MedTrace Logo

Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus

NCT00550589 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2015-12-21

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

cidofovir

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.

GENETIC

DNA methylation analysis

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

GENETIC

gene expression analysis

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

GENETIC

polymerase chain reaction

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

PROCEDURE

biopsy

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

PROCEDURE

histopathologic examination

Evaluated at baseline and 6 weeks after treatment discontinuation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Elizabeth Stier, MD · Boston Medical Center

  • Joel Palefsky, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00550589 on ClinicalTrials.gov