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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 is a Phase 3 study that has completed, run by AIDS Malignancy Consortium. The registered enrollment target is 91 participants.

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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.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER questionnaire administration
  • DRUG fluorouracil
  • DRUG imiquimod

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2015-12-28
Est. Completion 2024-05-02
Phase Phase 3

Sponsor

AIDS Malignancy Consortium

45 total trials

What the Registry Record Tells You About NCT02059499

The ClinicalTrials.gov registry entry for NCT02059499 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AIDS Malignancy Consortium, which has 45 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT02059499 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.