Clinical Trials Logo
  1. Home
  2. Leishmaniasis
  3. NCT00004755

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 Summary

OBJECTIVE:

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

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004755
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 2
Start date September 1995
View Details
See also
  Status Clinical Trial Phase
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT04504435 - Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants Phase 1
Completed NCT00657618 - Use of Sodium Stibogluconate as a Treatment for Leishmaniasis Phase 1/Phase 2
Completed NCT04512742 - A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies N/A
Recruiting NCT00344188 - Diagnosis and Treatment of Leishmania Infections
Active, not recruiting NCT03009422 - Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis. N/A
Recruiting NCT05449717 - Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan
Recruiting NCT06307171 - Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers N/A
Completed NCT01751048 - LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine Phase 1
Terminated NCT06124144 - Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults Phase 1
Completed NCT00662012 - Sodium Stibogluconate Treatment of Leishmaniasis Phase 2
Completed NCT03993093 - Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
Recruiting NCT03784248 - Mediterranean Visceral Leishmaniasis With Leishmania Infantum
Withdrawn NCT02429505 - Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Completed NCT01377974 - Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis Phase 2
Completed NCT02656797 - Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis Phase 2
Completed NCT01484548 - Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers Phase 1
Completed NCT01300975 - Intralesional Antimony for Bolivian Cutaneous Leishmaniasis Phase 2
Completed NCT03294161 - Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis Phase 2
Completed NCT00401557 - Mechanisms Relating to the Distinct in Vitro Susceptibility of Human Macrophages to L. Viannia Infection