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A PHASE II DOSE-RANGING STUDY OF SITAMAQUINE FOR THE TREATMENT OF VISCERAL LEISHMANIASIS IN INDIA

This randomized, open label, multicenter study assessed the dose-response and safety profile for oral sitamaquine in 120 Indian subjects with visceral leishmaniasis (VL). Patients aged 5–64 years (mean age 21.2 years) received one of four sitamaquine doses (1.5, 1.75, 2.0, or 2.5 mg kg^–1 day^–1) daily for 28 days. At Day 180 in the intent-to-treat population, final cure (primary efficacy outcome) was achieved in 92 of 106 (87%) patients overall and 25 of 31 (81%), 24 of 27 (89%), 23 of 23 (100%), and 20 of 25 (80%) patients at doses of 1.5, 1.75, 2.0, or 2.5 mg kg^–1 day^–1 sitamaquine, respectively. Sitamaquine was generally well tolerated. The most common adverse events during the active treatment phase were vomiting (8% [10 of 120]), dyspepsia (8% [9 of 120]) and cyanosis (3% [4 of 120]). Nephrotic syndrome (3% [3 of 120]) and glomerulonephritis (2% [2 of 120]) were also reported and require further investigation. Oral sitamaquine demonstrated efficacy in Indian VL and was well tolerated.

Received January 28, 2005. Accepted for publication June 7, 2005.

Financial support: This clinical study was sponsored by GlaxoSmith-Kline, Greenford, UK.

Disclosures: A. J. Sabin wishes to disclose that he is an employee of GlaxoSmithKline. C. P. Thakur wishes to disclose that the drug came for trial at three centers, and Balaji Uthan Sansthan was one of the centers. J. M. Felton wishes to disclose that he is an employee of GlaxoSmithKline and also holds shares in the company. These statements are 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, UK. E-mail: Mark.J.Felton{at}gsk.com

Authors’ addresses: Tara K. Jha, Kala-azar Medical Research Center, Rambag Road, Muzaffarpur, 842 001, India. Shyam Sundar, Kala-azar Medical Research Center, 6 SK Gupta Nagar, Lanka, Banaras Hindu University, Varanasi, 221 005, India. Chandreshwar P. Thakur, Balaji Uthan Sansthan, Fraser Road, Patna, 800 001, India. J. Mark Felton and Antony J. Sabin, GlaxoSmithKline, Greenford Road, Greenford, Middlesex, UB6 0HE, UK. John Horton, 24 The Paddock, Hitchin, Herts, SG4 9EF, UK.

Drs. Jha, Sundar, and Thakur contributed equally to this study.

Reprint requests: Tara K. Jha, Kala-azar Research Center, Muzaffarpur, 842 001 India, Telephone: 91-621-261-283, Fax: 91-621-261-425, E-mail: dr_tkjha{at}hotmail.com.

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