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

Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004755

Enrollment

375

Registered

2000-02-25

Start date

1995-09-30

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leishmaniasis

Keywords

dermatologic disorders, environmental/toxic disorders, immunologic disorders and infectious disorders, leishmaniasis, rare disease

Brief summary

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

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.

Interventions

DRUGallopurinol

DRUGglucantime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026