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
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Sponsor:
AIDS Malignancy Consortium
Collaborators:
National Cancer Institute (NCI)
The Emmes Company, LLC
Information provided by (Responsible Party):
AIDS Malignancy Consortium
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Study Type | Interventional |
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Study Design | Allocation: N/A; 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 |
Enrollment | 33 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Cidofovir |
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1.0% topical cidofovir cream |
Period Title: Overall Study | |
Started | 33 |
Completed | 33 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Cidofovir | |
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1.0% topical cidofovir cream | |
Overall Number of Baseline Participants | 33 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 33 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
31 93.9%
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>=65 years |
2 6.1%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 33 participants | |
44 (8.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 33 participants | |
Female |
9 27.3%
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Male |
24 72.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 33 participants |
33 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Jeannette Lee |
Organization: | Statistical Center of AIDS Malignancy Consortium |
Phone: | (501) 526-6712 |
EMail: | jylee@uams.edu |
Responsible Party: | AIDS Malignancy Consortium |
ClinicalTrials.gov Identifier: | NCT00550589 |
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 |