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

Condition(s) targeted: Primary Visceral Leishmaniasis

Intervention: Liposomal amphotericin B (AmBisome®) and sodium stibogluconate (Drug); Liposomal amphotericin B + miltefosine (Drug); Miltefosine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Drugs for Neglected Diseases

Official(s) and/or principal investigator(s):
Monique Wasunna, MD, Principal Investigator, Affiliation: Kenya Medical Research Institute

Overall contact:
Monique Wasunna, MD, Email: africa@dndi.org

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Initial cure: proportion cured at Day 28

Secondary outcome:

Final cure: proportion cured at day 210

Adverse events and serious adverse events occurring in the three study arms

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.

Minimum age: 7 Years. Maximum age: 60 Years. Gender(s): Both.

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 - 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.

Monique Wasunna, MD, Email: africa@dndi.org

Kimalel Health Centre, Kimalel, Kenya; Recruiting
Njenga Njoroge
Njenga Njoroge, Principal Investigator

Kassab Hospital, Kassab, Gedaref, Sudan; Not yet recruiting
Abuzaid Abdallah, MD, Email: abuzaidabdalla@yahoo.com
Ahmed Musa, MD, Email: musaam2003@yahoo.co.uk
Abuzaid Abdallah, MD, Principal Investigator

El Hassan Centre for Tropical Medicine, Doka, Gedarif, Sudan; Recruiting
Ahmed Musa, Email: musaam2003@yahoo.co.uk
Brima Musa, Email: brimamusa@hotmail.com
Abuzaid A Abdalla, Sub-Investigator

Starting date: March 2010
Last updated: March 9, 2011