NCT00629031

An Open Lable Randomised Study to Assess the Safety and Efficacy of Short Course Paromomycin in Visceral Leishmaniasis

An Open Lable Randomised Two -Arm Study to Assess the Safety and Efficacy of Paromomycin Administered Intramuscularly at Two Different Dosing Regimens (14 Days Versus 21 Days) for the Treatment of Indian Visceral Leishmaniasis (VL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Banaras Hindu University · Academic / Other
• Sex: All
• Age: 5 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

It is a randomized, double-blind, multi-center, two-arm study intended to assess the safety and efficacy of three different doses/dose regimens of paromomycin administered intramuscularly as follows: 11 mg/kg/day for 14 days and 11 mg/kg/day for 21 days for the treatment of visceral leishmaniasis (VL) in India.

Detailed description

Paromomycin administered at a dose of 11 mg/kg/day IM for 21 days was previously demonstrated by iOWH and WHO to be as effective as amphotericin B administered IV at a dose of 1 mg/kg/every other day for a total for a total of 15 doses over 30 days in the treatment of VL in Bihar, India (protocol VLPM01) in a recently completed study (94.6% vs. 98.8% of subjects were disease free at 6 months, respectively). This new study is being conducted to determine whether similar or better efficacy and safety of IM paromomycin can be achieved with a shorter duration of treatment (14 days rather than 21 days) administered for a shorter duration (14 days rather than 21 days) than the regimen studied in the previous trial. This shorter duration study will compare the initial and final cure (response to treatment) rates in subjects with VL receiving paromomycin at the following doses and dose regimens: * Group A: paromomycin 11 mg/kg/day IM for 14 days * Group B: paromomycin 11 mg/kg/day IM for 21 days Because compliance generally improves with shorter duration of therapy, and better treatment compliance decreases the probability of the emergence of drug-resistant disease, administration of higher daily doses of paromomycin for a shorter time may improve efficacy without producing unacceptable toxicity. In addition, a treatment regimen of shorter duration would cost less and be easier to administer. The current study is designed to explore different doses and dose regimens of IM paromomycin to determine the dose and dose regimen that should be recommended for first-line therapy for treatment of VL, while maintaining the efficacy and safety.

Conditions

• Visceral Leishmaniasis

Interventions

Type	Name	Description
DRUG	Paromomycin	11 mg/kg for 14 days
DRUG	Paromomycin	Paromomycin for 21 days @ 11mg/kg by intramuscular injections

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-02-01
• Completion: 2008-08-01
• First posted: 2008-03-05
• Last updated: 2008-09-12

Locations

1 site across 1 country: India