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

This study has been completed.
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium Identifier:
First received: October 26, 2007
Last updated: September 22, 2015
Last verified: September 2015
Results First Received: May 24, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anal Cancer
Precancerous Condition
Interventions: Drug: cidofovir
Genetic: DNA methylation analysis
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Procedure: biopsy
Procedure: histopathologic examination

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Cidofovir 1.0% topical cidofovir cream

Participant Flow:   Overall Study
STARTED     33  
COMPLETED     33  

  Baseline Characteristics

  Outcome Measures
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1.  Primary:   Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL)   [ Time Frame: 6 weeks after treatment discontinuation ]

2.  Primary:   Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0   [ Time Frame: Every 2 weeks on study, 6 weeks after treatment discontinuation ]

3.  Secondary:   Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue   [ Time Frame: Baseline ]

4.  Secondary:   Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA   [ Time Frame: 6 weeks after treatment discontinuation ]

5.  Secondary:   Identification of HPV-DNA Types Present in the Anus   [ Time Frame: Baseline ]

6.  Secondary:   Identification of Abnormally Methylated Genes in Perianal Dysplasia   [ Time Frame: Baseline, after cycle 1, and 6 weeks after treatment discontinuation ]

7.  Secondary:   Distribution of Abnormally Methylated Genes Among HSIL, Low-grade Squamous Intraepithelial Lesions, and Normal Perianal Skin   [ Time Frame: Baseline, after cycle 1, and 6 weeks after treatment discontinuation ]

8.  Secondary:   Changes in Gene Expression in Perianal HSIL After Exposure to Cidofovir as Assessed by RNA Microarray Analysis   [ Time Frame: Baseline, after cycle 1, and 6 weeks after treatment discontinuation ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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