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Anti-metabolites

Imiquimod vs. Fluorouracil for Anal Lesions in HIV/AIDS

Phase 3

Waitlist Available

Led By Timothy Wilkin

Research Sponsored by AIDS Malignancy Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HSIL occupies at least 25% of the circumference of the anal canal at either the squamocolumnar junction or distal anus on high-resolution anoscopy (HRA) at screening or entry based on available biopsy results and visual appearance

Karnofsky performance status of >= 70%

Must not have

Prior history of HPV vaccination

Concurrent systemic corticosteroids, cytokines, and immunomodulatory therapy (e.g. interferons)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 48

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing imiquimod to fluorouracil to see how well they work in treating patients with high-grade anal squamous skin lesions who are HIV-positive.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Imiquimod may cause local skin reactions such as redness and irritation while fluorouracil can lead to symptoms including soreness at the application site, increased sensitivity to sunlight, and potentially mild systemic effects like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My anal canal has a significant area affected by high-grade lesions.

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I am able to care for myself but may not be able to do active work.

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I have visible anal pre-cancerous lesions with no signs of invasive cancer.

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My CD4 count is at least 200 or my HIV viral load is under 200 copies/mL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been vaccinated against HPV.

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

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I do not have severe HSIL or warts in the perianal/vulvar area that need immediate different treatment.

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I have had anal cancer in the past.

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I am currently taking blood thinners other than aspirin or NSAIDs.

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My anal warts cover more than half of the anal area or prevent a proper exam.

Select...

I haven't been treated for a serious infection or illness in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants achieving complete response (Arm A and B)

Proportion of participants with spontaneous regression (Arm C)

Secondary study objectives

Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Number of quadrants with HSIL found on biopsies

Persistence of HPV type specific infections

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (fluorouracil)Experimental Treatment3 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 Treatment3 Interventions

Patients apply imiquimod intra-anally QD for 16 weeks.

Group III: Arm C (observation)Active Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

fluorouracil

1994

Completed Phase 3

~8440