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| Descriptive Information Fields | |||||
| Brief Title † | Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil | ||||
| Official Title † | Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil | ||||
| Brief Summary | OBJECTIVE: Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis. |
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| Detailed Description | PROTOCOL OUTLINE: 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Leishmaniasis | ||||
| Intervention † | Drug: allopurinol Drug: glucantime |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 375 | ||||
| Start Date † | September 1995 | ||||
| Completion Date | |||||
| Eligibility Criteria † | PROTOCOL ENTRY 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 |
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00004755 | ||||
| Organization ID | 199/11679 | ||||
| Secondary IDs †† | HSPH-11679 | ||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators †† | Harvard School of Public Health | ||||
| Investigators † |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | January 1998 | ||||
| First Received Date † | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
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