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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: University Hospitals Cleveland Medical Center

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: University Hospitals Cleveland Medical Center

Dates:
Date Received: February 28, 2014
Date Started: June 2014
Date Completion: December 2017
Last Updated: February 28, 2014
Last Verified: February 2014