Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of this trial is to identify a safe and effective combination, (coadministration) short course treatment for the treatment of visceral leishmaniasis which could be easily deployed in a control programme and will reduce the risk of parasite resistance occurring.

Safety and tolerability should be such that the combination can be easily deployed.

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

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Treatments: Amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid; Liposomal amphotericin B; Miltefosine; Paromomycin

Criteria

Inclusion Criteria:

• Adults ( male or female) 18-60 years of age

• Acute, symptomatic, non-severe (minimum Hb.5 gm/dL) VL proven by parasitological examination of splenic or bone marrow aspirate.

• History of fever.

• Living within reachable distance of the trial site to enable attendance for follow-up visits

• Written informed consent to participate

• Proven HIV negative status

• Women of child-bearing potential who are using an assured method of contraception

Exclusion Criteria:

• Signs/symptoms indicative of severe VL ( Hb.< 5gm/dl, evidence of cardiac failure, etc)

• Patients who have received anti-leishmanial or anti-fungal treatment within the last 45 days

• Patients who have received any investigational (unlicensed) drugs within the last 6 months

• Severe malnutrition BMI<15 in adults, weight for height less than 60% in children.

• Chronic underlying disease such as severe cardiac, renal, or hepatic impairment.

• Renal function tests (serum creatinine) outside the normal range

• Liver function tests (transaminases) more than three times the upper limit of the normal range at study entry

• Jaundice (bilirubin >2.0mg/dL)

• Known hepatitis B or C positive

• Platelet count less than 40,000/mm3

• Prothrombin time 5 seconds or greater than normal range

• TotalWBC < 1,000/mm3

• Known alcohol or other drug abuse

• HIV positive status

• Pregnancy and/or lactation

• Females having unprotected sexual intercourse, or using a non-assured method of contraception (e.g. condom)

• Concomitant chronic drug treatment eg for diabetes, hypertension, TB, HIV etc

• Concomitant drug usage for acute infection, eg malaria, pneumonia etc within the last 7 days

• Any other condition which may invalidate the trial

• Known hypersensitivity to AmBisome, Paromomycin, amphotericin B and/or Miltefosine