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| Paromomycin as a New Cure for Visceral Leishmaniasis: Initial Results of a Phase III Multicenter, Randomized, Controlled, Clinical Trial to Assess Safety and Efficacy |
| Category:
Clinical Tropical Medicine |
| Presentation Time: Monday, 1:45 p.m. - 2:00 p.m. |
V. Hale1, A. Herskowitz1, S. K. Battacharya2, T. K. Jha3, S. Sundar4, C. P. Thakur5, F. Espino6, J. Karbwang6, M. McGuffey1, C. Ley1
1Institute for OneWorld Health, San Francisco, CA, United States, 2Rajendra Memorial Research Institute, Patna, India, 3Kalazar Research Centre, Muzzafarpur, India, 4Kala-azar Medical Research Centre, Muzzafarpur, India, 5Kalazar Research Centre, Patna, India, 6WHO Tropical Disease Research, Geneva, Switzerland |
| Presentation Number: 48 |
| Keyword:
paromomycin, visceral leishmaniasis, clinical trial |
| Visceral leishmaniasis (VL) is a commonly fatal parasitic disease affecting 500,000 people annually, primarily in India, Bangladesh, Nepal, Sudan and Brazil. Current treatment options are toxic or expensive; anti-parasitic drugs are increasingly ineffective. The non-profit pharmaceutical Institute for OneWorld Health is developing the off-patent aminoglycoside paromomycin as a new, safe, effective, inexpensive cure for VL. A phase 3, randomized clinical trial is being completed at 4 sites in Bihar, India. Aims are to determine the safety of paromomycin compared to amphotericin B and its efficacy at 1 and 6 months after end of treatment. Patients aged 5-55 years with confirmed VL consented to audiometric, HIV and pregnancy testing. Eligible patients were randomized in a 3:1 ratio to receive paromomycin (IM, 15 mg/kg/day for 21 days) or amphotericin B (IV, 1 mg/kg/every other day for 30 days). A total of 667 patients (502 paromomycin, 165 amphotericin B) was enrolled from 6/2003 to 4/2004. Rates of death, withdrawal and overall adverse events (AE) were similar between drugs (paromomycin: 1%, 0.4%, 64%; amphotericin B: 1%, 1%, 67%). However, the mean number of AEs and concomitant medication use were statistically significantly decreased for paromomycin compared to amphotericin B (mean AE number: 1.2 vs. 4.1; medication use: 22% vs. 80%). Primary AEs for paromomycin included pain at injection site (87%) and for amphotericin B, fever/chills/rigor/vomiting (94%). Reversible ototoxocity at 10-12 KHz was observed in 2 paromomycin patients; nephrotoxicity was observed for amphotericin B only (n=1). 6 month follow-up will be completed in 11/2004; 4 week cure rates were 98% for both drugs. In conclusion, initial results suggest that paromomycin is a safe and effective cure for VL in India. |
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