A 3- to 5-day Clinical Trial of Levamisole in Loiasis Infected Subjects

ConditionLoiasis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorProgramme National de Lutte contre l'Onchocercose, Republic of the Congo

About this trial

The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.

Eligibility criteria

Qualifiers

Consent informed, written, signed and dated

Women or men aged 18 to 65 years inclusive

Carrier of L. loa microfilaremia

Body weight ≥ 40 kg in women and ≥ 45 kg in men; and less than 90 kg

Disqualifiers

Participation in any study other than a purely observational study, within the 4 weeks preceding this study (determined by the theoretical date of the first administration of levamisole or placebo)

Any vaccination within 4 weeks previous to this study

Infection requiring treatment in the 10 days previous to this study, as determined by the anamnesis during the medical interview (e.g. pulmonary infection , digestive or skin infection; with or without antibiotic treatment)

Treatment with clozapine, phenothiazines, sulfasalazine, carbamazepine, synthetic antithyroid drugs, ticlopidine, cimetidine, and gold salts: whether it was long-term treatment, or treatment given as a single dose 10 days before the start of treatment for the clinical trial (precaution with regard to the risk of agranulocytosis of immuno-allergic or toxic origin)

Trial design

Treatments tested in this trial

  • Levamisole 3 days
  • Levamisole 5 days
  • Placebo

Treatment groups

99 Participants
are divided into 3 treatment groups

Sponsors and collaborators