Imiquimod vs. Fluorouracil for Anal Lesions in HIV/AIDS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, imiquimod and fluorouracil, to evaluate their effectiveness compared to no treatment for high-grade anal lesions in HIV-positive individuals. Imiquimod boosts the immune system to fight tumor cells, while fluorouracil, a chemotherapy drug, stops tumor cells from growing. The trial seeks HIV-positive individuals diagnosed with high-grade squamous lesions in the anal area. Participants should be able to apply the treatment themselves and must not have a history of anal cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anticoagulants (except aspirin or NSAIDs) or certain immune system therapies. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both imiquimod and fluorouracil are generally safe for treating anal lesions in people with HIV. Studies have found that imiquimod is a safe option for treating anal high-grade squamous intraepithelial lesions (HSIL), especially in HIV-positive men. It boosts the immune system to help fight off abnormal cells.
Fluorouracil, a type of chemotherapy, helps stop the growth of tumor cells. Research has shown that many HIV-positive men with anal lesions experienced lesion clearance after using fluorouracil.
Previous studies indicate that both treatments have been well-tolerated, with most patients not experiencing severe side effects. However, some individuals might experience mild skin irritation where the cream is applied. This evidence suggests that these treatments are relatively safe options for those with anal lesions and HIV.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for anal lesions in HIV/AIDS patients because they offer unique approaches compared to traditional options. Imiquimod stands out by leveraging the immune system to fight off lesions, as it is an immune response modifier applied directly to the affected area. On the other hand, Fluorouracil acts as a topical chemotherapy agent, disrupting the DNA of abnormal cells to prevent their growth. Unlike more invasive procedures like surgery, these topical treatments could provide less painful and more convenient alternatives for patients, with potential for fewer side effects.
What evidence suggests that this trial's treatments could be effective for high-grade anal squamous skin lesions in HIV-positive patients?
This trial will compare the effectiveness of Imiquimod and Fluorouracil for treating anal intraepithelial neoplasia (AIN) in people with HIV. Studies have shown that Imiquimod, which participants in this trial may receive, can be effective, with 45% of patients showing complete or partial improvement. Imiquimod boosts the immune system to fight abnormal cells. Meanwhile, Fluorouracil, another treatment option in this trial, has cleared lesions in many HIV-positive patients; specifically, more than half of the patients in one study had their lesions cleared. Both treatments show promise in reducing the risk of high-grade lesions developing into anal cancer.12346
Who Is on the Research Team?
Timothy Wilkin
Principal Investigator
AIDS Associated Malignancies Clinical Trials Consortium
Are You a Good Fit for This Trial?
This trial is for HIV-positive patients with high-grade anal squamous skin lesions. They must have a Karnofsky performance status of >= 70%, CD4 count >= 200 or low viral load, and visible HSIL occupying at least 25% of the anal canal circumference. Exclusions include history of anal cancer, recent use of certain treatments like fluorouracil or imiquimod, ongoing anticoagulant therapy other than aspirin/NSAIDs, acute infections, systemic corticosteroids or immunomodulatory therapy usage.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either imiquimod or fluorouracil treatment, or observation. Imiquimod is applied intra-anally once daily for 16 weeks, while fluorouracil is applied intra-anally twice daily on days 1-5, repeating every 2 weeks for 8 courses.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits at weeks 20, 24, 26, 32, 40, and 44.
What Are the Treatments Tested in This Trial?
Interventions
- Fluorouracil
- Imiquimod
Trial Overview
The effectiveness of biological therapy imiquimod versus chemotherapy drug fluorouracil is being tested against observation alone in treating high-grade anal squamous skin lesions in HIV-positive patients. The study aims to determine which method stops tumor growth more effectively.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Patients apply fluorouracil intra-anally BID on days 1-5. Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients apply imiquimod intra-anally QD for 16 weeks.
Patients receive no treatment. Patients who still have HSIL at week 20 and who agree to randomization may cross-over to Arm A or B.
Fluorouracil is already approved in United States, European Union, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Skin cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AIDS Malignancy Consortium
Lead Sponsor
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
University of Arkansas
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
Topical 5-fluorouracil treatment of anal intraepithelial ...
A substantial proportion of HIV-positive MSM with AIN completely cleared their lesions with topical 5-FU treatment.
Treatment of Anal High-Grade Squamous Intraepithelial ...
The purpose of the Anal Cancer–HSIL Outcomes Research (ANCHOR) trial was to determine whether treating anal HSIL is effective and safe in ...
Imiquimod, Fluorouracil, or Observation in Treating HIV- ...
This randomized phase III trial studies imiquimod or fluorouracil to see how well they work compared to observation in treating patients with high-grade ...
Initial Experience with Topical Fluorouracil for Treatment of ...
We retrospectively reviewed records of the first 11 HIV-positive patients treated with topical 5-FU in our anal dysplasia clinic. Six (55%) ...
Topical 5‐fluorouracil treatment of anal intraepithelial ...
Topical 5‐fluorouracil treatment of anal intraepithelial neoplasia in human immunodeficiency virus‐positive men. O. Richel,. O. Richel. Department of Internal ...
Imiquimod and 5% Fluorouracil Therapy for Anal ...
A 59-year-old human immunodeficiency virus-1–positive (HIV-1+)white man presented with a nonhealing area that extended extensively aroundthe perianal skin.
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