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A dose comparison study of a new triazole antifungal (D0870) in HIV-positive patients with oral candidiasis.

AbstractOBJECTIVE:
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.
CONCLUSION:
D0870 demonstrates excellent efficacy at low doses in the treatment of HIV-related OPC and exhibits a favourable safety profile.
AuthorsS De Wit, B Dupont, J D Cartledge, D A Hawkins, B G Gazzard, N Clumeck, D W Denning
JournalAIDS (London, England) (AIDS) Vol. 11 Issue 6 Pg. 759-63 (May 1997) ISSN: 0269-9370 [Print] England
PMID9143608 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Antifungal Agents
  • Triazoles
  • ICI 195739
Topics
  • AIDS-Related Opportunistic Infections (drug therapy, microbiology)
  • Adolescent
  • Adult
  • Antifungal Agents (blood, pharmacology)
  • Candida (drug effects, isolation & purification)
  • Candida albicans (drug effects, isolation & purification)
  • Candidiasis
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Mouth Diseases (drug therapy, microbiology)
  • Recurrence
  • Treatment Outcome
  • Triazoles (blood, pharmacology)

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