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NCT02135419 · ClinicalTrials.gov registry record · Phase 3
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
A Phase 3 study of HIV Infection and Anal Cancer, sponsored by AIDS Malignancy Consortium.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,446
- Enrollment target
- 20
- Study locations
NCT02135419 is a Phase 3 study of HIV Infection and Anal Cancer that has completed, run by AIDS Malignancy Consortium. The registered enrollment target is 4,446 participants, above the 182-participant average among 73 other HIV Infection trials with a reported enrollment target (2343% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT02135419, a Phase 3 study of HIV Infection and Anal Cancer, has completed, sponsored by AIDS Malignancy Consortium.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,446 participants
- Enrollment target
- 20
- Study locations
Study Summary
The randomized phase of the trial compared topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer. The ANCHOR Data Safety Monitoring Board (DSMB) determined that the primary study endpoint was completed, based on the data and statistical analysis presented to them on 07SEP2021. In the post-randomization phase of this trial, all enrolled participants are offered treatment for HSIL and/or follow-up, at the participant's choice.
Conditions Studied
Interventions
- DRUG fluorouracil
- DRUG imiquimod
- DEVICE infrared photocoagulation therapy
- DEVICE thermal ablation therapy
- DEVICE laser therapy
Study Locations (20)
California
- UCLA CARE Clinic - Los Angeles
- UCLA School of Nursing - Los Angeles
- DAP Health - Palm Springs
- University of California at San Francisco Anal Dysplasia Clinic - San Francisco
New York
- Cornell Clinical Trials Unit, Chelsea Center - New York
- Laser Surgery Care - New York
- Montefiore - Albert Einstein College of Medicine - The Bronx
Colorado
- University of Colorado Hospital - Aurora
- Denver Public Health - Denver
District of Columbia
- Capital Digestive Care - Washington D.C.
- Dupont Circle Physicians Group - Washington D.C.
Florida
- ACC Clinic, Jackson Hospital - Miami
- University of Miami Miller School of Medicine - Sylvester Cancer Center - Miami
Louisiana
- University Medical Center New Orleans - New Orleans
- CrescentCare Health - New Orleans
Massachusetts
- Boston Medical Center - Boston
- Fenway Health - Boston
Georgia
- Grady Health System - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,446 participants |
| Start Date | 2014-09-24 |
| Est. Completion | 2024-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02135419
The ClinicalTrials.gov registry entry for NCT02135419 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,446 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 182-participant average among 73 other HIV Infection trials with a reported enrollment target (2343% higher). The listed sponsor is AIDS Malignancy Consortium, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with HIV Infection appearing as the primary indexed condition, and to 5 interventions - of which fluorouracil is the first listed.
NCT02135419 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, New York, Colorado.
Frequently Asked Questions
What is clinical trial NCT02135419 about?
NCT02135419 is a clinical study titled "Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions". The randomized phase of the trial compared topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infecti...
What is the current status of trial NCT02135419?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,446 participants. The study started on 2014-09-24. Estimated completion is 2024-03-31.
What conditions does trial NCT02135419 study?
This clinical trial studies the following conditions: HIV Infection, Anal Cancer, Human Papilloma Virus Infection, High-grade Squamous Intraepithelial Lesion.
What interventions are being tested in trial NCT02135419?
The interventions under investigation include: fluorouracil (DRUG), imiquimod (DRUG), infrared photocoagulation therapy (DEVICE), thermal ablation therapy (DEVICE), laser therapy (DEVICE).
Who is sponsoring clinical trial NCT02135419?
This trial is sponsored by AIDS Malignancy Consortium, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02135419 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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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.