Status:
COMPLETED
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
Visceral Leishmaniasis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 deploye...
Detailed Description
New, effective, less toxic and simplified treatments are urgently needed to replace or complement the few currently available drugs to treat visceral Leishmaniasis. An interim strategy and one which w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
634 Patients enrolled
Trial Details
Trial ID
NCT00696969
Start Date
June 1 2008
End Date
January 1 2010
Last Update
February 11 2010
Active Locations (2)
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1
Kala-azar medical centre
Muzaffarpur, Bihar, India
2
Rajendra Memorial research Institute
Patna, Bihar, India