Health Condition 1: B550- Visceral leishmaniasis Health Condition 2: null- Visceral Leishmaniasis (VL), also known as Kala Azar, in patients with HIV infection
Conditions
Interventions
Intervention1: Liposomal Amphotericin B (AmBisome®): AmBisome® mono therapy - infusion 40mg/kg liposomal amphotericin B (5mg/kg on day 1-4,8,10,17,24).
Intervention2: Liposomal Amphotericin B (AmBis
Sponsors
Medecins Sans Frontieres
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: Confirmed HIV positive test (2 rapid diagnostics tests (RDTs) as per National Programme guidelines, WB for any discrepancy Diagnosis of VL confirmed by bone marrow or spleen aspirate. Male and female age >= 18 years Written informed consent from the patient.
Exclusion criteria
Exclusion criteria: Women of child-bearing potential who are not using an assured method of contraception or are unwilling to use an assured method of contraception for the duration of treatment and three months after. Pregnant women or breast-feeding mothers. Clinical or biological evidence of severe cardiac, renal or hepatic impairment. Known hypersensitivity to AmBisome® and/or miltefosine. Concomitant severe infection such as TB or other serious underlying disease that would preclude evaluation of patients response to study medication Hb Abnormal liver function tests (ALT/AST) more than 3 times the upper limit of normal Creatinine >1.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is cure at day 210 and is defined as survival and being symptom free of VL at day 210.Timepoint: Day 210 | — |
Secondary
| Measure | Time frame |
|---|---|
| Initial cure at Day 29 as defined as: Patient presents clinical improvement, defined as cessation of fever and reduction in any initial splenomegaly and a negative parasitological assessment by tissue aspirate.Timepoint: Day 29;Relapse-free survival at 12 months as defined as: - The patient being alive and symptom-free from day 210 (if initially cured) and remains symptom-free until the last follow up assessment (i.e. day 390). Timepoint: Day 390;Relapse-free survival of patients with no concurrent TB infection at 6 and 12 months defined as: The patient has no diagnosis of TB prior to day 58 and is alive and disease-free (defined as absence of signs and symptoms of VL or if symptomatic, a negative parasitological assessment by tissue aspirate) at day 210 and remains disease free and alive from day 210 (if initially cured) until the last follow up assessment (i.e. day 390).Timepoint: Day 210 and Day 390;Safety Assessment of safety during treatment and follow-up based on clinical adverse events, laboratory parameters during treatment and 1 month follow up.Timepoint: Up to day 58 | — |
Countries
India
Contacts
Public ContactDr Sakib Burza
Medecins Sans Frontieres
Outcome results
None listed