Document Detail

Posaconazole for the treatment of azole-refractory oropharyngeal and esophageal candidiasis in subjects with HIV infection.
MedLine Citation:
PMID:  17243069     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: We evaluated the efficacy and safety of oral posaconazole for human immunodeficiency virus (HIV)-infected subjects with oropharyngeal candidiasis (OPC) and/or esophageal candidiasis (EC) who were clinically refractory to treatment with oral fluconazole or itraconazole.
METHODS: Subjects with confirmed OPC or EC who did not improve after receiving standard courses of fluconazole or itraconazole treatment were eligible for study enrollment. Subjects received either oral posaconazole (400 mg twice daily) for 3 days followed by oral posaconazole (400 mg once daily) for 25 days (regimen A; 103 patients) or oral posaconazole (400 mg twice daily) for 28 days (regimen B; 96 patients). The primary end point was cure or improvement after 28 days. Primary efficacy analyses were performed on the subset of treated subjects with refractory disease (e.g., baseline culture positive for fluconazole- or itraconazole-resistant Candida species or persistent or progressive clinical signs or symptoms consistent with treatment failure).
RESULTS: Of the modified intent-to-treat population, 132 (75%) of 176 subjects achieved a clinical response to posaconazole treatment. Clinical response rates were similar between regimen A recipients (75.3%) and regimen B recipients (74.7%). Clinical responses occurred in 67 (73%) of 92 subjects with baseline isolates resistant to fluconazole, 49 (74%) of 66 subjects with baseline isolates resistant to itraconazole, and 42 (74%) of 57 subjects with isolates resistant to both. Clinical response was achieved in 32 (74.4%) of 43 subjects with endoscopically documented EC. The most common treatment-related adverse events were diarrhea (11%), neutropenia (7%), flatulence (6%), and nausea (6%). Eight subjects (4%) discontinued therapy as a result of a treatment-related adverse event.
CONCLUSIONS: Posaconazole offers a safe and effective treatment option for HIV-infected subjects with azole-refractory OPC and/or EC.
Daniel J Skiest; Jose A Vazquez; Gregory M Anstead; John R Graybill; Jacques Reynes; Douglas Ward; Roberta Hare; Navdeep Boparai; Randi Isaacs
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2007-01-17
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  44     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2007 Feb 
Date Detail:
Created Date:  2007-01-23     Completed Date:  2007-02-28     Revised Date:  2013-11-25    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  607-14     Citation Subset:  IM    
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MeSH Terms
AIDS-Related Opportunistic Infections / diagnosis,  drug therapy*
Administration, Oral
Candidiasis / diagnosis,  drug therapy*
Candidiasis, Oral / diagnosis,  drug therapy
Confidence Intervals
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Resistance, Fungal
Esophageal Diseases / diagnosis,  drug therapy
Fluconazole / administration & dosage,  adverse effects
Follow-Up Studies
Itraconazole / administration & dosage,  adverse effects
Middle Aged
Severity of Illness Index
Treatment Failure
Treatment Outcome
Triazoles / administration & dosage*,  adverse effects
Reg. No./Substance:
0/Triazoles; 304NUG5GF4/Itraconazole; 6TK1G07BHZ/posaconazole; 8VZV102JFY/Fluconazole

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