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

• Status: Completed
• Trial end date: 2017-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborators: Addis Ababa University; Institute of Tropical Medicine, Belgium; London School of Hygiene and Tropical Medicine; Medecins Sans Frontieres, Netherlands; Slotervaart Hospital; University of Gondar
• Treatments: Amphotericin B; Liposomal amphotericin B; Miltefosine; Pentamidine

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