TY - JOUR
T1 - A controlled trial of itraconazole as primary prophylaxis for systemic fungal infections in patients with advanced human immunodeficiency virus infection in Thailand
AU - Chariyalertsak, Suwat
AU - Supparatpinyo, Khuanchai
AU - Sirisanthana, Thira
AU - Nelson, Kenrad E.
N1 - Funding Information:
Financial support: Grant from Janssen Research Foundation (Bangkok, Thailand).
PY - 2002/1/15
Y1 - 2002/1/15
N2 - Cryptococcal meningitis and Penicillium marneffei infection are common serious fungal infections in patients infected with human immunodeficiency virus (HIV) in Southeast Asia. In a prospective, double-blind trial, 63 patients with HIV infection and CD4+ lymphocyte counts of <200 cells/μL were randomized to receive oral itraconazole (200 mg per day), and 66 similar patients received a matched placebo. Both groups were monitored for evidence of invasive fungal infections. Baseline characteristics and the CD4+ cell counts of the 2 groups were similar. In the intent-to-treat analysis, a systemic fungal infection developed in 1 patient (1.6%) assigned to receive itraconazole (P. marneffei) and in 11 patients (16.7%) given placebo (7 patients had cryptococcal meningitis, and 4 patients had P. marneffei infection; P = .003, by the log-rank test). The incidence of recurrent or refractory mucosal candidiasis was significantly reduced in the itraconazole group. The 2 groups did not differ with regard to adverse effects. Primary prophylaxis with oral itraconazole is well tolerated and prevents cryptococcosis and penicilliosis marneffei in patients with advanced HIV infection, especially those with CD4+ lymphocyte counts of ≤100 cells/μL. However, prophylaxis with itraconazole was not found to be associated with a survival advantage when it was given to patients with advanced HIV disease.
AB - Cryptococcal meningitis and Penicillium marneffei infection are common serious fungal infections in patients infected with human immunodeficiency virus (HIV) in Southeast Asia. In a prospective, double-blind trial, 63 patients with HIV infection and CD4+ lymphocyte counts of <200 cells/μL were randomized to receive oral itraconazole (200 mg per day), and 66 similar patients received a matched placebo. Both groups were monitored for evidence of invasive fungal infections. Baseline characteristics and the CD4+ cell counts of the 2 groups were similar. In the intent-to-treat analysis, a systemic fungal infection developed in 1 patient (1.6%) assigned to receive itraconazole (P. marneffei) and in 11 patients (16.7%) given placebo (7 patients had cryptococcal meningitis, and 4 patients had P. marneffei infection; P = .003, by the log-rank test). The incidence of recurrent or refractory mucosal candidiasis was significantly reduced in the itraconazole group. The 2 groups did not differ with regard to adverse effects. Primary prophylaxis with oral itraconazole is well tolerated and prevents cryptococcosis and penicilliosis marneffei in patients with advanced HIV infection, especially those with CD4+ lymphocyte counts of ≤100 cells/μL. However, prophylaxis with itraconazole was not found to be associated with a survival advantage when it was given to patients with advanced HIV disease.
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U2 - 10.1086/338154
DO - 10.1086/338154
M3 - Article
C2 - 11740718
AN - SCOPUS:0037079884
SN - 1058-4838
VL - 34
SP - 277
EP - 284
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 2
ER -