Early Phase 1
N=12
Ivermectin and Human Immunity
Ivermectin
Bottom Line
View on ClinicalTrials.gov: NCT03459794 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded. — 0; 0; 0; 0 Cytokines changed from t=0
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Ivermectin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Georgia
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded. |
0; 0; 0; 0 | — |
| PRIMARY Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels. |
0; 0; 10; 0 | — |
| SECONDARY Complete Blood Counts (CBC) |
3.069; 3.341; 2.940; 3.358; 1.753; 1.864 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03459794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.