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

NCT ID: NCT02078024

Last Updated: 2019-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-06-25

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.

Detailed Description

We hypothesize that more effective combinations of dose schedules of existing antifilarial drugs for MDA against onchocerciasis could shorten the number of years needed to interrupt onchocerciasis transmission and eliminate this infectious disease in areas that previously had high disease rates. Improved treatments should also make it feasible to extend MDA into areas that are currently not being helped. These changes have the potential to completely change the game to make global elimination of onchocerciasis a feasible goal.

Participants will be randomized into 5 treatment arms with 75 subjects in each arm for a total of 375 and followed for 36 months after the initial treatment. The primary endpoint will be the percent fertile adult female worms in nodules removed 36 months after the initiation of treatment.

Conditions

Onchocerciasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Annual Ivermectin

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

Group Type: ACTIVE_COMPARATOR

IVM

Intervention Type: DRUG

Biannual IVM 200 µg/kg plus ALB 800 mg

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

Group Type: EXPERIMENTAL

IVM plus ALB

Intervention Type: DRUG

Annual IVM 200 µg/kg plus ALB 800 mg

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

Group Type: EXPERIMENTAL

IVM plus ALB

Intervention Type: DRUG

Biannual IVM 200 µg/kg

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

Group Type: EXPERIMENTAL

IVM

Intervention Type: DRUG

IVM 200 µg/kg plus ALB 400 mg

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

Group Type: EXPERIMENTAL

IVM plus ALB

Intervention Type: DRUG

Interventions

IVM plus ALB

Intervention Type: DRUG

IVM

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of the Volta Region in Ghana

2. Two or more assessable onchocercal nodules

3. Skin microfilaria density ≥5mf/mg.

Exclusion Criteria

1. 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.

2. Pregnant or breastfeeding women.

3. Low probability of residency in the area (based on subject's assessment) over the next 36 months.

4. 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

5. Weight of <40kg suggesting malnourishment

6. Hemoglobin levels <7 gm/dL

7. aspartate aminotransferase, alanine aminotransferase, creatinine > 1.5 upper limit of normal.

8. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose).

9. Known or suspected allergy to albendazole or ivermectin or other compounds related to these classes of medication.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christopher L. King, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher L King, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

James W Kazura, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Nicholas O Opoku, MBChB, MSc

Role: PRINCIPAL_INVESTIGATOR

Municipal Hospital, Hohoe, Ghana

Locations

Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital

Hohoe, , Ghana

Countries

Ghana

Other Identifiers

CWRU-OCR-1

Identifier Type: OTHER

Identifier Source: secondary_id

WU-10-205

Identifier Type: -

Identifier Source: org_study_id