Visceral Leishmaniasis Clinical Trial
Official title:
A Randomized Trial of Ambisome Monotherapy and Combination of Ambisome and Miltefosine for the Treatment of VL in HIV Positive Patients in Ethiopia Followed by Secondary VL Prophylactic Treatment With Pentamidine.
Verified date | April 2019 |
Source | Drugs for Neglected Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall objective of this trial is to identify a safe and effective treatment for
visceral leishmaniasis (VL) in HIV co-infected Ethiopian patients.
Patients will receive either Ambisome alone or Ambisome in combination with Miltefosine.
Patients who do not undergo treatment failure will be given a VL prophylactic treatment with
Pentamidine one month after the end of the study treatment.
Status | Completed |
Enrollment | 59 |
Est. completion date | September 15, 2017 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Confirmed HIV positive test (2 rapid diagnostics tests (RDTs) followed by a confirmatory ELISA test). - Diagnosis of VL (first episode or relapse) confirmed by bone marrow or spleen aspirate. - Male and female age: 18-60 years. - Written informed consent from the patient. Exclusion Criteria: - Women of child-bearing potential (defined as women who have achieved menarche) 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 four months after. - Pregnant women or breast-feeding mothers. - Patients with grade 2 or 3 post kala-azar dermal leishmaniasis (PKDL) lesions. - Clinical or biological evidence of severe cardiac, renal or hepatic impairment. - Known hypersensitivity to AmBisome® and/or miltefosine. - Patients receiving allopurinol treatment |
Country | Name | City | State |
---|---|---|---|
Ethiopia | MSF | Abdurafi | |
Ethiopia | Leishmaniasis Research Center, University Hospital of Gondar | Gondar |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases | Addis Ababa University, Institute of Tropical Medicine, Belgium, London School of Hygiene and Tropical Medicine, Medecins Sans Frontieres, Netherlands, Slotervaart Hospital, University of Gondar |
Ethiopia,
Diro E, Blesson S, Edwards T, Ritmeijer K, Fikre H, Admassu H, Kibret A, Ellis SJ, Bardonneau C, Zijlstra EE, Soipei P, Mutinda B, Omollo R, Kimutai R, Omwalo G, Wasunna M, Tadesse F, Alves F, Strub-Wourgaft N, Hailu A, Alexander N, Alvar J. A randomized — View Citation
Diro E, Edwards T, Ritmeijer K, Fikre H, Abongomera C, Kibret A, Bardonneau C, Soipei P, Mutinda B, Omollo R, van Griensven J, Zijlstra EE, Wasunna M, Alves F, Alvar J, Hailu A, Alexander N, Blesson S. Long term outcomes and prognostics of visceral leishm — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety endpoint | Adverse Events and Serious Adverse Events | From the first dose of study medication up to 1 month after the stop of treatment | |
Other | Response to antiretroviral treatment | Measurement of CD4 (cluster of differentiation 4) count and HIV viral load | Screening , Day 29, Day 58, Day 210 and Day 390 | |
Other | Pharmacokinetics: drug-drug interaction between VL treatment and antiretroviral drugs (Arm 1: PK AmphoB (Amphotericin B) and PK/EFV (Efavirenz)/NVP (Nevirapine)/LPV (Lopinavir)/RTV, Arm 2: PK AmphoB, PK Miltefosine and PK EFV/NVP/LPV/RTV) | In a subgroup of patients, blood concentrations of Ambisome (EDTA plasma), Miltefosine (DBS) and Anti Retroviral Drugs (DBS) | Arm1:PK AmphoB, Day 1 and 24 post-dose / PK EFV/NVP/LPV/RTV: Day 1,24,58,210 and 390 post-dose. Arm 2: PK AmphoB, Day 1 and 11 post-dose/PK Miltefosine: Pre-dose, day 11,29,58,210 post-dose / PK EFV/NVP/LPV/RTV: Day 1,29,58,210 and 390 post-dose | |
Primary | Initial parasitological cure at day 29 | Absence of parasites in tissue aspirate at day 29; hence no rescue medication provided up to this time-point. | Day 29 | |
Secondary | Relapse-free survival at day 390 | The patient being alive and disease free from day 29 (if initially cured) or day 58 in case of extended treatment (absence of signs and symptoms of visceral leishmaniasis or if symptomatic, a negative parasitological assessment by tissue aspirate) | Day 390 |
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