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

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ClinicalTrials.gov Identifier: NCT02078024
Recruitment Status : Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: IVM plus ALB Drug: IVM Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.
Study Start Date : June 2014
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Active Comparator: Annual Ivermectin
Ivermectin 200 µg/kg body weight given orally at 0, 12 and 24 months
Drug: IVM
Experimental: Biannual IVM 200 µg/kg plus ALB 800 mg
IVM 200 µg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months.
Drug: IVM plus ALB
Experimental: Annual IVM 200 µg/kg plus ALB 800 mg
IVM 200 µg/kg plus ALB 800 mg given at 0, 12 and 24 months; vitamin pills at given at 6 and 18 months.
Drug: IVM plus ALB
Experimental: Biannual IVM 200 µg/kg
IVM 200 µg/kg given 0, 6, 12, 18, and 24 months.
Drug: IVM
Experimental: IVM 200 µg/kg plus ALB 400 mg
IVM 200 µg/kg plus ALB 400 mg given at 0, 6, 12, 18, and 24 months.
Drug: IVM plus ALB



Primary Outcome Measures :
  1. parasitologic efficacy [ Time Frame: 36 months ]
    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 :
  1. additional measures of parasitologic efficacy [ Time Frame: 0, 6, 12, 18, 24 and 36 months ]
    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.

  2. compare the percentage living versus dead female worms [ Time Frame: 36 months ]
    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.

  3. compare the number of nodules with intact microfilaria [ Time Frame: 36 months ]
    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.

  4. assess different treatment regimens on Soil Transmitted Helminth infections [ Time Frame: 0, 6, 12, 18, 24 and 36 months ]
    To assess different treatment regimens on Soil Transmitted Helminth (STH) infections based on presence and intensity of ova in stools.

  5. determine if IVM plus ALB enhances immunological reactions [ Time Frame: 0, 6, 12, 18, 24 and 36 months ]
    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.

  6. determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae [ Time Frame: 0, 6, 12, 18, 24 and 36 months ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078024


Locations
Ghana
Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital
Hohoe, Ghana
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Christopher L King, MD, PhD Case Western Reserve University
Principal Investigator: James W Kazura, MD Case Western Reserve University
Principal Investigator: Nicholas O Opoku, MBChB, MSc Municipal Hospital, Hohoe, Ghana

Responsible Party: Christopher L. King, MD, PhD, Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02078024     History of Changes
Other Study ID Numbers: WU-10-205
CWRU-OCR-1 ( Other Identifier: CWRU )
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center:
Onchocerciasis

Additional relevant MeSH terms:
Onchocerciasis
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Albendazole
Ivermectin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents