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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 : Completed
First Posted : March 4, 2014
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE February 28, 2014
First Posted Date  ICMJE March 4, 2014
Last Update Posted Date April 26, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02078024 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana
Official Title  ICMJE Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Onchocerciasis
Intervention  ICMJE
  • Drug: IVM plus ALB
  • Drug: IVM
Study Arms  ICMJE
  • Active Comparator: Annual Ivermectin
    Ivermectin 200 µg/kg body weight given orally at 0, 12 and 24 months
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: IVM plus ALB
  • Experimental: Biannual IVM 200 µg/kg
    IVM 200 µg/kg given 0, 6, 12, 18, and 24 months.
    Intervention: 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.
    Intervention: Drug: IVM plus ALB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 28, 2014)
375
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 25, 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ghana
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02078024
Other Study ID Numbers  ICMJE WU-10-205
CWRU-OCR-1 ( Other Identifier: CWRU )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher L. King, MD, PhD, University Hospitals Cleveland Medical Center
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Hospitals Cleveland Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP