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| Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Harvard School of Public Health |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004755 |
Purpose
OBJECTIVE:
Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.
| Condition | Intervention | Phase |
|---|---|---|
|
Leishmaniasis |
Drug: allopurinol Drug: glucantime |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil |
| Estimated Enrollment: | 375 |
| Study Start Date: | September 1995 |
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
| Study ID Numbers: | 199/11679, HSPH-11679 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004755 History of Changes |
| Health Authority: | United States: Federal Government |
|
dermatologic disorders environmental/toxic disorders immunologic disorders and infectious disorders leishmaniasis rare disease |
|
Antimetabolites Leishmaniasis Protozoan Infections Allopurinol Skin Diseases, Infectious Antioxidants |
Skin Diseases Meglumine antimoniate Rare Diseases Parasitic Diseases Leishmaniasis, Cutaneous Antirheumatic Agents |
|
Antimetabolites Anti-Infective Agents Allopurinol Antiprotozoal Agents Antioxidants Molecular Mechanisms of Pharmacological Action Skin Diseases, Parasitic Physiological Effects of Drugs Mastigophora Infections Leishmaniasis, Cutaneous Gout Suppressants Antiparasitic Agents Therapeutic Uses |
Free Radical Scavengers Parasitic Diseases Leishmaniasis Protozoan Infections Skin Diseases Meglumine antimoniate Enzyme Inhibitors Protective Agents Pharmacologic Actions Skin Diseases, Infectious Sarcomastigophora Infections Antirheumatic Agents |
