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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004755
First Posted: February 25, 2000
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Harvard School of Public Health
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

OBJECTIVE:

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


Condition Intervention Phase
Leishmaniasis Drug: allopurinol Drug: glucantime Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Allopurinol Versus Glucantime Versus Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 375
Study Start Date: September 1995
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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004755


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard School of Public Health
Investigators
Study Chair: James H. Maguire Harvard School of Public Health
  More Information

ClinicalTrials.gov Identifier: NCT00004755     History of Changes
Other Study ID Numbers: 199/11679
HSPH-11679
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: June 24, 2005
Last Verified: January 1998

Keywords provided by Office of Rare Diseases (ORD):
dermatologic disorders
environmental/toxic disorders
immunologic disorders and infectious disorders
leishmaniasis
rare disease

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Allopurinol
Meglumine antimoniate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents