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Trial record 46 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

IVM Alone vs ALB + IVM Against Onchocerciasis

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ClinicalTrials.gov Identifier: NCT03238131
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Christopher L. King, MD, PhD, Case Western Reserve University

Brief Summary:
Onchocerciasis is a vector-borne nematode parasitic disease that causes severe disability. Onchocerciasis affects approximately 33 million people, mostly in 30 countries in sub-Saharan Africa (with small foci in Latin America and Yemen) 1This disease causes blindness and severe skin disease and it is spread by black flies. O. volvulus adult worms live in subcutaneous nodules. O. volvulus adult worms are larger and less sensitive to available drug treatments than those of the species that cause Lymphatic Filariasis (LF). They also have a longer lifespan (approximately 14 years rather than the estimated 7 years for LF parasites). Several programs and developments have greatly improved the Onchocerciasis. situation since the 1970's when the Onchocerciasis Control Programme (OCP) in West Africa (green countries in the map) was initiated. OCP relied exclusively on vector (black fly) control in its early years. However, following the appearance of Ivermectin (Mectizan) on the scene in the late 1980's, OCP transitioned to become a drug distribution program with annual IVM MDA in 11 countries. OCP ended in 2002. This was replaced by the African Program for Onchocerciasis Control (APOC) which coordinates community directed distribution of IVM MDA in 28 African countries (including the former OCP countries). OCP and APOC have done a good job of reducing parasite infection intensities and Onchocerciasis disease rates in many endemic countries. Unfortunately, there is no real end in sight for the APOC approach (apart from a funding endpoint in 2015); while it may be possible to eliminate Onchocerciasis. In selected areas by MDA with IVM (alone, or combined with vector control), disease control programs in most African countries will require active maintenance for many years to come. While IVR has good activity against the parasite larvae that cause disease in the skin and eye (microfilariae or Mf), it does not kill O. volvulus adult worms, and they resume production of Mf that can lead to transmission of new Onchocerciasis. Cases by black flies after a few months. APOC activities are focused on areas with high infection rates (where disease risks are highest). However, extensive areas in Africa where fewer than 20% of adult men have Onchocerciasis nodules detectable by palpation are not receiving interventions for Onchocerciasis at this time. These areas are not disease free. (Onchocerciasis dermatitis can be severe in hypoendemic areas), and they also may serve as a source for reintroduction of the parasite into previously controlled areas after interventions stop.

Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: Ivermectin Drug: Albendazole Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis
Study Start Date : April 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Active Comparator: IVM annually (standard treatment)
The comparator (standard treatment) IVM 200 µg/kg body weight given at 0, 12 and 24 months plus vitamin pills at 6 and 18 months.
Drug: Ivermectin
Participants are either given Ivermectin alone or Ivermectin in combination with Albendazole

Experimental: IVM plus ALB twice annually
IVM 200 µg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, 24 months
Drug: Ivermectin
Participants are either given Ivermectin alone or Ivermectin in combination with Albendazole

Drug: Albendazole
Albendazole will be given to participants in Arm 2 and 3 in combination with Ivermectin at varying time points.

Active Comparator: IVM plus ALB once annually
IVM 200 µg/kg plus ALB 800 mg given at 0, 12, 24 months plus vitamin pills at 6 and 18 months.
Drug: Ivermectin
Participants are either given Ivermectin alone or Ivermectin in combination with Albendazole

Drug: Albendazole
Albendazole will be given to participants in Arm 2 and 3 in combination with Ivermectin at varying time points.

Active Comparator: IVM twice annually
IVM 200 µg/kg given 0, 6, 12, 18, and 24 months
Drug: Ivermectin
Participants are either given Ivermectin alone or Ivermectin in combination with Albendazole




Primary Outcome Measures :
  1. The percent fertile female O.volvulus worms in nodules [ Time Frame: 36 months ]
    Total number of live versus dead female worms in nodules


Secondary Outcome Measures :
  1. Percent reduction in skin Mf/mg [ Time Frame: 0 months ]
    Percent of live female worms in nodules

  2. Percent reduction in skin Mf/mg [ Time Frame: 6 months ]
    Total number of live versus dead female worms in nodules compared to time point zero

  3. Percent reduction in skin Mf/mg [ Time Frame: 18 months ]
    Total number of live versus dead female worms in nodules compared to time point zero

  4. Percent reduction in skin Mf/mg [ Time Frame: 36 months ]
    Total number of live versus dead female worms in nodules compared to time point zero

  5. Number of nodules with intact Mf [ Time Frame: 36 months ]
    number of nodules with intact Mf at 36 months following initial therapy

  6. Soil Transmitted Helminth (STH) infections [ Time Frame: 36 months ]
    Assessment of the different treatment regimens on STH infections based on presence of intensity of ova in stools.



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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:

  • Men and women 18-60 years residing in Ashanti and Central Region of Ghana
  • ≥1 accessible nodules
  • any Mf/mg based on skin snips
  • Willingness to give informed consent to participation in the study

Exclusion Criteria:

  • Last IVM treatment < 7 months
  • Pregnant (do pregnancy test) + breastfeeding
  • 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
  • AST/ALT, γ-GT > 1.5 upper limit of normal
  • Significant glycosuria or proteinuria (2+ or 3+ protein or glucose)
  • Any one or more of the previous criteria is sufficient to exclude study participation
  • Not willing or able to give informed consent to participate in the study.

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): NCT03238131


Locations
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Ghana
Committee on Human Research Publications and Ethics
Kumasi, Ashanti, Ghana
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Washington University School of Medicine

Publications:

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Responsible Party: Christopher L. King, MD, PhD, Professor of International Health, Medicine and Pathology, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03238131     History of Changes
Other Study ID Numbers: 11-11-36
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Filariasis
Anti-Infective Agents
Onchocerciasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Albendazole
Antiparasitic Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents