Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leishmaniasis
Intervention: allopurinol (Drug); glucantime (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
James H. Maguire, Study Chair, Affiliation: Harvard School of Public Health
Summary
OBJECTIVE:
Compare the efficacy and side effects of allopurinol versus glucantime versus
allopurinol/glucantime in patients in Brazil with cutaneous leishmaniasis.
Clinical Details
Official title: Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: September 1995
Last updated: June 23, 2005
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