IVM Alone vs ALB + IVM Against Onchocerciasis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03238131
• Date of registration: 25/07/2017
• Prospective Registration: No
• Primary sponsor: University Hospitals Cleveland Medical Center
• Public title: IVM Alone vs ALB + IVM Against Onchocerciasis
• Scientific title: Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis
• Date of first enrolment: April 2012
• Target sample size: 272
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03238131
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Ghana

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women 18-60 years residing in Ashanti and Central Region of Ghana

- =1 accessible nodules

- any Mf/mg based on skin snips

- Willingness to give informed consent to participation in the study

Exclusion Criteria:

- Last IVM treatment < 7 months

- Pregnant (do pregnancy test) + breastfeeding

- 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

- AST/ALT, ?-GT > 1.5 upper limit of normal

- Significant glycosuria or proteinuria (2+ or 3+ protein or glucose)

- Any one or more of the previous criteria is sufficient to exclude study participation

- Not willing or able to give informed consent to participate in the study.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Onchocerciasis

Intervention(s)

Drug: Albendazole

Drug: Ivermectin

Primary Outcome(s)

The percent fertile female O.volvulus worms in nodules [Time Frame: 36 months]

Secondary Outcome(s)

Percent reduction in skin Mf/mg [Time Frame: 0 months]

Soil Transmitted Helminth (STH) infections [Time Frame: 36 months]

Percent reduction in skin Mf/mg [Time Frame: 36 months]

Number of nodules with intact Mf [Time Frame: 36 months]

Percent reduction in skin Mf/mg [Time Frame: 18 months]

Percent reduction in skin Mf/mg [Time Frame: 6 months]

Secondary ID(s)

11-11-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Washington University School of Medicine