A phase II dose-ranging study of sitamaquine for the treatment of visceral leishmaniasis in India.

Abstract

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.

• Authors: Tara K Jha, Shyam Sundar, Chandreshwar P Thakur, J Mark Felton, Antony J Sabin, John Horton
• Journal: The American journal of tropical medicine and hygiene (Am J Trop Med Hyg) Vol. 73 Issue 6 Pg. 1005-11 (Dec 2005) ISSN: 0002-9637 [Print] United States
• PMID: 16354802 (Publication Type: Clinical Trial, Phase II, Journal Article, Meta-Analysis, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Aminoquinolines
• Antiprotozoal Agents
• 8-aminoquinoline

Topics

• Administration, Oral
• Adolescent
• Adult
• Aminoquinolines (administration & dosage, adverse effects, therapeutic use)
• Antiprotozoal Agents (administration & dosage, adverse effects, therapeutic use)
• Child
• Drug Administration Schedule
• Female
• Humans
• India
• Leishmaniasis, Visceral (drug therapy, pathology)
• Male
• Middle Aged
• Treatment Outcome