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Anti-malarial agent

Artesunate suppositories for anal HSIL (anal HSIL HIV- Trial)

Phase 2
Recruiting
Led By Joel Palefsky, MD
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
Laboratory values at Screening of: Serum alanine transaminase (SGPT/ALT) < 5 x upper limit of normal (ULN), Serum aspartate transaminase (SGOT/AST) < 5 x ULN, Serum Bilirubin (total) < 2.5 x ULN, Serum Creatinine ≤ 1.5 x ULN, Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator., Weight ≥ 50kg
Adult men and women age ≥ 18 years
Timeline
Screening 6 weeks
Treatment 7 weeks
Follow Up 11 weeks
Awards & highlights

anal HSIL HIV- Trial Summary

This trial is testing whether Artesunate suppositories can treat anal HSIL in people who are HIV-negative.

Who is the study for?
This trial is for HIV-negative adults over 18 with a specific type of anal lesion called high-grade squamous intraepithelial lesions (HSIL). They must have normal liver and kidney function, weigh at least 50kg, and women must use birth control. People with low-grade dysplasia only, HIV, other cancers being treated, or on strong immune system suppressants can't join.Check my eligibility
What is being tested?
The study tests Artesunate suppositories against placebo in treating anal HSIL. It's a phase II trial where participants are randomly assigned to either the treatment or placebo group without knowing which one they receive (double-blind).See study design
What are the potential side effects?
While not specified here, Artesunate may cause side effects like headaches, dizziness, anemia (low red blood cell count), and gastrointestinal issues such as nausea or diarrhea.

anal HSIL HIV- Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I understand the details of the clinical trial and can give my consent.
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I have a confirmed high-grade anal lesion.
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I agree to use birth control throughout the study.

anal HSIL HIV- Trial Timeline

Screening ~ 6 weeks
Treatment ~ 7 weeks
Follow Up ~11 weeks
This trial's timeline: 6 weeks for screening, 7 weeks for treatment, and 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with complete and partial response by week 18
Secondary outcome measures
Artesunate
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) over the study window
Number of participants who undergo complete response who maintain their response over the study window
+1 more
Other outcome measures
Changes in physical examination abnormalities
Body Weight Changes
Electrocardiogram
+2 more

Side effects data

From 2012 Phase 3 trial • 640 Patients • NCT00379821
80%
Nasopharyngitis
29%
Impetigo
29%
Gastroenteritis
26%
Diarrhoea
23%
Pneumonia
19%
Pyrexia
17%
Conjunctivitis
16%
Haemorrhagic anaemia
16%
Cough
14%
Tinea capitis
11%
Dysentery
11%
Varicella
11%
Rash papular
9%
Body tinea
8%
Abdominal pain
8%
Otitis media
7%
Thrombocytopenia
6%
Excoriation
6%
Thermal burn
6%
Rash pruritic
5%
Helminthic infection
5%
Parotitis
5%
Oral herpes
4%
Stomatitis
4%
Alanine aminotransferase increased
3%
Pruritus
3%
Vomiting
1%
Bronchitis
1%
Neutropenia
1%
Rectal prolapse
1%
Malnutrition
1%
Febrile convulsion
1%
Conjunctivitis bacterial
1%
Inguinal hernia
1%
Malaria
1%
Pneumonia primary atypical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chloroquine Plus Artesunate
Chloroquine Plus Atovaquone-Proguanil
CQ Plus Azithromycin
CQ Monotherapy

anal HSIL HIV- Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Artesunate suppositoriesExperimental Treatment1 Intervention
Four 5-day cycles of artesunate suppositories
Group II: Placebo suppositoriesPlacebo Group1 Intervention
Four 5-day cycles of placebo suppositories
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Artesunate
2005
Completed Phase 4
~3930

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Anal Dysplasia Clinic MidWestUNKNOWN
1 Previous Clinical Trials
48 Total Patients Enrolled
Laser Surgery CareOTHER
2 Previous Clinical Trials
495 Total Patients Enrolled
Amarex CROUNKNOWN

Media Library

Human Papillomavirus Clinical Trial 2023: Artesunate Highlights & Side Effects. Trial Name: NCT05555862 — Phase 2

Frequently Asked Questions

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

What are the risks associated with using Artesunate suppositories?

"Artesunate suppositories have only been tested in Phase 2 trials, so there is some data supporting safety but not efficacy."

Answered by AI

Can people currently sign up to participate in this research?

"The information available on clinicaltrials.gov suggests that this medical trial is not presently looking for participants. This particular study was originally posted on November 15th, 2022 and was most recently edited on November 7th, 2022. Although this specific trial isn't searching for patients at the moment, there are 887 other trials that are currently doing so."

Answered by AI
~0 spots leftby Feb 2024