NCT00004755

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 375 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leishmaniasis

Interventions

Type	Name	Description
DRUG	allopurinol
DRUG	glucantime

Timeline

• Start date: 1995-09-01
• First posted: 2000-02-25
• Last updated: 2005-06-24