Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Conditions

Onchocerciasis

Keywords

onchocerciasis, river blindness, onchocerca volvulus, moxidectin, ivermectin

Brief summary

This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.

Didier Bakajika, Eric M. Kanza, Nicholas Opoku, Hayford Howard, Germain Mambandu et al. (18 authors)

PLoS neglected tropical diseases2022-04-27145 citations

10.1371/journal.pntd.0010079

Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial.

Opoku NO, Bakajika DK, Kanza EM, Howard H, Mambandu GL, Nyathirombo A, Nigo MM, Kasonia K, Masembe SL, Mumbere M, Kataliko K, Larbelee JP, Kpawor M, Bolay KM, Bolay F, Asare S, Attah SK, Olipoh G, Vaillant M, Halleux CM, Kuesel AC.

2018-01-18104 citations

10.1016/s0140-6736(17)32844-1

A Randomized, Single-Ascending-Dose, Ivermectin-Controlled, Double-Blind Study of Moxidectin in Onchocerca volvulus Infection

Kwablah Awadzi, Nicholas Opoku, Simon K. Attah, Janis K. Lazdins-Helds, Annette C. Kuesel

PLoS neglected tropical diseases2014-06-26237 citations

10.1371/journal.pntd.0002953

Interventions

DRUGMoxidectin

Single dose of moxidectin 2 mg oral tablet x 4

DRUGIvermectin

Single dose of ivermectin 3 mg oral tablet x 2, 3 or 4

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Male and female subjects with Onchocerca volvulus infection

Exclusion criteria

* Pregnant or breast feeding women; coincidental loiasis

Design outcomes

Primary

Measure	Time frame
skin microfilaria density (mf/mg)	12 months

Secondary

Measure	Time frame
skin microfilaria density (mf/mg)	1 month
skin microfilaria reduction from baseline	1 month
proportion of subjects with undetectable levels of skin microfilaria	1 month
percent reduction in microfilaria levels in the anterior chamber of the eye	12 months

Countries

Democratic Republic of the Congo, Ghana, Liberia

Outcome results

None listed