Study on Artesunate Vaginal Inserts for Treating Cervical Pre-Cancerous Lesions (CIN2/3)

Sponsor: Frantz Viral Therapeutics, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04098744

Provider View

This clinical trial is testing the effectiveness and safety of artesunate vaginal inserts for women with high-grade cervical pre-cancerous lesions, known as CIN2/3. The study compares artesunate to a placebo to see if it can help clear the virus and improve cervical health.

Patient Parameters

Program Overview

This study is investigating whether artesunate vaginal inserts can effectively treat high-grade cervical pre-cancerous lesions (CIN2/3) in women. Participants will be randomly assigned to receive either artesunate or a placebo. The treatment involves using the inserts for three 5-day cycles over several weeks. The study will monitor participants' health and the treatment's impact on the virus and cervical lesions.

Description

In this study, women with high-grade cervical pre-cancerous lesions (CIN2/3) will be randomly assigned to receive either artesunate or a placebo vaginal insert. The treatment consists of three 5-day cycles, administered at weeks 0, 2, and 4. Participants can receive their medication through telehealth, with the inserts mailed to their homes. Follow-up visits will occur at weeks 6, 17, and 40 to monitor progress. All participants will undergo a LEEP procedure, a standard treatment for removing abnormal cervical tissue, at week 17.

The main goal is to see how well the artesunate inserts work in reducing the cervical lesions. The study will also assess the safety of the treatment and its ability to clear the virus associated with these lesions. By comparing the results between the artesunate and placebo groups, researchers aim to determine the effectiveness of artesunate in treating CIN2/3.

Eligibility Criteria

Inclusion Criteria

  • Women aged 25 years or older.
  • Able to provide informed consent.
  • Have any type of HPV detectable by a DNA test.
  • Have a confirmed diagnosis of high-grade cervical lesions (CIN2, CIN3, or CIN2/3) through a biopsy.
  • Women who can become pregnant must agree to use birth control until week 17 of the study.
  • Weigh at least 50 kg (about 110 pounds).

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have an active autoimmune disease.
  • Are taking medications that suppress the immune system.
  • Are HIV positive.
  • Have a weakened immune system.
  • Have evidence of cervical adenocarcinoma in situ (a type of cervical cancer).
  • Have another type of cancer, except for nonmelanoma skin lesions, due to potential effects from other cancer treatments.

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