Abstract |
Sitamaquine ( WR6026) is an 8-aminoquinoline in development for the oral treatment of visceral leishmaniasis (VL). This was an open-label, dose-increasing study to determine the dose-response and safety profile for sitamaquine in Kenyan patients with VL caused by Leishmania donovani. Patients (mean age 15.9 [range = 5-47] years) received sitamaquine daily for 28 days at one of four doses: 1.75 (n = 12), 2.0 (n = 61), 2.5 (n = 12), or 3.0 (n = 12) mg/kg/day. The primary efficacy outcome was cure (absence of parasites on splenic aspirate) in the intent-to-treat population at day 180. Cure was achieved in 79 (83%) of 95 patients overall, and in 11 (92%) of 12, 49 (80%) of 61, 9 (82%) of 11, and 10 (91%) of 11 patients at sitamaquine doses of 1.75, 2.0, 2.5, or 3.0 mg/kg/day, respectively. The most frequent adverse events during active treatment were abdominal pain (12 [12%] of 97) and headache (11 [11%] of 97), and one patient in each of the 2.5 mg/kg/day and 3.0 mg/kg/day dose groups had a severe renal adverse event. The effects of sitamaquine on the kidney need further investigation. Sitamaquine was efficacious and generally well tolerated in Kenyan patients with VL.
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Authors | Monique K Wasunna, Juma R Rashid, Jane Mbui, George Kirigi, Dedan Kinoti, Hudson Lodenyo, J Mark Felton, Antony J Sabin, M John Albert, John Horton |
Journal | The American journal of tropical medicine and hygiene
(Am J Trop Med Hyg)
Vol. 73
Issue 5
Pg. 871-6
(Nov 2005)
ISSN: 0002-9637 [Print] United States |
PMID | 16282296
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aminoquinolines
- Antiprotozoal Agents
- 8-aminoquinoline
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Topics |
- Adolescent
- Adult
- Aged
- Aminoquinolines
(administration & dosage, adverse effects, therapeutic use)
- Animals
- Antiprotozoal Agents
(administration & dosage, adverse effects, therapeutic use)
- Child
- Child, Preschool
- Cohort Studies
- Dose-Response Relationship, Drug
- Female
- Humans
- Kenya
- Leishmania donovani
(drug effects)
- Leishmaniasis, Visceral
(drug therapy, parasitology)
- Male
- Middle Aged
- Treatment Outcome
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