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

• Status: Completed
• Trial end date: 2018-06-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Albendazole; Ivermectin

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.