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Anti-malarial agent

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

Phase 2
Waitlist Available
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
Anal high grade intraepithelial neoplasia
Must not have
Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA
Concurrent anal, vulvar, cervical, or penile cancer
Timeline
Screening 6 weeks
Treatment 7 weeks
Follow Up 11 weeks

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.
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).
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a high-grade precancerous condition in my anal area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a low-grade anal precancerous condition without any high-grade lesions.
Select...
I do not have anal, vulvar, cervical, or penile cancer.
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I am HIV positive.
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I am not currently undergoing chemotherapy or radiation for another cancer.
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I am currently taking medication that weakens my immune system.
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I am not taking strong medications that affect liver enzyme activity.
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I am using imiquimod or 5-FU during the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of subjects with complete and partial response by week 18
Secondary study objectives
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 study objectives
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%
Otitis media
8%
Abdominal pain
7%
Thrombocytopenia
6%
Excoriation
6%
Thermal burn
6%
Rash pruritic
5%
Parotitis
5%
Helminthic infection
5%
Oral herpes
4%
Stomatitis
4%
Alanine aminotransferase increased
3%
Pruritus
3%
Vomiting
1%
Febrile convulsion
1%
Bronchitis
1%
Rectal prolapse
1%
Pneumonia primary atypical
1%
Neutropenia
1%
Malnutrition
1%
Conjunctivitis bacterial
1%
Inguinal hernia
1%
Malaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chloroquine Plus Artesunate
Chloroquine Plus Atovaquone-Proguanil
CQ Plus Azithromycin
CQ Monotherapy

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
University of California, San FranciscoOTHER
2,591 Previous Clinical Trials
14,901,586 Total Patients Enrolled
Frantz Viral Therapeutics, LLCLead Sponsor
5 Previous Clinical Trials
186 Total Patients Enrolled
Joel Palefsky, MDPrincipal InvestigatorUniversity of California, San Francisco
9 Previous Clinical Trials
6,810 Total Patients Enrolled

Media Library

Human Papillomavirus Clinical Trial 2023: Artesunate Highlights & Side Effects. Trial Name: NCT05555862 — Phase 2
~0 spots leftby Dec 2024
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