Document Detail


Safety and efficacy of topical cidofovir to treat high-grade perianal and vulvar intraepithelial neoplasia in HIV-positive men and women.
MedLine Citation:
PMID:  23032420     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the safety and efficacy of topical cidofovir for treatment of high-grade squamous perianal intraepithelial neoplasia (PAIN) and vulvar intraepithelial neoplasia (VIN) lesions in HIV-positive individuals.
DESIGN: Phase IIa prospective multicenter trial conducted at eight clinical sites through the AIDS Malignancy Consortium.
METHODS: : HIV-positive patients with biopsy-proven high-grade PAIN that was at least 3 cm were enrolled. PAIN biopsy specimens were assessed for human papillomavirus (HPV) using PCR and type-specific HPV probing. Participants applied 1% topical cidofovir to PAIN and VIN (if present) for six 2-week cycles. Results were designated as complete response (CR), partial response (PR) (>50% reduction in size), stable disease, or progressive disease (PD).
RESULTS: Twenty-four men and nine women (eight with high-grade VIN as well) were enrolled. Mean age was 44 years and mean CD4 cell count was 412 cells/μl. HPV DNA (most commonly HPV16) was detected in all pretreatment study specimens. Twenty six (79%) participants completed treatment per protocol: CR, five (15%); PR, 12 (36%), stable disease, seven (21%); PD, two (6%) (one with a superficially invasive cancer and one with new area of high-grade PAIN). Treatment was well tolerated with most common adverse events being mild to moderate affecting lesional skin: pain/burning/irritation (25 patients) and ulceration (13 patients).
CONCLUSION: Topical cidofovir had 51% efficacy in the short-term treatment of high-grade PAIN and VIN with acceptable toxicity in HIV-positive individuals. Randomized control studies with more prolonged treatment courses and longer follow-up to assess the durability of the response are needed.
Authors:
Elizabeth A Stier; Stephen E Goldstone; Mark H Einstein; Naomi Jay; John M Berry; Timothy Wilkin; Jeannette Y Lee; Teresa M Darragh; Maria Da Costa; Lori Panther; David Aboulafia; Joel M Palefsky
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  AIDS (London, England)     Volume:  27     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-31     Completed Date:  2013-08-21     Revised Date:  2014-03-28    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  545-51     Citation Subset:  IM; X    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00550589
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MeSH Terms
Descriptor/Qualifier:
Acquired Immunodeficiency Syndrome / complications,  drug therapy*,  pathology
Administration, Cutaneous
Adult
Aged
Antiviral Agents / administration & dosage*,  pharmacology
Anus Neoplasms / drug therapy*,  pathology
CD4 Lymphocyte Count
Carcinoma in Situ / drug therapy*,  pathology
Cytosine / administration & dosage,  analogs & derivatives*,  pharmacology
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Humans
Male
Middle Aged
Neoplasm Proteins / drug effects,  metabolism
Organophosphonates / administration & dosage*,  pharmacology
Perineum / pathology*
Prospective Studies
Vulvar Neoplasms / drug therapy*,  pathology
Grant Support
ID/Acronym/Agency:
P30 CA013330/CA/NCI NIH HHS; R21 CA117081/CA/NCI NIH HHS; R21 CA117081/CA/NCI NIH HHS; U01 CA121947/CA/NCI NIH HHS; UL1 TR000457/TR/NCATS NIH HHS; UO1 CA 121947/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/Neoplasm Proteins; 0/Organophosphonates; 0/P16 protein, human; 8J337D1HZY/Cytosine; JIL713Q00N/cidofovir
Comments/Corrections

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