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

Locations

2
Supervisor SibitiKomono, Republic of the Congo
General Supervisor SibitiMokassi, Republic of the Congo

Sponsors and collaborators

Programme National de Lutte contre l'Onchocercose, Republic of the Congo

Lead sponsor

Institut de Recherche pour le Developpement

Collaborator