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

• Published in: The American journal of tropical medicine and hygiene Vol. 73; no. 6; pp. 1005 - 1011
• Main Authors: JHA, TARA K, SUNDAR, SHYAM, THAKUR, CHANDRESHWAR P, FELTON, J. MARK, SABIN, ANTONY J, HORTON, JOHN
• Format: Journal Article
• Language: English
• Published: Lawrence, KS ASTMH 01.12.2005; Allen Press
• Subjects: Administration, Oral; Adolescent; Adult; Aminoquinolines - administration & dosage; Aminoquinolines - adverse effects; Aminoquinolines - therapeutic use; Antiprotozoal Agents - administration & dosage; Antiprotozoal Agents - adverse effects; Antiprotozoal Agents - therapeutic use; Biological and medical sciences; Child; Drug Administration Schedule; Female; Human protozoal diseases; Humans; India; Infectious diseases; Leishmaniasis, Visceral - drug therapy; Leishmaniasis, Visceral - pathology; Leshmaniasis; Male; Medical sciences; Middle Aged; Parasitic diseases; Protozoal diseases; Treatment Outcome; Asia; India; Human; Protozoal disease; Kala azar; Leishmaniasis; Parasitosis; Posology; Infection; Antiprotozoal agent; Chemotherapy; Sitamaquine; Treatment; Phase II trial; Parasiticide; Tropical medicine; Dose
• ISSN: 0002-9637; 1476-1645
• DOI: 10.4269/ajtmh.2005.73.1005

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.