A multicenter randomized trial evaluating posaconazole versus fluconazole for the treatment of oropharyngeal candidiasis in subjects with HIV/AIDS

Jose Antonio Vazquez, Daniel J. Skiest, Leopoldo Nieto, Rebeca Northland, Ian Sanne, Jagadish Gogate, Wayne Greaves, Randi Isaacs

Research output: Contribution to journalArticle

143 Citations (Scopus)

Abstract

Background. Oropharyngeal candidiasis is the most common opportunistic infection among persons infected with human immunodeficiency virus (HIV). Use of some agents is hampered by lack of efficacy, emergence of resistance, adverse events, and need for intravenous administration. Posaconazole is an extended-spectrum triazole with potent in vitro activity against Candida species, including Candida albicans, Candida glabrata, and Candida krusei (including fluconazole-resistant strains). Methods. This multicenter, randomized, evaluator-blinded study of subjects with HIV infection and oropharyngeal candidiasis compared efficacy of posaconazole with that of fluconazole. Subjects received either 200 mg of posaconazole or fluconazole oral suspension on day 1, followed by 100 mg/day for 13 days. The primary study end point-clinical success (cure or improvement) on day 14-was evaluated for 329 subjects. Durability of clinical success was evaluated on day 42. Results. Three hundred fifty subjects received posaconazole (n = 178) or fluconazole (n = 172). Clinical success occurred in 155 (91.7%) of 169 posaconazole recipients and in 148 (92.5%) of 160 fluconazole recipients (95% confidence interval, -6.61% to 5.04%), indicating that posaconazole was not inferior to fluconazole. On day 14, mycological success was 68% in both arms, but by day 42, significantly more posaconazole recipients than fluconazole recipients continued to have mycological success (40.6% vs. 26.4%; P = .038). Fewer posaconazole recipients than fluconazole recipients experienced clinical relapse (31.5% vs. 38.2%). Adverse events were similar between treatment arms. Conclusions. Results demonstrate that posaconazole was as effective as fluconazole in producing a successful clinical outcome. However, posaconazole was more effective in sustaining clinical success after treatment was stopped.

Original languageEnglish (US)
Pages (from-to)1179-1186
Number of pages8
JournalClinical Infectious Diseases
Volume42
Issue number8
DOIs
StatePublished - Apr 15 2006

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Fluconazole
Candidiasis
Multicenter Studies
Acquired Immunodeficiency Syndrome
HIV
Therapeutics
Candida
posaconazole
Candida glabrata
Triazoles
Opportunistic Infections
Virus Diseases
Candida albicans
Intravenous Administration
Suspensions
Confidence Intervals
Recurrence

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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A multicenter randomized trial evaluating posaconazole versus fluconazole for the treatment of oropharyngeal candidiasis in subjects with HIV/AIDS. / Vazquez, Jose Antonio; Skiest, Daniel J.; Nieto, Leopoldo; Northland, Rebeca; Sanne, Ian; Gogate, Jagadish; Greaves, Wayne; Isaacs, Randi.

In: Clinical Infectious Diseases, Vol. 42, No. 8, 15.04.2006, p. 1179-1186.

Research output: Contribution to journalArticle

Vazquez, Jose Antonio ; Skiest, Daniel J. ; Nieto, Leopoldo ; Northland, Rebeca ; Sanne, Ian ; Gogate, Jagadish ; Greaves, Wayne ; Isaacs, Randi. / A multicenter randomized trial evaluating posaconazole versus fluconazole for the treatment of oropharyngeal candidiasis in subjects with HIV/AIDS. In: Clinical Infectious Diseases. 2006 ; Vol. 42, No. 8. pp. 1179-1186.
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abstract = "Background. Oropharyngeal candidiasis is the most common opportunistic infection among persons infected with human immunodeficiency virus (HIV). Use of some agents is hampered by lack of efficacy, emergence of resistance, adverse events, and need for intravenous administration. Posaconazole is an extended-spectrum triazole with potent in vitro activity against Candida species, including Candida albicans, Candida glabrata, and Candida krusei (including fluconazole-resistant strains). Methods. This multicenter, randomized, evaluator-blinded study of subjects with HIV infection and oropharyngeal candidiasis compared efficacy of posaconazole with that of fluconazole. Subjects received either 200 mg of posaconazole or fluconazole oral suspension on day 1, followed by 100 mg/day for 13 days. The primary study end point-clinical success (cure or improvement) on day 14-was evaluated for 329 subjects. Durability of clinical success was evaluated on day 42. Results. Three hundred fifty subjects received posaconazole (n = 178) or fluconazole (n = 172). Clinical success occurred in 155 (91.7{\%}) of 169 posaconazole recipients and in 148 (92.5{\%}) of 160 fluconazole recipients (95{\%} confidence interval, -6.61{\%} to 5.04{\%}), indicating that posaconazole was not inferior to fluconazole. On day 14, mycological success was 68{\%} in both arms, but by day 42, significantly more posaconazole recipients than fluconazole recipients continued to have mycological success (40.6{\%} vs. 26.4{\%}; P = .038). Fewer posaconazole recipients than fluconazole recipients experienced clinical relapse (31.5{\%} vs. 38.2{\%}). Adverse events were similar between treatment arms. Conclusions. Results demonstrate that posaconazole was as effective as fluconazole in producing a successful clinical outcome. However, posaconazole was more effective in sustaining clinical success after treatment was stopped.",
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T1 - A multicenter randomized trial evaluating posaconazole versus fluconazole for the treatment of oropharyngeal candidiasis in subjects with HIV/AIDS

AU - Vazquez, Jose Antonio

AU - Skiest, Daniel J.

AU - Nieto, Leopoldo

AU - Northland, Rebeca

AU - Sanne, Ian

AU - Gogate, Jagadish

AU - Greaves, Wayne

AU - Isaacs, Randi

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N2 - Background. Oropharyngeal candidiasis is the most common opportunistic infection among persons infected with human immunodeficiency virus (HIV). Use of some agents is hampered by lack of efficacy, emergence of resistance, adverse events, and need for intravenous administration. Posaconazole is an extended-spectrum triazole with potent in vitro activity against Candida species, including Candida albicans, Candida glabrata, and Candida krusei (including fluconazole-resistant strains). Methods. This multicenter, randomized, evaluator-blinded study of subjects with HIV infection and oropharyngeal candidiasis compared efficacy of posaconazole with that of fluconazole. Subjects received either 200 mg of posaconazole or fluconazole oral suspension on day 1, followed by 100 mg/day for 13 days. The primary study end point-clinical success (cure or improvement) on day 14-was evaluated for 329 subjects. Durability of clinical success was evaluated on day 42. Results. Three hundred fifty subjects received posaconazole (n = 178) or fluconazole (n = 172). Clinical success occurred in 155 (91.7%) of 169 posaconazole recipients and in 148 (92.5%) of 160 fluconazole recipients (95% confidence interval, -6.61% to 5.04%), indicating that posaconazole was not inferior to fluconazole. On day 14, mycological success was 68% in both arms, but by day 42, significantly more posaconazole recipients than fluconazole recipients continued to have mycological success (40.6% vs. 26.4%; P = .038). Fewer posaconazole recipients than fluconazole recipients experienced clinical relapse (31.5% vs. 38.2%). Adverse events were similar between treatment arms. Conclusions. Results demonstrate that posaconazole was as effective as fluconazole in producing a successful clinical outcome. However, posaconazole was more effective in sustaining clinical success after treatment was stopped.

AB - Background. Oropharyngeal candidiasis is the most common opportunistic infection among persons infected with human immunodeficiency virus (HIV). Use of some agents is hampered by lack of efficacy, emergence of resistance, adverse events, and need for intravenous administration. Posaconazole is an extended-spectrum triazole with potent in vitro activity against Candida species, including Candida albicans, Candida glabrata, and Candida krusei (including fluconazole-resistant strains). Methods. This multicenter, randomized, evaluator-blinded study of subjects with HIV infection and oropharyngeal candidiasis compared efficacy of posaconazole with that of fluconazole. Subjects received either 200 mg of posaconazole or fluconazole oral suspension on day 1, followed by 100 mg/day for 13 days. The primary study end point-clinical success (cure or improvement) on day 14-was evaluated for 329 subjects. Durability of clinical success was evaluated on day 42. Results. Three hundred fifty subjects received posaconazole (n = 178) or fluconazole (n = 172). Clinical success occurred in 155 (91.7%) of 169 posaconazole recipients and in 148 (92.5%) of 160 fluconazole recipients (95% confidence interval, -6.61% to 5.04%), indicating that posaconazole was not inferior to fluconazole. On day 14, mycological success was 68% in both arms, but by day 42, significantly more posaconazole recipients than fluconazole recipients continued to have mycological success (40.6% vs. 26.4%; P = .038). Fewer posaconazole recipients than fluconazole recipients experienced clinical relapse (31.5% vs. 38.2%). Adverse events were similar between treatment arms. Conclusions. Results demonstrate that posaconazole was as effective as fluconazole in producing a successful clinical outcome. However, posaconazole was more effective in sustaining clinical success after treatment was stopped.

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