Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis
Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
Diethylcarbamazine citrate (DEC) treatment of Loa loa infection is complicated by the
development of severe adverse reactions that are correlated with the number of circulating
microfilariae in the blood. The cause of these reactions is unknown, but they are accompanied
by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of
eosinophil activation. This randomized, placebo-controlled, double-blind pilot study
(conducted at the NIH Clinical Center) will assess whether and to what extent the
administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against
IL-5, given 3 to 7 days before administration of the anthelminthic drug DEC (at 3 mg/kg 3
times daily for 21 days), prevents the development of eosinophilia in 10 adult subjects with
Loa loa infection and 0-5000 microfilariae/mL. Secondary outcomes will include the severity
of post-treatment effects, markers of eosinophil activation, and effects of reslizumab on
microfilarial clearance.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)