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
Study identification
- NCT ID
- NCT02059499
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- AIDS Malignancy Consortium
- Network
- Enrollment
- 91 participants
Conditions and interventions
Interventions
- fluorouracil Drug
- imiquimod Drug
- laboratory biomarker analysis Other
- questionnaire administration 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 27, 2015
- Primary completion
- Dec 4, 2023
- Completion
- May 1, 2024
- Last update posted
- Jul 22, 2025
2015 – 2024
United States locations
- U.S. sites
- 0
- U.S. states
- 0
- U.S. cities
- 0
No U.S. locations are listed on this record.
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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 22, 2025 · Synced May 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02059499 live on ClinicalTrials.gov.