Imiquimod vs. Fluorouracil for Anal Lesions in HIV/AIDS

Recruiting at 12 trial locations

Overseen By Lisa Flowers, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AIDS Malignancy Consortium

Must not be taking: Anticoagulants, Corticosteroids, Cytokines, others

Disqualifiers: Anal cancer, Extensive HSIL, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

91 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase III trial studies imiquimod or fluorouracil to see how well they work compared to observation in treating patients with high-grade anal squamous skin lesions who are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether imiquimod or fluorouracil is more effective than observation in treating high-grade anal squamous skin lesions.

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

I am HIV-positive with documented test results or a doctor's diagnosis.

Platelet count >= 75,000/mm^3 within 90 days prior to enrollment

My recent biopsy showed high-grade anal lesions.

Exclusion Criteria

My cancer needs treatment that affects my whole body.

I have been vaccinated against HPV.

I am not currently taking steroids, cytokines, or immunomodulatory therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

16 weeks

Regular visits as per treatment protocol

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.

24 weeks

6 visits (in-person)

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?

Group I: Arm B (fluorouracil) Experimental Treatment 3 Interventions

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.

Group II: Arm A (imiquimod) Experimental Treatment 3 Interventions

Patients apply imiquimod intra-anally QD for 16 weeks.

Group III: Arm C (observation) Active Control 1 Intervention

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:

Approved in United States as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer
• Skin cancer

Approved in European Union as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer

Approved in Canada as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

AIDS Malignancy Consortium

Lead Sponsor

Trials

64

Recruited

9,600+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

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

Trials

500

Recruited

153,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+