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:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00550589
First received: October 26, 2007
Last updated: August 27, 2014
Last verified: August 2014
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

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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Human Papilloma Virus (HPV) DNA Type and HPV Strain Variant in Perianal HSIL and Normal Perianal Tissue   [ Time Frame: Baseline and 6 weeks after treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA   [ Time Frame: 6 weeks after treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Identification of HPV-DNA Types Present in the Anus and Cervix in Order to Compare Them With HPV-DNA Present in the Perianus   [ Time Frame: Baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Identification of Abnormally Methylated Genes in Perianal Dysplasia   [ Time Frame: Baseline, after cycle 1, and 6 weeks after treatment discontinuation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Cidofovir 1.0% topical cidofovir cream

Other Adverse Events
    Cidofovir  
Total, other (not including serious) adverse events    
# participants affected / at risk     32/33  
Blood and lymphatic system disorders    
Hemoglobin    
# participants affected / at risk     3/33 (9.09%)  
# events     3  
Hemorrhage, Anus    
# participants affected / at risk     5/33 (15.15%)  
# events     7  
Hemorrhage, other    
# participants affected / at risk     4/33 (12.12%)  
# events     5  
Neutropenia    
# participants affected / at risk     3/33 (9.09%)  
# events     6  
Anemia    
# participants affected / at risk     3/33 (9.09%)  
# events     3  
Gastrointestinal disorders    
Constipation    
# participants affected / at risk     3/33 (9.09%)  
# events     3  
Constitutional Symptoms    
# participants affected / at risk     4/33 (12.12%)  
# events     4  
Diarrhea    
# participants affected / at risk     6/33 (18.18%)  
# events     8  
Hemorrhage, Rectum    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Nausea    
# participants affected / at risk     4/33 (12.12%)  
# events     11  
Pain, anus    
# participants affected / at risk     9/33 (27.27%)  
# events     15  
Vomiting    
# participants affected / at risk     5/33 (15.15%)  
# events     5  
Vomiting    
# participants affected / at risk     5/33 (15.15%)  
# events     5  
General disorders    
Fatigue    
# participants affected / at risk     3/33 (9.09%)  
# events     4  
Pain, other    
# participants affected / at risk     2/33 (6.06%)  
# events     3  
Headache    
# participants affected / at risk     6/33 (18.18%)  
# events     7  
Pain, perineum    
# participants affected / at risk     14/33 (42.42%)  
# events     49  
Infections and infestations    
Infection, other    
# participants affected / at risk     3/33 (9.09%)  
# events     3  
Infection, lung    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Infection, upper airway    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Infection, vagina    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Infection, skin    
# participants affected / at risk     6/33 (18.18%)  
# events     9  
Upper respiratory infection    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Vaginal infection    
# participants affected / at risk     3/33 (9.09%)  
# events     4  
Metabolism and nutrition disorders    
AST,SGOT Elevation    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Metabolic, other    
# participants affected / at risk     6/33 (18.18%)  
# events     7  
Musculoskeletal and connective tissue disorders    
Pain, back    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Pain, Back    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Renal and urinary disorders    
Hemoglobinuria    
# participants affected / at risk     2/33 (6.06%)  
# events     4  
Proteinuria    
# participants affected / at risk     7/33 (21.21%)  
# events     7  
Respiratory, thoracic and mediastinal disorders    
Cough    
# participants affected / at risk     4/33 (12.12%)  
# events     4  
Pulmonary, other    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Respiratory, thoracic, other    
# participants affected / at risk     2/33 (6.06%)  
# events     2  
Skin and subcutaneous tissue disorders    
Dermatology/skin    
# participants affected / at risk     13/33 (39.39%)  
# events     21  
Pruritus    
# participants affected / at risk     11/33 (33.33%)  
# events     21  
Decubitus ulcer    
# participants affected / at risk     2/33 (6.06%)  
# events     3  
Ulceration    
# participants affected / at risk     12/33 (36.36%)  
# events     25  
Skin ulceration    
# participants affected / at risk     17/33 (51.52%)  
# events     30  



  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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