Ivermectin Clinical Trial
Official title:
The Effects of Ivermectin on Human Innate Immunity Against Filarial Parasites
Verified date | April 2019 |
Source | University of Georgia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 30, 2018 |
Est. primary completion date | April 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Georgia | Athens | Georgia |
Lead Sponsor | Collaborator |
---|---|
University of Georgia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded. | 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. | Pre-treatment, 4 hours and 24 hours post-treatment | |
Primary | Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels. | 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. | Pre-treatment, 4 hours and 24 hours post-treatment | |
Secondary | Complete Blood Counts (CBC) | CBCs will be performed before treatment and 24 hrs later | Pre-treatment (0hrs), 24 hours |
Status | Clinical Trial | Phase | |
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