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Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa

This study has been completed.
Sponsor:
Collaborators:
Gilead Sciences
Paladin Laboratories Inc
Information provided by (Responsible Party):
Drugs for Neglected Diseases
ClinicalTrials.gov Identifier:
NCT01067443
First received: February 10, 2010
Last updated: April 21, 2017
Last verified: April 2017
  Purpose
This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.

Condition Intervention Phase
Primary Visceral Leishmaniasis
Drug: Liposomal amphotericin B (AmBisome®) and sodium stibogluconate
Drug: Liposomal amphotericin B + miltefosine
Drug: Miltefosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Primary Visceral Leishmaniasis in Eastern Africa

Resource links provided by NLM:


Further study details as provided by Drugs for Neglected Diseases:

Primary Outcome Measures:
  • Initial cure: proportion cured at Day 28 [ Time Frame: Day 28 ]

Secondary Outcome Measures:
  • Final cure: proportion cured at day 210 [ Time Frame: 6 months post treatment ]
  • Adverse events and serious adverse events occurring in the three study arms [ Time Frame: up to day 60 ]

Enrollment: 151
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amb+SSG
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11
Drug: Liposomal amphotericin B (AmBisome®) and sodium stibogluconate
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11
Experimental: Amb+Milt
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11
Drug: Liposomal amphotericin B + miltefosine
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11
Experimental: Milt
Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28
Drug: Miltefosine
Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Detailed Description:
The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.
  Eligibility

Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
  • Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
  • Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
  • HIV negative status

Exclusion Criteria:

  • Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
  • Patients with a negative lymph node/bone marrow (or spleen) smears.
  • Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI </= 15, Children W/H<70, presence of oedema)
  • Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
  • Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication.
  • Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
  • Patients with previous history of cardiac arrhythmia or an abnormal ECG
  • Patients who are female of child bearing age (all females who have achieved menarche) / pregnant or lactating.
  • Patients with haemoglobin < 5gm/dl.
  • Patients with WBC < 1 x 10³/mm³.
  • Patients with platelets < 40,000/mm³.
  • Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
  • Patients with serum creatinine outside the normal range for age and gender.
  • Major surgical intervention within 2 weeks prior to enrolment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067443

Locations
Kenya
Kimalel Health Centre
Kimalel, Kenya
Sudan
Kassab Hospital
Kassab, Gedaref, Sudan
El Hassan Centre for Tropical Medicine
Doka, Gedarif, Sudan
Sponsors and Collaborators
Drugs for Neglected Diseases
Gilead Sciences
Paladin Laboratories Inc
Investigators
Principal Investigator: Monique Wasunna, MD Kenya Medical Research Institute
  More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Final Study Protocol

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT01067443     History of Changes
Other Study ID Numbers: LEAP 0208
Study First Received: February 10, 2010
Last Updated: April 21, 2017

Keywords provided by Drugs for Neglected Diseases:
Phase II
Randomised clinical trial
Visceral Leishmaniasis

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Miltefosine
Liposomal amphotericin B
Amphotericin B
Antimony Sodium Gluconate
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents
Amebicides
Anti-Bacterial Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on May 25, 2017