Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02011958
• Date of registration: 18/11/2013
• Prospective Registration: Yes
• Primary sponsor: Drugs for Neglected Diseases
• Public title: Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
• Scientific 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.
• Date of first enrolment: July 2014
• Target sample size: 59
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02011958
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Ethiopia

Contacts

• Name: Ermias Diro, Dr. MD
• Affiliation: University of Gondar

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Visceral Leishmaniasis

Intervention(s)

Drug: Liposomal Amphotericin B

Drug: Miltefosine

Primary Outcome(s)

Initial parasitological cure at day 29 [Time Frame: Day 29]

Secondary Outcome(s)

Relapse-free survival at day 390 [Time Frame: Day 390]

Secondary ID(s)

HIV/VL 0511

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Addis Ababa University

London School of Hygiene and Tropical Medicine

Medecins Sans Frontieres, Netherlands

University of Gondar

Institute of Tropical Medicine, Belgium

Slotervaart Hospital