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

Phase 3CompletedNCT02078024

University Hospitals Cleveland Medical Center375 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

375

Conditions

Onchocerciasis

Interventions

IVM plus ALBDRUG

IVMDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital

Hohoe, Ghana

Outcomes

Primary Outcomes

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

Time frame: 36 months

Secondary Outcomes

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.

Time frame: 0, 6, 12, 18, 24 and 36 months

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.

Time frame: 36 months

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.

Time frame: 36 months

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.

Time frame: 0, 6, 12, 18, 24 and 36 months

Data from ClinicalTrials.gov

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