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

Primary Visceral Leishmaniasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067443
• Other study ID #: LEAP 0208
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2010
• Last updated: April 21, 2017
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: April 2017
• Source: Drugs for Neglected Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral
• Primary Visceral Leishmaniasis

Intervention

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
• 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
• Miltefosine
Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Locations

Country	Name	City	State
Kenya	Kimalel Health Centre	Kimalel
Sudan	El Hassan Centre for Tropical Medicine	Doka	Gedarif
Sudan	Kassab Hospital	Kassab	Gedaref

Sponsors (3)

Lead Sponsor	Collaborator
Drugs for Neglected Diseases	Gilead Sciences, Paladin Laboratories Inc

Countries where clinical trial is conducted

Kenya,  Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial cure: proportion cured at Day 28		Day 28
Secondary	Final cure: proportion cured at day 210		6 months post treatment
Secondary	Adverse events and serious adverse events occurring in the three study arms		up to day 60