Primary Visceral Leishmaniasis
Conditions
Keywords
Phase II, Randomised clinical trial, Visceral Leishmaniasis
Brief 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.
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.
Interventions
DRUGLiposomal 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
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
DRUGMiltefosine
Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28
Sponsors
Gilead Sciences
Paladin Labs Inc.
Drugs for Neglected Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Initial cure: proportion cured at Day 28 | Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Final cure: proportion cured at day 210 | 6 months post treatment |
| Adverse events and serious adverse events occurring in the three study arms | up to day 60 |
Countries
Kenya, Sudan
Outcome results
None listed