Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana

NCT02078024 | Completed Phase 3 DMC

• 2 other identifiers: WU-10-205CWRU-OCR-1
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

We will examine whether a combination of Ivermectim (IVM) plus Albendazole (ALB) compared to IVM alone given annually, which is the current standard for mass drug administration (MDA), is more effective in sterilizing adult worms. We will also address whether IVM plus ALB given twice per year is superior to IVM given once per year or twice per year.

Conditions

Onchocerciasis

Keywords

Onchocerciasis

Outcome Measures

Primary Outcomes (1)

• parasitologic efficacy

  To compare the parasitologic efficacy, as measured by percent fertile adult female worms in nodules at 36 months after administration of annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvolus

  36 months

Secondary Outcomes (6)

• additional measures of parasitologic efficacy

  0, 6, 12, 18, 24 and 36 months

• compare the percentage living versus dead female worms

  36 months

• compare the number of nodules with intact microfilaria

  36 months

• assess different treatment regimens on Soil Transmitted Helminth infections

  0, 6, 12, 18, 24 and 36 months

• determine if IVM plus ALB enhances immunological reactions

  0, 6, 12, 18, 24 and 36 months

Study Arms (5)

Annual Ivermectin

ACTIVE COMPARATOR

Ivermectin 200 µg/kg body weight given orally at 0, 12 and 24 months

Drug: IVM

Biannual IVM 200 µg/kg plus ALB 800 mg

EXPERIMENTAL

IVM 200 µg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months.

Drug: IVM plus ALB

Annual IVM 200 µg/kg plus ALB 800 mg

EXPERIMENTAL

IVM 200 µg/kg plus ALB 800 mg given at 0, 12 and 24 months; vitamin pills at given at 6 and 18 months.

Drug: IVM plus ALB

Biannual IVM 200 µg/kg

EXPERIMENTAL

IVM 200 µg/kg given 0, 6, 12, 18, and 24 months.

Drug: IVM

IVM 200 µg/kg plus ALB 400 mg

EXPERIMENTAL

IVM 200 µg/kg plus ALB 400 mg given at 0, 6, 12, 18, and 24 months.

Drug: IVM plus ALB

Interventions

IVM plus ALB DRUG

Annual IVM 200 µg/kg plus ALB 800 mg; Biannual IVM 200 µg/kg plus ALB 800 mg; IVM 200 µg/kg plus ALB 400 mg

IVM DRUG

Annual Ivermectin; Biannual IVM 200 µg/kg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of the Volta Region in Ghana
• Two or more assessable onchocercal nodules
• Skin microfilaria density ≥5mf/mg.

You may not qualify if:

• Prior treatment with the antifilarial and/or anti-nematodal drugs diethylcarbamazine, suramin, ivermectin, albendazole, levamisole or \>1week of treatment with doxycycline, within 12 months before planned test article administration.
• Pregnant or breastfeeding women.
• Low probability of residency in the area (based on subject's assessment) over the next 36 months.
• Permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study participation and/or comprehension
• Weight of \<40kg suggesting malnourishment
• Hemoglobin levels \<7 gm/dL
• aspartate aminotransferase, alanine aminotransferase, creatinine \> 1.5 upper limit of normal.
• Significant glycosuria or proteinuria (2+ or 3+ protein or glucose).
• Known or suspected allergy to albendazole or ivermectin or other compounds related to these classes of medication.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital

Hohoe, Ghana

Location

MeSH Terms

Conditions

Onchocerciasis

Interventions

Intravital Microscopy; Albumins

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Christopher L King, MD, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• James W Kazura, MD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Nicholas O Opoku, MBChB, MSc

  Municipal Hospital, Hohoe, Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 4, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 25, 2018
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

GH (1)