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Completed

NCT Number: NCT02078024

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

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.

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Key information

Conditions

Onchocerciasis Filariasis Helminthiasis Infections Nematode Infections Parasitic Diseases Secernentea Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Spirurida Infections

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital

Hohoe, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVM plus ALB

Drug

IVM

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2014
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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