Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis

Summary

This study will investigate the safety and effectiveness of combination regimens in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes.

Conditions

• Onchocercal Subcutaneous Nodule
• Onchocerciasis
• Onchocerciasis, Ocular
• Onchocerca Infection
• Tropical Disease

Interventions

DRUG

Ivermectin w/ Albendazole

Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg) plus Albendazole (ALB) (400 mg)

DRUG

Ivermectin + Diethylcarbamazine + Albendazole

Participants will be given a dose of oral Ivermectin (IVM) (150 µg/kg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg)

DRUG

Moxidectin + Albendazole

Participants will be given a dose of oral Moxidectin (Mox) (8 mg) plus Albendazole (ALB) (400 mg)

DRUG

Moxidectin + Diethylcarbamazine + Albendazole

Participants will be given a dose of oral Moxidectin (Mox) (8 mg), Diethylcarbamazine (DEC) (6 mg/kg) and Albendazole (ALB) (400 mg)

Sponsors & Collaborators

• National Public Health Institute of Liberia

  collaborator UNKNOWN

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Peter Fischer, PhD · Washington University School of Medicine

• Patrick Kpanyen, PhD · National Public Health Institute of Liberia

• Gary Weil, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-05

Primary Completion

2026-09-01

Completion

2026-09-01

FDA Drug

Yes

Countries

• Liberia

Study Locations