A dose comparison study of a new triazole antifungal (D0870) in HIV-positive patients with oral candidiasis.
OBJECTIVE
This multicentre study evaluated the clinical efficacy and tolerability of D0870 in treating oropharyngeal candidiasis in HIV-positive patients who had no history of clinical resistance to fluconazole.


METHODS
Three regimens were evaluated in two phases. In phase I a 50 mg initial dose was followed by 10 mg for 4 days (Group 1). In phase II a 100 mg initial dose was followed by 25 mg for 4 days (Group 2), or 10 mg for 5 days (Group 3).


RESULTS
Clinical cure was obtained in 27 patients of a total of 35 (77%) and six other patients improved (17%). Two patients at the lowest dose failed and both had very low plasma concentration of D0870. No association was found between clinical outcome; minimum inhibitory concentration of D0870 pre-therapy for Candida albicans, maximum recorded plasma D0870 concentration, cfu of culture or CD4 cell count at entry. Overall, 37% of the patients experienced relapse during the 2 weeks post therapy. Tolerance was excellent. Mild adverse events possibly related to the study drug were recorded in five patients.


CONCLUSIONS
D0870 demonstrates excellent efficacy at low doses in the treatment of HIV-related OPC and exhibits a favourable safety profile.
De Wit
S
S
Saint-Pierre Hospital, Brussels, Belgium.
Dupont
B
B
Cartledge
J D
JD
Hawkins
D A
DA
Gazzard
B G
BG
Clumeck
N
N
Denning
D W
DW
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000382:microbiology; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000097:blood / Q000494:pharmacology*; D002175:Candida / Q000187:drug effects / Q000302:isolation & purification; D002176:Candida albicans / Q000187:drug effects / Q000302:isolation & purification; D002177:Candidiasis; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009059:Mouth Diseases / Q000188:drug therapy* / Q000382:microbiology; D012008:Recurrence; D016896:Treatment Outcome; D014230:Triazoles / Q000097:blood / Q000494:pharmacology*
D000935:Antifungal Agents; D014230:Triazoles; C058219:ICI 195739