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

University Hospitals (UH)

Status and phase: Completed; Phase 3

Conditions: Onchocerciasis

Treatments: Drug: IVM; Drug: IVM plus ALB

Study type: Interventional

Funder types: Other

Identifiers

NCT02078024

CWRU-OCR-1 (Other Identifier)

WU-10-205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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375 participants in 5 patient groups

Annual Ivermectin

Active Comparator group

Description:

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

Treatment:

Drug: IVM

Biannual IVM 200 µg/kg plus ALB 800 mg

Experimental group

Description:

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

Treatment:

Drug: IVM plus ALB

Annual IVM 200 µg/kg plus ALB 800 mg

Experimental group

Description:

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

Treatment:

Drug: IVM plus ALB

Biannual IVM 200 µg/kg

Experimental group

Description:

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

Treatment:

Drug: IVM

IVM 200 µg/kg plus ALB 400 mg

Experimental group

Description:

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

Treatment:

Drug: IVM plus ALB