Health TrialsbyHealthPanel

Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

ConditionsAnal High-grade Squamous Intraepithelial LesionAnal HSILAnal HPV InfectionAIN
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrantz Viral Therapeutics, LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men and women age ≥ 18 years

Capable of informed consent

Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA.

Positive anal human papillomavirus (HPV) test.

Disqualifiers

Pregnant and nursing women

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

HIV-seropositivity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artesunate ointment

    Drug

    Four 5-day cycles of artesunate ointment given at weeks 0, 2, 4, 6

  • Placebo

    Drug

    Four 5-day cycles of placebo ointment given at weeks 0, 2, 4, 6

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: ArtesunateExperimental treatment 1 intervention
Group B: Placebo ointmentPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete and partial response by week 18

Number of participants with complete and partial response after four 5-day cycles of artesunate ointment

Time frame
18 weeks

Secondary outcomes

1

HPV clearance

Number of participants who do not have detectable HPV infection

Time frame
42 weeks
2

Complete and partial response after week 18

Number of participants with complete and partial response after week 18

Time frame
30 weeks
3

Complete and partial peri-anal response after intra-anal ointment application

Number of participants who have complete and partial peri-anal response after 4 5-day cycles of intra-anal ointment

Time frame
42 weeks
4

Persistence of response

Number of participants who have complete response and do not have recurrence of anal HSIL

Time frame
42 weeks

Other outcomes

1

Safety of intra-anal artesunate ointment

Number of participants who do not have any drug-related serious adverse events

Time frame
42 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Frantz Viral Therapeutics, LLC

Lead sponsor

Laser Surgery Care, LLC

Collaborator

Anal Dysplasia Clinic MidWest

Collaborator

Source ClinicalTrials.gov
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