Topical treatment for anal high-grade lesions in HIV-negative individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the efficacy of artesunate ointment in treating anal high-grade squamous intraepithelial lesions (HSIL) in HIV-negative adults. Participants are randomly assigned to receive either the artesunate ointment or a placebo over four 5-day cycles, with follow-up assessments using anoscopy at specified intervals. The primary goal is to assess the histopathologic response to the treatment, while secondary objectives include evaluating viral clearance and safety. Non-responders will receive standard care ablation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Women of childbearing potential agree to use birth control for the duration of the study.
* Laboratory values at Screening of:

  1. Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN)
  2. Serum aspartate transaminase (SGOT/AST) \< 5 x ULN
  3. Serum Bilirubin (total) \< 2.5 x ULN
  4. Serum Creatinine ≤ 1.5 x ULN
* Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
* Weight ≥ 50kg

Exclusion Criteria:

* 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
* Currently receiving systemic chemotherapy or radiation therapy for another cancer.
* Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease). Participants using nasal steroid treatments for allergic conditions may participate in the study.
* Concomitant use of strong UGT (Uridine-diphosphate-glucuronosyltransferase) inhibitors
* Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study

Where it's running

• Anal Dysplasia Clinic MidWest
  Chicago, Illinois, United States Recruiting
• Laser Surgery Care
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Mihaela Plesa
• Email: fvtinfo@frantzgroup.com
• Phone: 440-255-1155

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Probiotics to Treat Anal HSIL in HIV Patients

  In people with HIV who have anal HSIL, this study tests whether a probiotic called EXE-346 can help clear lesions or reduce progression, compared with placebo.

  Recruiting Phase 2 University of California, San Francisco · San Francisco, California and 1 other locations · NCT06949800

• Using curcumin to treat anal high-grade lesions in HIV patients

  This study is testing whether curcumin, a natural compound, can safely treat anal high-grade lesions in people with HIV without the side effects of surgery.

  Recruiting at 2 sites Phase 1 Emory University · Atlanta, Georgia and 1 other locations · NCT06626230

• NWRD08 for HPV‑16/18‑related cervical HSIL (CIN2/3)

  This trial tests whether injections of NWRD08 given with electroporation can help women aged 18–60 who have HPV‑16 or HPV‑18 positive cervical high‑grade lesions (CIN2 or CIN3).

  Recruiting at 5 sites Phase 2 Newish Biotech (Wuxi) Co., Ltd. · Beijing, Beijing Municipality and 4 other locations · NCT07175662

• NWRD09 mRNA vaccine for HPV16-related cervical HSIL

  This Phase 1 study will try an mRNA vaccine called NWRD09 to see if it is safe and triggers immune responses in people with HPV16-related cervical HSIL.

  Recruiting Phase 1 Newish Biotech (Wuxi) Co., Ltd. · Beijing · NCT07047989

• ALA-PDT vs LEEP for cervical HSIL/CIN2: a multicenter non-randomized comparison

  This study tests whether a non-surgical photodynamic therapy (ALA-PDT) can match the effectiveness of LEEP for HSIL/CIN2 in women.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang and 4 other locations · NCT07306260

• Pap smear versus a three-marker blood test to find cervical precancer and cancer

  This tests whether a blood test that measures three molecular markers can find cervical precursor lesions and cancer as well as the Pap smear in women 18 to 85.

  Recruiting Timser SAPI de CV · Mexico City, Mexico City · NCT07480902

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.