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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 48
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants achieving complete response (Arm A and B)
Proportion of participants with spontaneous regression (Arm C)
Secondary outcome measures
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 moreTrial 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
imiquimod
2008
Completed Phase 3
~750
Find a Location
Who is running the clinical trial?
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,400 Total Patients Enrolled
University of ArkansasOTHER
486 Previous Clinical Trials
150,262 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,062 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV-positive with documented test results or a doctor's diagnosis.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.My recent biopsy showed high-grade anal lesions.I can understand and am willing to sign the informed consent.I am not pregnant or breastfeeding and agree to use birth control during and after treatment.My anal canal has a significant area affected by high-grade lesions.I am able to care for myself but may not be able to do active work.I do not have severe HSIL or warts in the perianal/vulvar area that need immediate different treatment.I have had a recent cervical screening and gynecologic exam.I have visible anal pre-cancerous lesions with no signs of invasive cancer.I have had anal cancer in the past.I have used specific topical treatments for anal conditions before.I am currently taking blood thinners other than aspirin or NSAIDs.My CD4 count is at least 200 or my HIV viral load is under 200 copies/mL.My anal warts cover more than half of the anal area or prevent a proper exam.I haven't had treatment for anal or perianal skin lesions in the last 4 months.I haven't been treated for a serious infection or illness in the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (imiquimod)
- Group 2: Arm B (fluorouracil)
- Group 3: Arm C (observation)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what purpose is fluorouracil typically employed?
"While usually used to treat superficial basal cell carcinoma, fluorouracil can also be effective against rectal carcinoma, communicable diseases, and scalp structure."
Answered by AI
Is fluorouracil a common drug used in research?
"There are a total of 111 phase 3 trials and 351 clinical trials in progress for fluorouracil. Most of these studies are based in Houston, Texas, however, there are 19117 total locations running these studies."
Answered by AI
What are researchers hoping to discover or prove with this clinical trial?
"The sponsor of the study, The Emmes Company, LLC, reports that the primary objective is to measure the Proportion of participants achieving complete response (Arm A and B) over a At week 20 time frame. Additionally, this study will evaluate secondary outcomes such as the Incidence of adverse events and the Number of quadrants with HSIL found on biopsies."
Answered by AI
Has the FDA cleared fluorouracil for public use?
"We have given fluorouracil a safety rating of 3 because this medication has undergone Phase 3 trials. This means that there is existing data to support its efficacy and multiple rounds of data to support its safety."
Answered by AI
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