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| ID | Type | Description | Link |
|---|---|---|---|
| CWRU-OCR-1 | Other Identifier | CWRU |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Annual Ivermectin | Active Comparator | Ivermectin 200 µg/kg body weight given orally at 0, 12 and 24 months |
|
| Biannual IVM 200 µg/kg plus ALB 800 mg | Experimental | IVM 200 µg/kg plus ALB 800 mg (regardless of weight) given at 0, 6, 12, 18, and 24 months. |
|
| Annual IVM 200 µg/kg plus ALB 800 mg | Experimental | IVM 200 µg/kg plus ALB 800 mg given at 0, 12 and 24 months; vitamin pills at given at 6 and 18 months. |
|
| Biannual IVM 200 µg/kg | Experimental | IVM 200 µg/kg given 0, 6, 12, 18, and 24 months. |
|
| IVM 200 µg/kg plus ALB 400 mg | Experimental | IVM 200 µg/kg plus ALB 400 mg given at 0, 6, 12, 18, and 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVM plus ALB | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| parasitologic efficacy | 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 | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| additional measures of parasitologic efficacy | 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. | 0, 6, 12, 18, 24 and 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital | Hohoe | Ghana |
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| ID | Term |
|---|---|
| D009855 | Onchocerciasis |
| ID | Term |
|---|---|
| D005368 | Filariasis |
| D017205 | Spirurida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
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| ID | Term |
|---|---|
| D000069416 | Intravital Microscopy |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| IVM |
| Drug |
|
| compare the percentage living versus dead female worms | 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. | 36 months |
| compare the number of nodules with intact microfilaria | 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. | 36 months |
| assess different treatment regimens on Soil Transmitted Helminth infections | To assess different treatment regimens on Soil Transmitted Helminth (STH) infections based on presence and intensity of ova in stools. | 0, 6, 12, 18, 24 and 36 months |
| determine if IVM plus ALB enhances immunological reactions | 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. | 0, 6, 12, 18, 24 and 36 months |
| determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae | 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. | 0, 6, 12, 18, 24 and 36 months |
| D006373 |
| Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008919 |
| Investigative Techniques |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |