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

Condition(s) targeted: Onchocerciasis

Intervention: IVM plus ALB (Drug); IVM (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
Christopher L King, MD, PhD, Principal Investigator, Affiliation: Case Western Reserve University
James W Kazura, MD, Principal Investigator, Affiliation: Case Western Reserve University
Nicholas O Opoku, MBChB, MSc, Principal Investigator, Affiliation: Municipal Hospital, Hohoe, Ghana

Overall contact:
Christopher L King, MD, PhD, Phone: 216-368-4817, Email: cxk21@case.edu

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.

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

Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: parasitologic efficacy

Secondary outcome:

additional measures of parasitologic efficacy

compare the percentage living versus dead female worms

compare the number of nodules with intact microfilaria

assess different treatment regimens on Soil Transmitted Helminth infections

determine if IVM plus ALB enhances immunological reactions

determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Men and women 18-60 years residing along the Kpassa in the Nkwanta North District of the Volta Region in Ghana 2. Two or more assessable onchocercal nodules 3. Skin microfilaria density ≥5mf/mg. Exclusion Criteria: 1. 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. 2. Pregnant or breastfeeding women. 3. Low probability of residency in the area (based on subject's assessment) over the next 36 months. 4. 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 5. Weight of <40kg suggesting malnourishment 6. Hemoglobin levels <7 gm/dL 7. aspartate aminotransferase, alanine aminotransferase, creatinine > 1. 5 upper limit of normal. 8. Significant glycosuria or proteinuria (2+ or 3+ protein or glucose). 9. Known or suspected allergy to albendazole or ivermectin or other compounds related to these classes of medication.

Christopher L King, MD, PhD, Phone: 216-368-4817, Email: cxk21@case.edu

Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital, Hohoe, Ghana; Not yet recruiting
Nicholas O Opoku, MBChB, MSc, Principal Investigator

Starting date: June 2014
Last updated: February 28, 2014