title: Itraconazole prophylaxis for fungal infections in patients with advanced human immunodeficiency virus infection: randomized, placebo-controlled, double-blind study. National Institute of Allergy and Infectious Diseases Mycoses Study Group.
abstract: In a prospective, randomized, double-blind trial, 149 patients with advanced human immunodeficiency virus (HIV) infection were randomized to receive itraconazole capsules (200 mg daily) and 146 to receive a matched placebo. Both groups were monitored for evidence of fungal infections. Baseline characteristics of the two groups were similar. Failure of prophylaxis occurred in 29 (19%) of the itraconazole recipients and 42 (29%) of the placebo recipients (P = .004; log-rank test). There were 6 invasive fungal infections in the itraconazole group (4, histoplasmosis; 1, cryptococcosis; 1, aspergillosis) and 19 in the placebo group (10, histoplasmosis; 8, cryptococcosis; 1, aspergillosis) (P = .0007; log-rank test). Itraconazole significantly delayed time to onset of histoplasmosis (P = .03; log-rank test) and cryptococcosis (P = .0005; log-rank test). Prophylaxis failure due to recurrent or refractory mucosal candidiasis occurred with similar frequency in the two groups (itraconazole, 15%; placebo, 16%). A survival benefit was not demonstrated. Itraconazole generally was well tolerated. Primary prophylaxis with itraconazole capsules prevents histoplasmosis and cryptococcosis in patients with HIV infection.
authors.affiliation: University of Missouri-Kansas City School of Medicine, and Kansas City AIDS Research Consortium, USA. dmckinsey@prodigy.net
authors.forename: D S
authors.initials: DS
authors.lastname: McKinsey
authors.forename: L J
authors.initials: LJ
authors.lastname: Wheat
authors.forename: G A
authors.initials: GA
authors.lastname: Cloud
authors.forename: M
authors.initials: M
authors.lastname: Pierce
authors.forename: J R
authors.initials: JR
authors.lastname: Black
authors.forename: D M
authors.initials: DM
authors.lastname: Bamberger
authors.forename: M
authors.initials: M
authors.lastname: Goldman
authors.forename: C J
authors.initials: CJ
authors.lastname: Thomas
authors.forename: H M
authors.initials: HM
authors.lastname: Gutsch
authors.forename: B
authors.initials: B
authors.lastname: Moskovitz
authors.forename: W E
authors.initials: WE
authors.lastname: Dismukes
authors.forename: C A
authors.initials: CA
authors.lastname: Kauffman
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000401:mortality / Q000517:prevention & control*; D000328:Adult; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000401:mortality; D006801:Humans; D017964:Itraconazole / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009181:Mycoses / Q000401:mortality / Q000517:prevention & control*; D011446:Prospective Studies; D016019:Survival Analysis; D017211:Treatment Failure
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole