Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis
|Loiasis||Drug: Reslizumab Drug: Diethylcarbamazine Other: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Drug assignment (reslizumab vs. placebo) and eosinophil countPrimary Purpose: Treatment
|Official Title:||A Randomized, Placebo-controlled, Double-Blind Pilot Study of Single-Dose Humanized Anti-IL5 Antibody (Reslizumab) for the Reduction of Eosinophilia Following Diethylcarbamazine Treatment of Loa Loa Infection|
- Reduction in Peak Eosinophil Count Measure as a Percent of Baseline Count. [ Time Frame: during the first 7 days of DEC treatment ]Peak absolute eosinophil count during the week following DEC treatment as a percent of baseline eosinophil count
- Frequency and Severity of AE's [ Time Frame: 7 days following initiation of DEC treatment ]Adverse events during the first week of DEC treatment
- Markers of Eosinophil Activation Including Levels of Eosinophil Surface Marker Expression and Serum Levels of Eosinophil Granule Proteins [ Time Frame: 12/31/16 ]
- Proportion of Subjects Who Clear Blood Microfilariae [ Time Frame: 3, 7, and 28 days after initiation of treatment with DEC ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||May 2017|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Reslizumab + DEC
Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days
Other Name: CinqairDrug: Diethylcarbamazine
Other Name: Hetrazan, Banocide
Placebo Comparator: Placebo + DEC
Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days
Other Name: Hetrazan, BanocideOther: Placebo
Loa loa is a parasitic worm that infects people in West and Central Africa and is spread by the bite of a deerfly. Adult worms (macrofilariae) live under the skin and cause symptoms such as swellings, itching, and hives. Smaller worms (microfilariae) are found in the bloodstream. Diethylcarbamazine (DEC), the recommended medication for Loa loa infection, can produce very serious side effects, especially in people with high numbers of parasites in the blood. Researchers are investigating new treatments for Loa loa that have fewer or less serious side effects. Researchers believe that a certain kind of blood cells called eosinophils, which increase in the blood after DEC treatment, may be one of the causes of the side effects seen with DEC treatment. Reslizumab is a drug that lowers eosinophils in the blood. Giving reslizumab before DEC treatment might prevent the eosinophils from increasing and reduce some of the side effects from DEC.
- To determine whether reslizumab can prevent or reduce the side effects of treatment with DEC for Loa loa infection.
Screening: Individuals between 18 and 65 years of age who have lived in or traveled to a Loa-endemic region for at least 1 month
Treatment study: Individuals with Loa loa infection and low numbers of parasites in the blood
This study will last 24 months and will involve several visits to the National Institutes of Health Clinical Center. Participants will be screened with a blood test for Loa loa parasites. Those who have a low number of Loa loa parasites in the blood will be asked to return for a full medical evaluation and the start of the treatment phase. Those who do not have Loa loa parasites in the blood, or those who have a high number of Loa loa parasites in the blood, are not eligible for this study treatment but may be eligible for other parasitic disease studies conducted by the National Institutes of Health.
Participants will have an initial visit with a full physical evaluation, and blood and urine tests (including leukapheresis to provide sufficient numbers of blood cells for testing). Within 1 month of the first visit, participants will have a single infusion of either reslizumab or a placebo. The infusion visit is estimated to last approximately 5 hours. Three to 7 days after the infusion, participants will begin a 21-day course of DEC (taken by mouth) to treat the infection. Participants will stay overnight at the Clinical Center during the first 3 days of treatment with DEC to be monitored for side effects, and will continue to take the DEC at home after the inpatient treatment. A study coordinator will call participants each day to ask about any symptoms or side effects. Participants will be seen for an additional eight outpatient follow-up visits (at days 7, 14, and 28, and months 3, 6, 12, 18, and 24) for evaluation of signs and symptoms of infection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111305
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Amy D Klion, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|