Clinical trial NCT02078024: Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana
Official title: Comparison of Ivermectin Alone With Albendazole (ALB) Plus Ivermectin (IVM) in Their Efficacy Against Onchocerciasis in the Volta Region, Ghana.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onchocerciasis
Keywords: Onchocerciasis
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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 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.

Eligibility 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.

Primary outcomes:
measure: parasitologic efficacy
timeFrame: 36 months
Secondary outcomes:
measure: additional measures of parasitologic efficacy
timeFrame: 0, 6, 12, 18, 24 and 36 months
measure: compare the percentage living versus dead female worms
timeFrame: 36 months
measure: compare the number of nodules with intact microfilaria
timeFrame: 36 months
measure: assess different treatment regimens on Soil Transmitted Helminth infections
timeFrame: 0, 6, 12, 18, 24 and 36 months
measure: determine if IVM plus ALB enhances immunological reactions
timeFrame: 0, 6, 12, 18, 24 and 36 months
measure: determine if the host immune response facilitates killing or sterilizing adult worms and microfilariae
timeFrame: 0, 6, 12, 18, 24 and 36 months
Other outcomes:
Locations:
city: Hohoe
country: Ghana
facility: Onchocerciasis Chemotherapy Research Centre, (OCRC) Municipal Hospital
Study officials:
affiliation: Case Western Reserve University
name: Christopher L King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: James W Kazura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Municipal Hospital, Hohoe, Ghana
name: Nicholas O Opoku, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References: