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NCT02059499 · ClinicalTrials.gov registry record · Phase 3
Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions
A Phase 3 study, sponsored by AIDS Malignancy Consortium.
- Completed
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
NCT02059499: Completed Phase 3 study, sponsored by AIDS Malignancy Consortium.
NCT02059499 is a Phase 3 study that has completed, run by AIDS Malignancy Consortium. The registered enrollment target is 91 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02059499, a Phase 3 study, has completed, sponsored by AIDS Malignancy Consortium.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
Study 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.
Primary Outcome
Complete response is defined as the absence of HSIL histology for all biopsies and the absence of HSIL cytology. The percentage of participants achieving complete response in the 5-FU and observation arms will be reported and compared across sites, along with the corresponding p-value, using stratified Mantel-Haenszel-Cochran tests at a one-sided alpha level of 0.025.
Interventions
- OTHER laboratory biomarker analysis
- OTHER questionnaire administration
- DRUG fluorouracil
- DRUG imiquimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2015-12-28 |
| Est. Completion | 2024-05-02 |
| Phase | Phase 3 |
What the finished NCT02059499 record still lists
NCT02059499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT02059499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02059499 about?
NCT02059499 is a clinical study titled "Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions". 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 s...
What is the current status of trial NCT02059499?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2015-12-28. Estimated completion is 2024-05-02.
What interventions are being tested in trial NCT02059499?
The interventions under investigation include: laboratory biomarker analysis (OTHER), questionnaire administration (OTHER), fluorouracil (DRUG), imiquimod (DRUG).
Who is sponsoring clinical trial NCT02059499?
This trial is sponsored by AIDS Malignancy Consortium, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02059499's enrollment target sits among peer trials
91 1724th of 2000 higher than 277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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