Clinical Trial: A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Single Center, Open-Label, Dose-Escalation Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Treatment Naïve Or Resistant Cases Of

Brief Summary:

The purpose of this study is:

  1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations.
  2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.

Detailed Summary:

  1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations.
  2. To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar.

Subjects will be administered the study drug in either of the following four dose levels in an ascending manner, starting with the first dosage regimen:

  • 7.5 mg/kg on day 1 and day3 (Regimen 1)
  • 10 mg/kg on day 1, followed by 5 mg/kg on day 3 (Regimen 2)
  • 12.5 mg/kg on day 1, followed by 2.5 mg/kg on day 3 (Regimen 3)
  • Single-bolus infusion of 15 mg/kg over 2-4 hours on day 1 (Regimen 4)

Sponsor: Banaras Hindu University

Current Primary Outcome: Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months, no hematological, hepatic or renal toxicity [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Banaras Hindu University

Dates:
Date Received: July 5, 2007
Date Started: February 2007
Date Completion:
Last Updated: September 11, 2008
Last Verified: September 2008