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

NCT02011958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2019-04-08

No results posted yet for this study

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.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Liposomal Amphotericin B

40 mg/kg total dose: IV infusion of 5mg/kg per day on day 1 to 5, 10,17,24 (when administered as a monotherapy) 30 mg/kg total dose: IV infusion 5 mg/kg per day on day 1, 3, 5, 7, 9, 11 (when administered in combination with Miltefosine)

DRUG

Miltefosine

Orally taken every day during 28 days * 1 x 50 mg capsule per day if the patient weights less or equal to 25 kg * 2 x 50 mg capsules per day if the patient weights more than 25 kg (1 capsule in the morning / 1 capsule in the evening)

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Addis Ababa University

    collaborator OTHER

  • Institute of Tropical Medicine, Belgium

    collaborator OTHER

  • Slotervaart Hospital

    collaborator OTHER

  • University of Gondar

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Ermias Diro, Dr. MD · University of Gondar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-08-31
Completion
2017-09-15

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011958 on ClinicalTrials.gov