CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
cidofovir +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00550589
NCT00550589Phase 2Completed
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Phase IIA Trial of 1% Topical Cidofovir for Treatment of High-Grade Perianal Squamous Intraepithelial Lesions in HIV-Infected Men and Women

AIDS Malignancy Consortium·interventional·Posted Oct 30, 2007·Updated Dec 21, 2015

In Brief

A Phase 2 clinical trial evaluating cidofovir, DNA methylation analysis, and 4 other interventions for Anal Cancer and Precancerous Condition. Completed, enrolled 33 participants across 8 sites.

Detailed Summary

RATIONALE: High-grade squamous intraepithelial lesions of the skin near the anus are caused by the human papillomavirus (HPV). Antiviral drugs,, such as cidofovir, act against viruses and may stop these lesions from becoming cancer. PURPOSE: This phase II trial is studying the side effects and how well topical cidofovir works in treating HIV-infected patients with high-grade squamous intraepithelial lesions of the skin near the anus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Cancer, Precancerous Condition
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), The Emmes Company, LLC

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 30, 2007
Enrollment StartSep 1, 2007
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.7 years ago

Interventions

cidofovirdrug

1.0% topical cream self-applied once daily for 5 consecutive days, with no treatment for the remaining 9 days (a treatment cycle). Subjects will receive up to 6 cycles of treatment.

DNA methylation analysisgenetic

formalin fixed biopsy collected at baseline and 6 weeks after treatment discontinuation

gene expression analysisgenetic

punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation

polymerase chain reactiongenetic

performed on punch biopsy specimens collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation

biopsyprocedure

punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation

histopathologic examinationprocedure

Evaluated at baseline and 6 weeks after treatment discontinuation