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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT00550589
First received: October 26, 2007
Last updated: November 17, 2015
Last verified: November 2015
History of Changes
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
  Description
Cidofovir 1.0% topical cidofovir cream

Participant Flow:   Overall Study
    Cidofovir  
STARTED     33  
COMPLETED     33  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Cidofovir 1.0% topical cidofovir cream

Baseline Measures
    Cidofovir  
Number of Participants  
[units: participants]
 		  33  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     31  
>=65 years     2  
Age  
[units: years]
Mean (Standard Deviation) 		  44  (8.9)  
Gender  
[units: participants]
 		 
Female     9  
Male     24  
Region of Enrollment  
[units: participants]
 		 
United States     33  



  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 ]
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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 ]
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3.  Secondary:   Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue   [ Time Frame: Baseline ]
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4.  Secondary:   Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA   [ Time Frame: 6 weeks after treatment discontinuation ]
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5.  Secondary:   Identification of HPV-DNA Types Present in the Anus   [ Time Frame: Baseline ]
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6.  Secondary:   Identification of Abnormally Methylated Genes in Perianal Dysplasia   [ Time Frame: Baseline, after cycle 1, and 6 weeks after treatment discontinuation ]
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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 ]
  Show Outcome Measure 7

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 ]
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  Serious Adverse Events
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  Other Adverse Events
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  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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeannette Lee
Organization: Statistical Center of AIDS Malignancy Consortium
phone: (501) 526-6712
e-mail: jylee@uams.edu


Publications of Results:


Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00550589     History of Changes
Other Study ID Numbers: AMC-046
U01CA121947 ( US NIH Grant/Contract Award Number )
CDR0000570720 ( Other Identifier: NCI )
Study First Received: October 26, 2007
Results First Received: May 24, 2011
Last Updated: November 17, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board