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

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ClinicalTrials.gov Identifier: NCT00550589
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : June 22, 2011
Last Update Posted : December 21, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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

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

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 
Overall Participants Analyzed 
[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

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

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 ]
  Show Outcome Measure 2

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

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

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

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

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 ]
  Show Outcome Measure 8


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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 ( U.S. NIH Grant/Contract )
CDR0000570720 ( Other Identifier: NCI )
First Submitted: October 26, 2007
First Posted: October 30, 2007
Results First Submitted: May 24, 2011
Results First Posted: June 22, 2011
Last Update Posted: December 21, 2015