent, Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3), Women of childbearing potential agree to use birth control through week 28 of the study., Weight ≥ 50kg, Any HPV genotype detectable by DNA test/HPV genotyping."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Georgia
Ohio
What site did they apply to?
Cleveland Clinic Fairview Hospital
Other
Grady Health System
Hillcrest Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Worried about cervical cancer. Had my second Leep and first conization. I haven't tried anything but I'm sick everyday.
PatientReceived 2+ prior treatments
Ok maybe I don’t qualify I have herpes complex. I want to address this condition before it kills me.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

When can I start?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Cleveland Clinic Fairview Hospital: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
~5 spots leftby Jul 2024