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

Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004755
• Other study ID #: 199/11679
• Secondary ID: HSPH-11679
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: September 1995

Study information

• Verified date: January 1998
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVE:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

Drug:
• allopurinol

• glucantime

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Harvard School of Public Health