Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions
Public ClinicalTrials.gov record NCT02059499. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02059499
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 91 participants
Conditions and interventions
Interventions
- imiquimod Drug
- fluorouracil Drug
- questionnaire administration Other
- laboratory biomarker analysis Other
Drug · Other
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2015 (Actual)
- Primary completion
- Dec 5, 2023 (Actual)
- Completion
- May 2, 2024 (Actual)
- Last update posted
- Jul 23, 2025
2015 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA CARE Center | Los Angeles | California | 90035 | — |
| UCSF-Mount Zion | San Francisco | California | 94115 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Louisiana State University Health Sciences Center - New Orleans | New Orleans | Louisiana | 70112 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Laser Surgery Care | New York | New York | 10011 | — |
| Cornell Clinical Trials Unit, New York Presbyterian Hospital | New York | New York | 10065 | — |
| Weill Medical College of Cornell University | New York | New York | 10065 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Benaroya Research Institute at Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02059499, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 23, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02059499 live on ClinicalTrials.gov.