MedTrace Logo

SCH708980 With and Without AmBisome for Visceral Leishmaniasis

NCT01437020 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2013-08-28

No results posted yet for this study

Summary

Background:

\- Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also affect the blood and immune system. One possible treatment for VL involves an experimental drug called SCH708980, which may help to prevent the immune system from becoming suppressed and worsening the VL. Researchers want to give the drug along with AmBisome(Registered Trademark), which kills the parasites, to see if it is a safe and effective treatment.

Objectives:

\- To study the safety and effectiveness of SCH708980, alone and combined with AmBisome(Registered Trademark), as a treatment for visceral leishmaniasis.

Eligibility:

* Individuals 18 to 60 years of who have been diagnosed with visceral leishmaniasis in the past 4 to 5 days, are HIV-negative, and are willing to stay in the hospital for 30 days.
* All participants will come from and be treated at the Kala-Azar Medical Research Center in Muzaffarpur, India.

Design:

* This is a two-part study. Participants will be assigned to only one part of the study.
* Participants will be screened with a medical history and physical exam; blood, urine, and stool samples, spleen or bone marrow samples; spleen measurements; a chest xray; and a heart function test.
* Part 1 participants will be separated into two groups: a larger group will have a selected dose of the study drug followed by AmBisome 7 days later, and a smaller group will have a placebo treatment followed by AmBisome.
* Part 2 participants will have either the study drug or a placebo plus AmBisome, based on the test results from the Part 1 participants.
* All participants will be monitored in the hospital for 30 days, and will have the following tests:
* Regular blood samples
* Urine and stool samples (day 14)
* Spleen measurements (days 8, 14, 21, and 30)
* Spleen or bone marrow sample (day 30 only). Participants who still have VL symptoms will give another sample on day 45.
* At 6 months after the start of treatment, participants will have a follow-up visit with spleen measurements, blood and stool samples, and possible spleen or bone marrow samples

Conditions

  • Leishmaniasis
  • Effects of Immunotherapy

Interventions

DRUG

SCH708980 Anti-IL-10 monoclonal

Participants in Part 1 of the study will receive varying doses (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 10.0 mg/kg) of a single IV infusion of SCH708980. Participants in Part 2 of the study will receive a single IV infusion of SCH708980 on Day 1.

DRUG

AmBisome

Participants in Part 1 of the study will receive a single IV infusion of AmBisome (10 mg/kg) 7 days after they receive SCH708980. Participants in Part 2 of the study will receive varying doses (3.75 mg/kg, 5 mg/kg, or 10 mg/kg) of a single IV infusion of AmBisome on Day 8.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Shyam Sundar, MD · Institute of Medical Sciences, Banaras Hindu Universtiy, Varanasi, India

  • David Sacks, PhD · Laboratory of Parasitic Diseases, NIAID, NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437020 on ClinicalTrials.gov