Artesunate suppositories for human papillomavirus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
human papillomavirus+9 More
Artesunate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • human papillomavirus
  • AIN 2/3
  • Anus Diseases
  • Anal Precancerous Condition
  • Anal Intraepithelial Neoplasia (AIN)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 42 weeks

12 weeks
Number of participants who withdrew from the study due to TEAEs
Therapeutic procedure
18 weeks
Number of subjects with complete and partial response by week 18
30 weeks
Number of participants with complete and partial response after week 18 but over the study window
42 weeks
Changes in physical examination abnormalities
Body Weight Changes
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
8 weeks
Electrocardiogram

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

CQ Plus Azithromycin
75%Nasopharyngitis
21%Gastroenteritis
20%Pruritus
20%Haemorrhagic anaemia
19%Conjunctivitis
19%Impetigo
18%Pneumonia
18%Cough
18%Pyrexia
16%Diarrhoea
13%Rash papular
13%Helminthic infection
10%Abdominal pain
9%Tinea capitis
8%Dysentery
7%Vomiting
7%Otitis media
6%Body tinea
6%Alanine aminotransferase increased
5%Neutropenia
4%Thrombocytopenia
4%Conjunctivitis bacterial
4%Excoriation
3%Stomatitis
3%Varicella
3%Rash pruritic
3%Thermal burn
3%Parotitis
3%Bronchitis
1%Malaria
1%Limb discomfort
1%Laceration
1%Oral herpes
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT00379821) in the CQ Plus Azithromycin ARM group. Side effects include: Nasopharyngitis with 75%, Gastroenteritis with 21%, Pruritus with 20%, Haemorrhagic anaemia with 20%, Conjunctivitis with 19%.

Trial Design

2 Treatment Groups

Artesunate suppositories
1 of 2
Placebo suppositories
1 of 2
Experimental Treatment
Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Artesunate suppositories · Has Placebo Group · Phase 2

Artesunate suppositories
Drug
Experimental Group · 1 Intervention: Artesunate · Intervention Types: Drug
Placebo suppositories
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Artesunate
2005
Completed Phase 4
~3930

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 42 weeks

Who is running the clinical trial?

Frantz Viral Therapeutics, LLCLead Sponsor
3 Previous Clinical Trials
111 Total Patients Enrolled
Amarex CROUNKNOWN
University of California, San FranciscoOTHER
2,262 Previous Clinical Trials
11,470,056 Total Patients Enrolled
Laser Surgery CareOTHER
2 Previous Clinical Trials
495 Total Patients Enrolled
Anal Dysplasia Clinic MidWestUNKNOWN
Joel Palefsky, MDPrincipal InvestigatorUniversity of California, San Francisco
8 Previous Clinical Trials
8,223 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a serum creatinine of at least 1.5 x ULN.
You have an ECG with no clinically significant findings as assessed by the Investigator.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.