Ivermectin and Human Immunity
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|ClinicalTrials.gov Identifier: NCT03459794|
Recruitment Status : Completed
First Posted : March 9, 2018
Results First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ivermectin||Drug: Ivermectin Other: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effects of Ivermectin on Human Innate Immunity Against Filarial Parasites|
|Actual Study Start Date :||February 12, 2018|
|Actual Primary Completion Date :||April 9, 2018|
|Actual Study Completion Date :||November 30, 2018|
Active Comparator: Ivermectin
Ivermectin will be administered once at 150mcg/kg, orally.
150 mcg/kg ivermectin, by mouth.
Placebo Comparator: Control
An oral placebo will be administered once
An oral placebo will be administered, once
- The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded. [ Time Frame: Pre-treatment, 4 hours and 24 hours post-treatment ]Changes in serum levels of a panel of 41 cytokines will be compared to baseline levels using Luminex methods (HCYTOMAG-60K-PX41 kit from EMD Millipore). No pre-specified threshold was set for biological significance, and the number of cytokines showing a statistically significant (p=<0.05) change from time 0 for each group will be reported. The number of cytokines with significant changes is taken from a comparison of the mean levels in each of the groups, not at the level of individual participants.
- Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels. [ Time Frame: Pre-treatment, 4 hours and 24 hours post-treatment ]Changes in expression levels of approximately 770 genes involved in innate immunity will be measured in peripheral blood mononuclear cells (PBMC) before and after treatment. The number of transcripts with significant changes is taken from a comparison of the mean levels in each of the groups, not at the individual participant level. No pre-determined threshold was set for the biological significance of these changes.
- Complete Blood Counts (CBC) [ Time Frame: Pre-treatment (0hrs), 24 hours ]CBCs will be performed before treatment and 24 hrs later
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): NCT03459794
|United States, Georgia|
|University of Georgia|
|Athens, Georgia, United States, 30602|
|Principal Investigator:||Adrian J Wolstenholme, PhD||University of Georgia|