Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
NCT ID: NCT00004755
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
375 participants
INTERVENTIONAL
1995-09-30
Brief Summary
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Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.
Detailed Description
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This is a randomized study. Patients are stratified by participating institution.
One group is treated with daily intramuscular injections of glucantime. Patients with less than a complete response on Day 21 continue treatment until lesions heal completely or for a maximum of 60 days. Patients with progressive disease on Day 40 are removed from study.
The second group is treated with daily oral allopurinol. Patients with a partial response on Day 21 continue treatment until lesions heal completely. Patients with stable or progressive disease on Day 21 or unhealed lesions on Day 56 cross to glucantime therapy. Accrual into this group was closed in 6/96.
The third group receives allopurinol and glucantime.
Patients are followed at 3, 6, and 9 months, then annually for at least 5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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allopurinol
glucantime
Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics--
Parasitologically confirmed cutaneous leishmaniasis (lesion of less than 3 months duration)
No mucocutaneous leishmaniasis
No prior leishmaniasis
--Prior/Concurrent Therapy--
No prior treatment for leishmaniasis
--Patient Characteristics--
Hepatic: No clinical or laboratory evidence of hepatic disease
Renal: No clinical or laboratory evidence of renal disease No hyperuricemia or gout
Cardiovascular: No clinical, electrocardiographic, or laboratory evidence of cardiac disease
Other: No allergy or other contraindication to allopurinol or glucantime; No concurrent medication that might interact with study drugs, e.g.: probenecid, warfarin, azathioprine; No skin rash; No malnutrition; No other medical contraindication to protocol therapy; No pregnant or nursing women
12 Years
ALL
No
Sponsors
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Harvard School of Public Health (HSPH)
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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James H. Maguire
Role: STUDY_CHAIR
Harvard School of Public Health (HSPH)
Other Identifiers
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HSPH-11679
Identifier Type: -
Identifier Source: secondary_id
199/11679
Identifier Type: -
Identifier Source: org_study_id