Itraconazole compared with amphotericin B plus flucytosine in AIDS patients with cryptococcal meningitis.
OBJECTIVE
We conducted a comparison of itraconazole versus amphotericin B plus flucytosine in the initial treatment of cryptococcal meningitis in patients with AIDS and established the efficacy of itraconazole as maintenance treatment.


METHODS
The trial was a prospective, randomized, and non-blinded study.


METHODS
The study was performed at an academic centre for AIDS, Amsterdam, The Netherlands.


METHODS
Twenty-eight HIV-1-seropositive men with a presumptive diagnosis of cryptococcal meningitis, randomized between 5 February 1987 and 1 January 1990, were included for analysis.


METHODS
Oral itraconazole (200 mg twice daily), versus amphotericin B (0.3 mg/kg daily) intravenously plus oral flucytosine (150 mg/kg daily) was administered for 6 weeks followed by maintenance therapy with oral itraconazole (200 mg daily) to all patients.


METHODS
Outcome measures were a complete or partial response, recrudescence and relapse.


RESULTS
A complete response was observed in five out of the 12 patients who completed 6 weeks of initial treatment with itraconazole versus all 10 patients who completed treatment with amphotericin B plus flucytosine (P = 0.009). A partial response was observed in seven out of the 14 patients assigned to itraconazole. During maintenance therapy, recrudescence (n = 6) or relapse (n = 1) occurred in seven out of the 12 patients initially assigned to itraconazole, whereas two relapses occurred among nine patients initially treated with amphotericin B plus flucytosine (P = 0.22); recurrence of clinical symptoms was significantly related to a positive cerebrospinal fluid culture at 6 weeks (P = 0.003).


CONCLUSIONS
Itraconazole is less effective compared with amphotericin B plus flucytosine in achieving a complete response in initial therapy in AIDS patients with cryptococcal meningitis.
de Gans
J
J
Department of Neurology, Academic Medical Centre, Amsterdam, The Netherlands.
Portegies
P
P
Tiessens
G
G
Eeftinck Schattenkerk
J K
JK
van Boxtel
C J
CJ
van Ketel
R J
RJ
Stam
J
J
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000328:Adult; D000666:Amphotericin B / Q000008:administration & dosage / Q000627:therapeutic use; D000935:Antifungal Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005437:Flucytosine / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D017964:Itraconazole; D007654:Ketoconazole / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use; D008297:Male; D016919:Meningitis, Cryptococcal / Q000150:complications / Q000188:drug therapy*; D008875:Middle Aged; D009894:Opportunistic Infections / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D016019:Survival Analysis
D000935:Antifungal Agents; D017964:Itraconazole; D000666:Amphotericin B; D005437:Flucytosine; D007654:Ketoconazole