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

• Status: Withdrawn
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Ivermectin; Milbemycin; Moxidectin

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 ≥ 2800 and ≤ 11300 cells / mL

• Hemoglobin ≥ 11.0 g / dL

• Platelets ≥ 130.000 / mm3

• Creatine serum ≤ 1.25 upper limit of the laboratory

• Total bilirubinemia ≤ 1.25 upper limit of the laboratory

• ALAT ≤ 1.25 upper limit of the laboratory

• Negative urinary strip: absence of leukocyturia, hematuria, and proteinuria (urine strip made a second time in case of positivity, 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