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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
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 
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
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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
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Time Frame No text entered.
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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 (96.97%) 
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 
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 
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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