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Sponsored by: |
Banaras Hindu University |
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Information provided by: | Banaras Hindu University |
ClinicalTrials.gov Identifier: | NCT00629031 |
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.
Condition | Intervention | Phase |
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Visceral Leishmaniasis |
Drug: Paromomycin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Enrollment: | 329 |
Study Start Date: | February 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
Paromomycin for 21 days @ 11mg/kg
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Drug: Paromomycin
Paromomycin for 21 days @ 11mg/kg by intramuscular injections
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1: Experimental
Paromomycin for 14 days @ 11mg/kg
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Drug: Paromomycin
11 mg/kg for 14 days
Drug: Paromomycin
Paromomycin for 21 days @ 11mg/kg by intramuscular injections
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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:
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.
Ages Eligible for Study: | 5 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Creatinine > 3 times
Responsible Party: | Banaras Hindu University ( Shyam Sundar ) |
Study ID Numbers: | KAMRC PSD |
Study First Received: | February 20, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00629031 |
Health Authority: | India: Ministry of Health |
Visceral leishmaniasis Paromomycin |
Leishmaniasis Protozoan Infections Skin Diseases, Infectious Skin Diseases |
Parasitic Diseases Leishmaniasis, Visceral Paromomycin |
Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Skin Diseases, Parasitic |
Therapeutic Uses Sarcomastigophora Infections Mastigophora Infections Amebicides Pharmacologic Actions |