Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil

National Institute of Allergy and Infectious Diseases (NIAID)375 enrolled

Overview

OBJECTIVE: Compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

375

Conditions

Leishmaniasis

Interventions

allopurinolDRUG

glucantimeDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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