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A PHASE II DOSE-INCREASING STUDY OF SITAMAQUINE FOR THE TREATMENT OF VISCERAL LEISHMANIASIS IN KENYA

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.

Received January 28, 2005. Accepted for publication July 19, 2005.

Acknowledgments: We thank all the clinical, technical, and nursing staff at the Centre for Clinical Research for their support and the patients who took part in this study. This manuscript is published with permission from the Director, Kenya Medical Research Institute.

Financial support: This work was supported by GlaxoSmithKline and the Kenya Medical Research Institute.

Disclosure: J. Mark Felton and Antony J. Sabin are employees of GlaxoSmithKline. This statement is being made in the interest of full disclosure and not because the authors consider this to be a conflict of interest.

^* Address correspondence to J. Mark Felton, GlaxoSmithKline, Greenford Road, Greenford, Middlesex UB6 0HE, United Kingdom. E-mail: mark.j.felton{at}gsk.com

Authors’ addresses: Monique K. Wasunna, Juma R. Rashid, Jane Mbui, George Kirigi, Dedan Kinoti, and Hudson Lodenyo, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya, Telephone: 254-20-272-6781, Fax: 254-20-272-0030, E-mail: mkwasunna{at}yahoo.com. J. Mark Felton and Antony J. Sabin, Glaxo-SmithKline, Greenford Road, Greenford, Middlesex UB6 0HE, United Kingdom, Telephone: 44-208-966-8004, Fax: 44-208-966-3674, E-mails: mark.j.felton{at}gsk.com and antony.j.sabin{at}gsk.com. John Horton, 24 The Paddock, Hitchin, Herts SG4 9EF, United Kingdom, E-mail: hedgepigs{at}aol.com.

Reprint requests: Monique K. Wasunna, Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.

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