title: A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection.
abstract: BACKGROUND
  Control of onchocerciasis as a public health problem in Africa relies on annual mass ivermectin distribution. New tools are needed to achieve elimination of infection. This study determined in a small number of Onchocerca volvulus infected individuals whether moxidectin, a veterinary anthelminthic, is safe enough to administer it in a future large study to further characterize moxidectin's safety and efficacy. Effects on the parasite were also assessed.
  
  
  RESULTS
  Men and women from a forest area in South-eastern Ghana without ivermectin mass distribution received a single oral dose of 2 mg (N = 44), 4 mg (N = 45) or 8 mg (N = 38) moxidectin or 150 µg/kg ivermectin (N = 45) with 18 months follow up. All ivermectin and 97%-100% of moxidectin treated participants had Mazzotti reactions. Statistically significantly higher percentages of participants treated with 8 mg moxidectin than participants treated with ivermectin experienced pruritus (87% vs. 56%), rash (63% vs. 42%), increased pulse rate (61% vs. 36%) and decreased mean arterial pressure upon 2 minutes standing still after ≥5 minutes supine relative to pre-treatment (61% vs. 27%). These reactions resolved without treatment. In the 8 mg moxidectin and ivermectin arms, the mean±SD number of microfilariae/mg skin were 22.9±21.1 and 21.2±16.4 pre-treatment and 0.0±0.0 and 1.1±4.2 at nadir reached 1 and 3 months after treatment, respectively. At 6 months, values were 0.0±0.0 and 1.6±4.5, at 12 months 0.4±0.9 and 3.4±4.4 and at 18 months 1.8±3.3 and 4.0±4.8, respectively, in the 8 mg moxidectin and ivermectin arm. The reduction from pre-treatment values was significantly higher after 8 mg moxidectin than after ivermectin treatment throughout follow up (p<0.01).
  
  
  CONCLUSIONS
  The 8 mg dose of moxidectin was safe enough to initiate the large study. Provided its results confirm those from this study, availability of moxidectin to control programmes could help them achieve onchocerciasis elimination objectives.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00300768.
authors: Onchocerciasis Chemotherapy Research Centre, Hohoe, Ghana.
authors: Kwablah
authors: K
authors: Awadzi
authors: Onchocerciasis Chemotherapy Research Centre, Hohoe, Ghana.
authors: Nicholas O
authors: NO
authors: Opoku
authors: Onchocerciasis Chemotherapy Research Centre, Hohoe, Ghana; University of Ghana Medical School, Department of Microbiology, Accra, Ghana.
authors: Simon K
authors: SK
authors: Attah
authors: UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland.
authors: Janis
authors: J
authors: Lazdins-Helds
authors: UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland.
authors: Annette C
authors: AC
authors: Kuesel
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D000871:Anthelmintics / Q000008:administration & dosage* / Q000627:therapeutic use; D001794:Blood Pressure; D004311:Double-Blind Method; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D005869:Ghana; D006801:Humans; D007559:Ivermectin / Q000008:administration & dosage* / Q000627:therapeutic use; D018942:Macrolides / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008842:Microfilariae / Q000187:drug effects; D008875:Middle Aged; D017181:Onchocerca volvulus / Q000187:drug effects; D009855:Onchocerciasis / Q000188:drug therapy*; D011537:Pruritus / Q000139:chemically induced; D012867:Skin / Q000187:drug effects / Q000469:parasitology; D055815:Young Adult
chemical_list: D000871:Anthelmintics; D018942:Macrolides; D007559:Ivermectin; C027837:moxidectin