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Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions

NCT02059499 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-07-23

Study results available
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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.

Conditions

  • Anal Intraepithelial Neoplasia
  • High-grade Squamous Intraepithelial Lesion
  • HIV Infection

Interventions

DRUG

imiquimod

Given intra-anally

DRUG

fluorouracil

Given intra-anally

OTHER

questionnaire administration

Ancillary studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • University of Arkansas

    collaborator OTHER

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Timothy Wilkin · AIDS Associated Malignancies Clinical Trials Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-28
Primary Completion
2023-12-05
Completion
2024-05-02

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059499 on ClinicalTrials.gov