Death to Onchocerciasis and Lymphatic Filariasis: Comparison of Ivermectin alone with Albendazole (ALB) plus Ivermectin (IVM) in their efficacy against Onchocerciasis

INTERVENTION: Treatment regimen 1: The comparator (standard treatment): Ivermectin 200 µg/kg body weight given at 0, 12 and 24 months (annually) plus vitamin pills at 6 and 18 months. (n = 68) Treatment regimen 2: Ivermectin 200 µg/kg body weight plus Albendazole 800 mg (regardless of weight) given at 0, 6, 12, 18, 24 months (bi‐annually). (n = 68) Treatment regimen 3: Ivermectin 200 µg/kg body weight plus Albendazole 800 mg (regardless of weight) given at 0, 12, 24 months (annually) plus vitamin pills at 6 and 18 months. (n = 68) Treatment regimen 4: Ivermectin 200 µg/kg body weight given 0, 6, 12, 18, and 24 months (bi‐annually). (n = 68) Volunteers for this study are recruited based on the inclusion and exclusion criteria and treated directly in their villages. The study drugs will be distributed personally by the research staff. To assess the skin microfilarial load, skin biopsies are taken pre‐treatment, as well as at 6, 18 and 36 months after treatment. Nodulectomies to assess worm vitality and embryogenesis will be performed 36 months after the start of drug administration. Onchocercomata will be removed under local anaesthesia in the hospital. Patients will be kept in hospital for the day of operation or one day longer (depending on the severity of operation) for observation before being discharged. Wound dressing will continue in the villages until all the wounds are healed. CONDITION: Onchocerciasis (Onchocerca volvulus) ; Infections and Infestations ; Onchocerciasis PRIMARY OUTCOME: Percent fertile female adult worms in accessible nodules at 36 months following initiation of therapy SECONDARY OUTCOME: 1. Percent reduction in skin Mf/mg at 0, 6, 18, and 36 months after initiation of therapy. ; 2. Percent reduction in total number of live versus dead female worms in nodules at 36 months following initiation of therapy. ; 3. The number of nodules with intact microfilariae (Mf) at 36 months following initiation of therapy. ; 4. Assessment of the different treatment regimens on Soil Transmitted Helminth (STH) infections based on presence and intensity of ova in stools. INCLUSION CRITERIA: Current inclusion criteria as of 11/11/2013, as stated in the 2nd protocol amendment: 1. Men and women 18‐60 years residing in Ashanti and Central Regions of Ghana 2. =1 accessible nodules 3. Any Mf based on skin snips Previous INCLUSION CRITERIA: 1. Men and women 18‐60 years residing in Central Region of Ghana 2. =1 accessible nodules 3. =5 Mf/mg based on skin snips