Phase 4 Trial of Miltefosine for the Treatment of Indian Visceral Leishmaniasis

Bhattacharya, Sujit Kumar; Sinha, Prabhat Kumar; Sundar, Shyam; Thakur, Chandreshar Prasad; Jha, Tara Kant; Pandey, Krishna; Das, Vidyanand Rabi; Kumar, Naveen; Lal, Chandrasekhar; Verma, Neena; Singh, Vijay Pratap; Ranjan, Alok; Verma, Rakesh Bihari; Anders, Gerlind; Sindermann, Herbert; Ganguly, Nirmal Kumar
August 2007
Journal of Infectious Diseases;8/15/2007, Vol. 196 Issue 4, p591
Academic Journal
Background. Visceral leishmaniasis (VL) is a major public health problem in Bihar, accounting for 90% of all cases in India. Development of high levels of resistance to various existing drugs necessitated the search for alternative orally administered drugs. Hospital-based studies have shown that oral miltefosine is a highly effective treatment for VL both in adults and in children. Methods. An open, single-arm trial was designed to investigate the feasibility of treatment of VL patients with miltefosine in field conditions in 13 centers in Bihar. Results. The phase 4 study was conducted among 1132 adult and pediatric VL patients. Compliance was good, with 1084 (95.5%) patients completing the full 28-day treatment course. Nine hundred and seventy-one (85.8%) patients returned for the final cure assessment at 6 months after treatment. The final cure rate was 82% by intention to treat analysis and 95% by per protocol analysis (similar to the 94% cure rate in hospitalized patients). Treatmentrelated adverse events of common toxicity criteria grade 3 occurred in ∼3% of patients, including gastrointestinal toxicity and rise in aspertate amino transferase, alanine amino transferase, or serum creatinine levels, similar to previous clinical experience. Conclusion. This study supports the use of miltefosine in an outpatient setting in an area where VL is endemic.


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