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Anti-malarial agent

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

Q: What are the risks associated with using Artesunate suppositories?

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

Q: Can people currently sign up to participate in this research?

<p>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.</p>

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

Be older than 18 years old

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

anal HSIL HIV- Trial Timeline

Screening ~ 6 weeks1 visit

Treatment ~ 7 weeks1 visit

Follow Up ~ 11 weeks4 visits

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

Body tinea

Otitis media

Abdominal pain

Thrombocytopenia

Excoriation

Thermal burn

Rash pruritic

Helminthic infection

Parotitis

Oral herpes

Stomatitis

Alanine aminotransferase increased

Pruritus

Vomiting

Neutropenia

Bronchitis

Rectal prolapse

Pneumonia primary atypical

Malnutrition

Febrile convulsion

Conjunctivitis bacterial

Inguinal hernia

Malaria

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL

2023. "Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05555862.

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