Abstract | 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. CONCLUSION:
D0870 demonstrates excellent efficacy at low doses in the treatment of HIV-related OPC and exhibits a favourable safety profile.
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Authors | S De Wit, B Dupont, J D Cartledge, D A Hawkins, B G Gazzard, N Clumeck, D W Denning |
Journal | AIDS (London, England)
(AIDS)
Vol. 11
Issue 6
Pg. 759-63
(May 1997)
ISSN: 0269-9370 [Print] England |
PMID | 9143608
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antifungal Agents
- Triazoles
- ICI 195739
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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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