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

Onchocerciasis Clinical Trial

Official title:

Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02078024
• Other study ID #: WU-10-205
• Secondary ID: CWRU-OCR-1
• Status: Completed
• Phase: Phase 3
• Start date: June 2014
• Est. completion date: June 25, 2018

Study information

• Verified date: April 2019
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: June 25, 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Onchocerciasis

Intervention

Drug:
• IVM plus ALB

• IVM

Locations

Country	Name	City	State
Ghana	Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital	Hohoe

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	additional measures of parasitologic efficacy	To compare additional measures of parasitologic efficacy of annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvulus as measured by skin microfilaria levels at additional time points.	0, 6, 12, 18, 24 and 36 months
Secondary	compare the percentage living versus dead female worms	To compare the percentage living versus dead female worms in nodules at 36 months following initiation of therapy of annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvulus.	36 months
Secondary	compare the number of nodules with intact microfilaria	To compare the number of nodules with intact microfilaria (Mf) at 36 months after administration annual doses of oral ivermectin alone versus ivermectin plus albendazole given annually or biannually in the treatment of subjects infected with Onchocerca volvulus.	36 months
Secondary	assess different treatment regimens on Soil Transmitted Helminth infections	To assess different treatment regimens on Soil Transmitted Helminth (STH) infections based on presence and intensity of ova in stools.	0, 6, 12, 18, 24 and 36 months
Secondary	determine if IVM plus ALB enhances immunological reactions	To determine if IVM plus ALB enhances immunological reactions to adult worms antigens, or release of circulating parasite antigens as potential biomarkers of drug efficacy.	0, 6, 12, 18, 24 and 36 months
Secondary	determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae	To determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae. This can be accomplished by examining immune biomarkers prior to and following treatment using stored whole blood, and serum/plasma samples.	0, 6, 12, 18, 24 and 36 months