Visceral Leishmaniasis Clinical Trial
Official title:
Randomized, Open-label, Parallel-group, Safety & Efficacy Study to Evaluate Different Combination Treatment Regimens, of Either AmBisome and Paromomycin, AmBisome and Miltefosine, or Paromomycin and Miltefosine Compared With Amphotericin B Deoxycholate (the Standard) Therapy for the Treatment of Acute, Symptomatic Visceral Leishmaniasis (VL).
Verified date | February 2010 |
Source | Drugs for Neglected Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Drugs Controller General of India |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 634 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Kala-azar medical centre | Muzaffarpur | Bihar |
India | Rajendra Memorial research Institute | Patna | Bihar |
Lead Sponsor | Collaborator |
---|---|
Drugs for Neglected Diseases |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Definitive cure based on parasitological clearance at Day 15 after start of combination therapy (Day 31 for standard therapy), no evidence of parasites at day 45 and no clinical signs or symptoms of VL at 6 months post treatment. | 6 months post treatment | No |
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