At a glance
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A Randomized, Phase III Study of Intra-anal Imiquimod 2.5% vs. Topical 5-fluorouracil 5% vs. Observation for the Treatment of High-grade Anal Squamous Intraepithelial Lesions in HIV-infected Men and Women
In Brief
A Phase 3 clinical trial evaluating imiquimod, fluorouracil, and 2 other interventions for Anal Intraepithelial Neoplasia and 2 related conditions. Completed, enrolled 91 participants across 13 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Given intra-anally
Given intra-anally
Ancillary studies
Correlative studies