Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
NCT02135419 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,446 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AIDS Malignancy Consortium, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02135419 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, New York, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02135419?
This trial is sponsored by AIDS Malignancy Consortium, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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