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

Primary Purpose

Onchocerciasis

Status
Completed
Phase
Phase 3
Locations
Ghana
Study Type
Interventional
Intervention
IVM plus ALB
IVM
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Onchocerciasis focused on measuring Onchocerciasis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Annual Ivermectin

Biannual IVM 200 µg/kg plus ALB 800 mg

Annual IVM 200 µg/kg plus ALB 800 mg

Biannual IVM 200 µg/kg

IVM 200 µg/kg plus ALB 400 mg

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 28, 2014
Last Updated
April 25, 2019
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02078024
Brief Title
Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana
Official Title
Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onchocerciasis
Keywords
Onchocerciasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Annual Ivermectin
Arm Type
Active Comparator
Arm Description
Ivermectin 200 µg/kg body weight given orally at 0, 12 and 24 months
Arm Title
Biannual IVM 200 µg/kg plus ALB 800 mg
Arm Type
Experimental
Arm Description
IVM 200 µg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months.
Arm Title
Annual IVM 200 µg/kg plus ALB 800 mg
Arm Type
Experimental
Arm 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.
Arm Title
Biannual IVM 200 µg/kg
Arm Type
Experimental
Arm Description
IVM 200 µg/kg given 0, 6, 12, 18, and 24 months.
Arm Title
IVM 200 µg/kg plus ALB 400 mg
Arm Type
Experimental
Arm Description
IVM 200 µg/kg plus ALB 400 mg given at 0, 6, 12, 18, and 24 months.
Intervention Type
Drug
Intervention Name(s)
IVM plus ALB
Intervention Type
Drug
Intervention Name(s)
IVM
Primary Outcome Measure Information:
Title
parasitologic efficacy
Description
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 Outcome Measure Information:
Title
additional measures of parasitologic efficacy
Description
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
Title
compare the percentage living versus dead female worms
Description
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
Title
compare the number of nodules with intact microfilaria
Description
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
Title
assess different treatment regimens on Soil Transmitted Helminth infections
Description
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
Title
determine if IVM plus ALB enhances immunological reactions
Description
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.
Time Frame
0, 6, 12, 18, 24 and 36 months
Title
determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae
Description
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.
Time Frame
0, 6, 12, 18, 24 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of the Volta Region in Ghana Two or more assessable onchocercal nodules Skin microfilaria density ≥5mf/mg. Exclusion Criteria: 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. Pregnant or breastfeeding women. Low probability of residency in the area (based on subject's assessment) over the next 36 months. 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 Hemoglobin levels <7 gm/dL aspartate aminotransferase, alanine aminotransferase, creatinine > 1.5 upper limit of normal. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose). Known or suspected allergy to albendazole or ivermectin or other compounds related to these classes of medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher L King, MD, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James W Kazura, MD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicholas O Opoku, MBChB, MSc
Organizational Affiliation
Municipal Hospital, Hohoe, Ghana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital
City
Hohoe
Country
Ghana

12. IPD Sharing Statement

Learn more about this trial

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

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