Phase 2 trial of WR6026, an orally administered 8-aminoquinoline, in the treatment of visceral leishmaniasis caused by Leishmania chagasi.
Am J Trop Med Hyg
; 65(6): 685-9, 2001 Dec.
Article
en En
| MEDLINE
| ID: mdl-11791957
ABSTRACT
There are no recognized orally administered treatments for any of the leishmaniases. The 8-aminoquinoline WR6026 is an orally administered analog of primaquine that cured 50% of patients with kala-azar in Kenya at a dose of 1 mg/kg/day for 28 days. A further phase 2, open-label, dose-escalating safety and efficacy study was performed for kala-azar in Brazil. Cure rates for Brazilian patients treated for 28 days were as follows 1 mg/kg/day 0 of 4 (0%); 1.5 mg/kg/day 1 of 6 (17%); 2.0 mg/kg/day 4 of 6 (67%); 2.5 mg/kg/day 1 of 5 (20%); and 3.25 mg/kg/day 0 of 1 (0%). Nephrotoxicity that was not anticipated from preclinical animal studies or from phase 1 studies was seen at 2.5 mg/kg/day in 2 patients and in the single patient administered 3.25 mg/kg/day. WR6026 demonstrated the unusual clinical features of lack of increased efficacy against Brazilian kala-azar with increased dosing above 2 mg/kg/day and toxicity that was not present in previous investigations.
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Bases de datos:
MEDLINE
Asunto principal:
Aminoquinolinas
/
Leishmaniasis Visceral
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Antiprotozoarios
Límite:
Adolescent
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Adult
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Animals
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Child
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Am J Trop Med Hyg
Año:
2001
Tipo del documento:
Article
País de afiliación:
Brasil