Clinical trial NCT04049851: Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 mg Ivermectin-controlled in Loa Loa Microfilaremic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onchocerciasis, Ocular
Loiasis
Lead sponsor: Center for Research on Filariasis and Other Tropical Diseases, Cameroon
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin. This study will be conducted in Cameroon.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of severe adverse events post Moxidectin 2 mg
timeFrame: 1 week
measure: Incidence of adverse events with Moxidectin 2 mg
timeFrame: 1 week
Secondary outcomes:
measure: Proportion of reduction of the microfilarial densities of Loa loa : short term efficacy
timeFrame: Day 7 and Day 15
measure: Proportion of reduction of the microfilarial densities of Loa loa : long term efficacy
timeFrame: Day 80, Day 180, and Year 1
measure: Percentage of individuals without microfilaria post Moxidectin 2 mg
timeFrame: Day 7, Day 90, Day 180, and Year 1
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Centre de recherche sur les filarioses et autres maladies tropicales (CRFilMT)
Study officials:
References: