Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa Loa Microfilaremic Patients

Study Overview
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Brief Summary
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This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.

Detailed Description
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This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin. This study will be conducted in Cameroon.

Official Title
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Randomized Clinical Trial, Double-blind, Single-dose Drug and Escalating Infection Intensities, Evaluating the Safety and Efficacy of Moxidectin 2 mg, Ivermectin-controlled, in Loa Loa Microfilaremic Patients

Conditions
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Onchocerciasis, Ocular, Loiasis

Intervention / Treatment
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* Drug: Moxidectin 2 MG Oral Tablet
* Drug: Ivermectin 3Mg Tab
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent written, signed (or with a cross) and dated Men aged 18 to 65 included (women not included in the study) Microfilarial density between 1 and 1,000 mf/mL body weight ≥ 45 kg and less than 85 kg Good general condition, as determined by the medical questionnaire and clinical examination Hematological parameters and adequate renal and hepatic functions, such as: Leukocytes ≥ 2,800 and ≤ 11,300 cells/mL Hemoglobin ≥ 10.0 g/dL Platelets ≥100,000/mm3 Serum creatinine ≤ 2.5 upper limit (UL) of the laboratory Total bilirubinemia ≤ 2.5 x UL ALAT ≤ 2.5 x UL Negative urinary strip: absence of leucocyturia, hematuria, and proteinuria (in case of positivity, a second urinary strip test will be made, for confirmation) Exclusion Criteria: Participation in any study other than purely observational, in the 4 weeks preceding this study (determined by the theoretical date of administration of MOX-2 mg or IVM). Person who has taken IVM in the last 6 months Any vaccination in the 4 weeks preceding this study Acute infection requiring a treatment in the 10 days preceding this study, determined by the anamnesis during the medical interview (example: pulmonary infection, ENT, digestive, cutaneous, with implementation of an antibiotic treatment or not) Long-term antiretroviral therapy (protease inhibitor, non-nucleoside reverse transcriptase inhibitor), or treatment with ampicillin or chloramphenicol within 10 days prior to administration of the test drug History or presence of neurological (including epilepsy) or neuropsychiatric disease Excessive consumption of alcohol or other drug abuse within 72 hours prior to the administration of the test treatment determined by the medical history during the medical interview. Any condition, in the opinion of the investigator, which exposes the subject to an undue risk Subjects who donated blood in the 8 weeks prior to study entry, with a standard volume (> 500 mL) Known intolerance to IVM, MOX or any of the excipients (including placebo) During the clinical examination: symptoms, physical signs or biological constants suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric disorders and other abnormalities likely to interfere with the interpretation results of the test. The doctor may then give a favorable or unfavorable opinion for the inclusion of the participant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxidectin<br> | Drug: Moxidectin 2 MG Oral Tablet<br>* One Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo.<br>Drug: Placebo oral tablet<br>* Placebo will be administrated with Moxidectin or ivermectin. Each participant will have 4 tablets in total.<br>|
| Active Comparator: Ivermectin<br> | Drug: Ivermectin 3Mg Tab<br>* 3 ivermectin tablets (or 4 according to the weight) will be blinded and will be administrated with 1 (or 0 according to the weight) tablet of placebo.<br>Drug: Placebo oral tablet<br>* Placebo will be administrated with Moxidectin or ivermectin. Each participant will have 4 tablets in total.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe adverse events post Moxidectin 2 mg | Absence of severe adverse events | 1 week | 
| Incidence of adverse events with Moxidectin 2 mg | Proportion of adverse events during the first week | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of reduction of the microfilarial densities of Loa loa : short term efficacy | Proportion of reduction of the microfilarial densities of Loa loa at Day 7 and Day 15 | Day 7 and Day 15 | 
| Proportion of reduction of the microfilarial densities of Loa loa : long term efficacy | Proportion of reduction of the microfilarial densities of Loa loa at Day 80, Day 180, and Day 365 | Day 80, Day 180, and Year 1 | 
| Percentage of individuals without microfilaria post Moxidectin 2 mg | Percentage of individuals without microfilariae of Loa loa at Day 7, Day 90, Day 180, and Day 365 | Day 7, Day 90, Day 180, and Year 1 |