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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
Information provided by (Responsible Party):
Adrian Wolstenholme, University of Georgia

Brief Summary:
We hypothesize that ivermectin, a drug used to treat parasitic worm infections, interacts with the human innate immune system and that this contributes to its anti-parasitic effects. Participants will donate blood before and after being administered the normal human dose of the drug. We will compare the cell types present in the blood and the chemicals known to influence the human immune system before and after the drug is given, as well as measuring any changes in gene expression in white blood cells 4 and 24hrs after the drug is taken.

Condition or disease Intervention/treatment Phase
Ivermectin Drug: Ivermectin Other: Placebo Early Phase 1

Detailed Description:
Subjects will visit the University of Georgia (UGA) Clinical & Translation Research Unit (CTRU) twice on consecutive days and blood will be drawn from them. On the first occasion they will be weighed and will complete the consent process. They will have been randomly assigned to the test (Stromectol) or control (placebo) group, with 8 participants in the test group and 4 participants in the control group. Stromectol will be obtained from a medical supply distributor and a placebo will be obtained through the UGA School of Pharmacy. Drugs will be prescribed by Jonathan Murrow MD. They will be stored in their original packaging at room temperature in a drug locker in the lab at CTRU. Participants will be identified by number and allocated to groups using a block randomization protocol. Randomization and drug dispensation will be done by CTRU. Eighteen ml of blood will drawn in a fasting state and they will be administered 150 mcg/kg Stromectol or the equivalent number of placebo tablets immediately after blood is drawn. Participants will remain at CTRU for four hours after they take the drug, then another 15ml of blood will be drawn. On the second day they will attend CTRU at the same time and the third blood sample will be drawn 24 hrs after administration of the drug. On each occasion the drawn blood will be coded by CTRU staff prior to being collected by a member of the Department of Infectious Diseases and taken to the laboratory (Wildlife Health G0007) for the isolation of leukocyte populations (peripheral monocytes, lymphocytes and polymorphonuclear cells (PMNs)) and for the preparation of serum. Complete blood counts will also be carried out. Sera will be analyzed on the Luminex for cytokine/chemokine content. RNA will be isolated from the cell populations for RNASeq analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Active Comparator: Ivermectin
Ivermectin will be administered once at 150mcg/kg, orally.
Drug: Ivermectin
150 mcg/kg ivermectin, by mouth.

Placebo Comparator: Control
An oral placebo will be administered once
Other: Placebo
An oral placebo will be administered, once

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Complete Blood Counts (CBC) [ Time Frame: Pre-treatment (0hrs), 24 hours ]
    CBCs will be performed before treatment and 24 hrs later

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Weight over 110 pounds and under 185 pounds

Exclusion Criteria:

  • Pregnancy or nursing mothers.
  • Immunosuppressed individuals.
  • Hypersensitivity to ivermectin, cellulose, starch, magnesium stearate, butylated hydroxyanisole, or citric acid powder (inert ingredients of Stromectol).
  • Recent (last 3 years) travel to West or Central Africa, or any other country where onchocerciasis is present
  • Hepatitis/HIV
  • Currently taking warfarin
  • Lactose intolerance (Lactose present in placebo)
  • Currently taking Steroid medications (inhaled, oral or injection)
  • Currently taking Barbiturates, Benzodiazepines such as Xanax or Klonopin, Valproic acid (Lithium), Calcium channel blockers, Statins (cholesterol medication)
  • Liver or renal dysfunction

Information from the National Library of Medicine

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

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United States, Georgia
University of Georgia
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
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Principal Investigator: Adrian J Wolstenholme, PhD University of Georgia
  Study Documents (Full-Text)

Documents provided by Adrian Wolstenholme, University of Georgia:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Adrian Wolstenholme, Professor, University of Georgia
ClinicalTrials.gov Identifier: NCT03459794    
Other Study ID Numbers: STUDY00005069
First Posted: March 9, 2018    Key Record Dates
Results First Posted: July 12, 2019
Last Update Posted: July 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Antiparasitic Agents
Anti-Infective Agents