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

NCT05555862 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-05-18

No results posted yet for this study

Summary

This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)

Conditions

  • Anal High Grade Squamous Intraepithelial Lesion
  • Anal Precancerous Condition
  • AIN 2/3
  • HPV Infection
  • Anal Dysplasia
  • HPV Disease

Interventions

DRUG

Artesunate

artesunate formulated as intra-anal suppositories

DRUG

Placebo

placebo intra-anal suppository

Sponsors & Collaborators

  • Amarex CRO

    collaborator UNKNOWN

  • University of California, San Francisco

    collaborator OTHER

  • Anal Dysplasia Clinic MidWest

    collaborator UNKNOWN

  • Laser Surgery Care

    collaborator OTHER

  • Frantz Viral Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Joel Palefsky, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-10
Primary Completion
2026-12-28
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555862 on ClinicalTrials.gov