<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02974049</url>
  </required_header>
  <id_info>
    <org_study_id>08-14-13</org_study_id>
    <nct_id>NCT02974049</nct_id>
  </id_info>
  <brief_title>Lymphatic Filariasis (LF) in Ivory Coast</brief_title>
  <official_title>Alternative Chemotherapies for Lymphatic Filariasis (LF) Treatment and Elimination in Africa [Cote d'Ivoire]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The recommended treatment for elimination of LF in sub-Saharan Africa is annual mass drug&#xD;
      administration (MDA) with single dose Albendazole (ALB) plus Ivermectin (IVM) given for at&#xD;
      least 5-7 years. However, in areas where LF is co-endemic with a related filarial parasite,&#xD;
      Loa loa, co-infection with L. loa represents a serious barrier to LF elimination because IVM&#xD;
      used in LF MDA can result in severe reactions and even death in individuals with high&#xD;
      microfilaria (mf) levels of L. loa. Screening for heavy L. loa infection is problematic. To&#xD;
      overcome this problem, monotherapy with ALB is possible, since this drug has little or no&#xD;
      effect on circulating mf and thus would not cause adverse effects in people with heavy L. loa&#xD;
      infections. Moreover ALB has been shown to have embryostatic or embryocidal effects in female&#xD;
      adult worms resulting in decreased mf levels with time as natural attrition of circulating mf&#xD;
      occurs. Thus this open-label, randomized clinical trial will examine treatment with ALB&#xD;
      monotherapy administered twice per year over a period of 3 years with the primary endpoint&#xD;
      being the proportion of individuals with total clearance of mf at 36 months and Alere antigen&#xD;
      test negativity (a more sensitive circulating antigen test of filarial infection). Two of the&#xD;
      treatment arms will include ALB at two different doses, 400mg or 800mg (fixed dose twice&#xD;
      yearly) as compared to standard treatment of ALB (400 mg) plus IVM (150-200 µg/kg)&#xD;
      administered annually. Observations from an ongoing clinical trial in Papua New Guinea&#xD;
      suggest that a single dose of triple therapy with ALB + IVM + DEC may be highly effective in&#xD;
      sterilizing adult female worms. Therefore to confirm and expand these important preliminary&#xD;
      observations in a different population, a fourth arm will be included in the current clinical&#xD;
      trial in which subjects will receive all three drugs. The clinical trial will be performed in&#xD;
      a region of Cote d'Ivoire where onchocerciasis and loiasis are not endemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes&#xD;
      elephantiasis and genital deformity (especially hydroceles). The infection affects some 120&#xD;
      million people in 81 countries in tropical and subtropical regions with well over 1 billion&#xD;
      people at risk of acquiring the disease. LF is caused by Wuchereria bancrofti and Brugia spp.&#xD;
      (B. malayi and B. timori), nematode parasites that are transmitted by mosquitoes. The World&#xD;
      Health Organization (WHO) developed a plan for LF elimination that is based on using novel&#xD;
      approaches to rapidly map endemic areas and 4 to 6 annual rounds of MDA with antifilarial&#xD;
      medication. A recent summary from WHO reported that more than 4 billion doses of MDA were&#xD;
      distributed between 2000 and 2012. Thus, the Global Program to Eliminate Lymphatic Filariasis&#xD;
      (GPELF) is the largest infectious disease intervention program attempted to date based on MDA&#xD;
      (Ottesen, Hooper et al.&#xD;
&#xD;
      2008). MDA has worked better in some areas than others. There are a number of challenges&#xD;
      faced by GPELF. These include (among others) inability to conduct MDA programs in areas of&#xD;
      Africa where L. loa is coendemic because of the unacceptable risk of Serious Adverse Events&#xD;
      (SAE's) with IVM in persons with heavy L. loa infections (Hoerauf, Pfarr et al. 2011), the&#xD;
      limited macrofilaricidal activity of current MDA regimens (especially ALB + IVM) that&#xD;
      necessitate repeated annual rounds of MDA (Geary and Mackenzie , Hoerauf, Pfarr et al. 2011),&#xD;
      and the difficulty of achieving high compliance rates for MDA over a period of years&#xD;
      (Hoerauf, Pfarr et al. 2011). It is clear that new (or reformulated) drugs and/or dosing&#xD;
      schedules for LF MDA have the potential to greatly improve the number of countries that will&#xD;
      successfully eliminate LF by the WHO target date of 2020. This is especially important for&#xD;
      areas of Central and West Africa where MDA has not been implemented because of the possible&#xD;
      co-infection with L. loa and logistical and financial challenges to delivering annual doses&#xD;
      of IVM + ALB MDA to millions of individuals over multiple years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">September 25, 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total clearance of Microfilariae</measure>
    <time_frame>36 months</time_frame>
    <description>The percentage of participants with total clearance of Microfilariae</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total clearance of MF at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>Percentage of subjects with total clearance of MF at 24 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent MF reduction</measure>
    <time_frame>24 and 36 months</time_frame>
    <description>Percent MF reduction at 24 and 36 months compared to baseline level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in W. bancrofti antigen level</measure>
    <time_frame>12, 24 and 36 months</time_frame>
    <description>Percent reduction in W. bancrofti antigen level measured by Og4C3 assay at 12, 24 and 36 months compared to baseline level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alere Filariasis Test Strip negative</measure>
    <time_frame>12, 24 and 36 months</time_frame>
    <description>Percentage of subjects that become Alere Filariasis Test Strip negative at 12, 24 and 36 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction in viable worm nests</measure>
    <time_frame>12, 24, and 36 months</time_frame>
    <description>Percent reduction in viable worm nests relative to baseline (time 0) based on follow up scrotal ultrasound examination performed at 12, 24 and 36 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diversity of parasites</measure>
    <time_frame>0 and 36 months</time_frame>
    <description>Diversity of parasites before and after treatment using genetic markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>type and level of parasite-specific host immune response</measure>
    <time_frame>0 and 36 months</time_frame>
    <description>Relation of type and level of parasite-specific host immune response with the initial and sustained clearance of parasites</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">189</enrollment>
  <condition>Lymphatic Filariasis</condition>
  <arm_group>
    <arm_group_label>Standard Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Albendazole 400 mg + Ivermectin 200 µg/kg body weight administered annually (at 0, 12 and 24 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALB 400 mg x2 per year</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albendazole 400 mg given at 0, 6, 12, 18, 24 and 30 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALB 800 mg x2 per year</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albendazole 800 mg given at 0, 6, 12, 18, 24 and 30 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALB 400mg + IVM 200mcg/kg + DEC 6mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albendazole 400 mg plus Ivermectin 200 µg/kg body weight plus Diethylcarbamazine 6 mg/kg body weight given one time only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albendazole</intervention_name>
    <description>Subjects in Arms 1, 2, and 4 will receive 400mg of Albendazole&#xD;
Subjects in Arm 3 will receive 800mg of Albendazole</description>
    <arm_group_label>ALB 400 mg x2 per year</arm_group_label>
    <arm_group_label>ALB 400mg + IVM 200mcg/kg + DEC 6mg/kg</arm_group_label>
    <arm_group_label>ALB 800 mg x2 per year</arm_group_label>
    <arm_group_label>Standard Treatment</arm_group_label>
    <other_name>ALB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivermectin</intervention_name>
    <description>Subjects in Arms 1 and 4 will receive 200mg/kg body weight</description>
    <arm_group_label>ALB 400mg + IVM 200mcg/kg + DEC 6mg/kg</arm_group_label>
    <arm_group_label>Standard Treatment</arm_group_label>
    <other_name>IVM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diethylcarbamazine</intervention_name>
    <description>Participants in Arm 4 will receive 6mg/kg of Diethylcarbamazine per body weight</description>
    <arm_group_label>ALB 400mg + IVM 200mcg/kg + DEC 6mg/kg</arm_group_label>
    <other_name>DEC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women and men 18-70 years&#xD;
&#xD;
          -  ≥50 MF/mL based on Nuclepore filtration&#xD;
&#xD;
          -  Willing to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment for LF within last 5 years&#xD;
&#xD;
          -  Pregnancy (perform pregnancy test)&#xD;
&#xD;
          -  Hemoglobin &lt;7 g/dL&#xD;
&#xD;
          -  Permanent disability, serious medical illness that prevents or impedes study&#xD;
             participation and/or comprehension&#xD;
&#xD;
          -  AST/ALT and creatinine &gt;1.5 upper limit of normal&#xD;
&#xD;
          -  Proteinuria or hematuria &gt;3+&#xD;
&#xD;
          -  Skin snip positivity for O. volvulus MF&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher L King, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Western Reserve University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cote d'Ivoire</name>
      <address>
        <city>Abidjan</city>
        <country>Côte D'Ivoire</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Côte D'Ivoire</country>
  </location_countries>
  <reference>
    <citation>Awadzi K, Edwards G, Duke BO, Opoku NO, Attah SK, Addy ET, Ardrey AE, Quartey BT. The co-administration of ivermectin and albendazole--safety, pharmacokinetics and efficacy against Onchocerca volvulus. Ann Trop Med Parasitol. 2003 Mar;97(2):165-78. doi: 10.1179/000349803235001697.</citation>
    <PMID>12803872</PMID>
  </reference>
  <reference>
    <citation>Awadzi K, Edwards G, Opoku NO, Ardrey AE, Favager S, Addy ET, Attah SK, Yamuah LK, Quartey BT. The safety, tolerability and pharmacokinetics of levamisole alone, levamisole plus ivermectin, and levamisole plus albendazole, and their efficacy against Onchocerca volvulus. Ann Trop Med Parasitol. 2004 Sep;98(6):595-614. doi: 10.1179/000349804225021370.</citation>
    <PMID>15324466</PMID>
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  <reference>
    <citation>Bockarie MJ, Tavul L, Ibam I, Kastens W, Hazlett F, Tisch DJ, Alpers MP, Kazura JW. Efficacy of single-dose diethylcarbamazine compared with diethylcarbamazine combined with albendazole against Wuchereria bancrofti infection in Papua New Guinea. Am J Trop Med Hyg. 2007 Jan;76(1):62-6.</citation>
    <PMID>17255231</PMID>
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  <reference>
    <citation>Boussinesq M, Kamgno J, Pion SD, Gardon J. What are the mechanisms associated with post-ivermectin serious adverse events? Trends Parasitol. 2006 Jun;22(6):244-6. doi: 10.1016/j.pt.2006.04.006. Epub 2006 Apr 24. No abstract available.</citation>
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    <citation>Chu, B. K., P. J. Hooper, M. H. Bradley, D. A. McFarland and E. A. Ottesen</citation>
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  <reference>
    <citation>Geary TG. Ivermectin 20 years on: maturation of a wonder drug. Trends Parasitol. 2005 Nov;21(11):530-2. doi: 10.1016/j.pt.2005.08.014. Epub 2005 Aug 26.</citation>
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  <reference>
    <citation>Ottesen EA. Lymphatic filariasis: Treatment, control and elimination. Adv Parasitol. 2006;61:395-441. doi: 10.1016/S0065-308X(05)61010-X.</citation>
    <PMID>16735170</PMID>
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  <reference>
    <citation>Geary TG, Mackenzie CD. Progress and challenges in the discovery of macrofilaricidal drugs. Expert Rev Anti Infect Ther. 2011 Aug;9(8):681-95. doi: 10.1586/eri.11.76.</citation>
    <PMID>21819332</PMID>
  </reference>
  <reference>
    <citation>Hoerauf A, Pfarr K, Mand S, Debrah AY, Specht S. Filariasis in Africa--treatment challenges and prospects. Clin Microbiol Infect. 2011 Jul;17(7):977-85. doi: 10.1111/j.1469-0691.2011.03586.x.</citation>
    <PMID>21722251</PMID>
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  <reference>
    <citation>Hooper PJ, Bradley MH, Biswas G, Ottesen EA. The Global Programme to Eliminate Lymphatic Filariasis: health impact during its first 8 years (2000-2007). Ann Trop Med Parasitol. 2009 Oct;103 Suppl 1:S17-21. doi: 10.1179/000349809X12502035776513.</citation>
    <PMID>19843394</PMID>
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    <citation>Horton J. Albendazole: a broad spectrum anthelminthic for treatment of individuals and populations. Curr Opin Infect Dis. 2002 Dec;15(6):599-608. doi: 10.1097/00001432-200212000-00008.</citation>
    <PMID>12821837</PMID>
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    <citation>Horton J. The development of albendazole for lymphatic filariasis. Ann Trop Med Parasitol. 2009 Oct;103 Suppl 1:S33-40. doi: 10.1179/000349809X12502035776595.</citation>
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    <citation>Hotez PJ, Savioli L, Fenwick A. Neglected tropical diseases of the Middle East and North Africa: review of their prevalence, distribution, and opportunities for control. PLoS Negl Trop Dis. 2012;6(2):e1475. doi: 10.1371/journal.pntd.0001475. Epub 2012 Feb 28.</citation>
    <PMID>22389729</PMID>
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    <citation>Kitzman D, Wei SY, Fleckenstein L. Liquid chromatographic assay of ivermectin in human plasma for application to clinical pharmacokinetic studies. J Pharm Biomed Anal. 2006 Mar 3;40(4):1013-20. doi: 10.1016/j.jpba.2005.08.026. Epub 2005 Oct 19.</citation>
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    <citation>Mand S, Debrah A, Batsa L, Adjei O, Hoerauf A. Reliable and frequent detection of adult Wuchereria bancrofti in Ghanaian women by ultrasonography. Trop Med Int Health. 2004 Oct;9(10):1111-4. doi: 10.1111/j.1365-3156.2004.01304.x.</citation>
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    <citation>McGarry HF, Plant LD, Taylor MJ. Diethylcarbamazine activity against Brugia malayi microfilariae is dependent on inducible nitric-oxide synthase and the cyclooxygenase pathway. Filaria J. 2005 Jun 2;4:4. doi: 10.1186/1475-2883-4-4.</citation>
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    <citation>Ottesen EA, Hooper PJ, Bradley M, Biswas G. The global programme to eliminate lymphatic filariasis: health impact after 8 years. PLoS Negl Trop Dis. 2008 Oct 8;2(10):e317. doi: 10.1371/journal.pntd.0000317.</citation>
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    <citation>Weil GJ, Curtis KC, Fakoli L, Fischer K, Gankpala L, Lammie PJ, Majewski AC, Pelletreau S, Won KY, Bolay FK, Fischer PU. Laboratory and field evaluation of a new rapid test for detecting Wuchereria bancrofti antigen in human blood. Am J Trop Med Hyg. 2013 Jul;89(1):11-15. doi: 10.4269/ajtmh.13-0089. Epub 2013 May 20.</citation>
    <PMID>23690552</PMID>
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    <citation>Zoure HG, Wanji S, Noma M, Amazigo UV, Diggle PJ, Tekle AH, Remme JH. The geographic distribution of Loa loa in Africa: results of large-scale implementation of the Rapid Assessment Procedure for Loiasis (RAPLOA). PLoS Negl Trop Dis. 2011 Jun;5(6):e1210. doi: 10.1371/journal.pntd.0001210. Epub 2011 Jun 28.</citation>
    <PMID>21738809</PMID>
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  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Christopher L. King, MD, PhD</investigator_full_name>
    <investigator_title>Professor of International Health, Medicine and Pathology</investigator_title>
  </responsible_party>
  <keyword>Ivermectin</keyword>
  <keyword>Albendazole</keyword>
  <keyword>Diethylcarbamazine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Filariasis</mesh_term>
    <mesh_term>Elephantiasis, Filarial</mesh_term>
    <mesh_term>Elephantiasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivermectin</mesh_term>
    <mesh_term>Albendazole</mesh_term>
    <mesh_term>Diethylcarbamazine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Not personal identifying data but infection levels will be shared.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02974049
org study id: 08-14-13
nct id: NCT02974049
lead sponsor: 
collaborator: 
has dmc: Yes
The recommended treatment for elimination of LF in sub-Saharan Africa is annual mass drug
      administration (MDA) with single dose Albendazole (ALB) plus Ivermectin (IVM) given for at
      least 5-7 years. However, in areas where LF is co-endemic with a related filarial parasite,
      Loa loa, co-infection with L. loa represents a serious barrier to LF elimination because IVM
      used in LF MDA can result in severe reactions and even death in individuals with high
      microfilaria (mf) levels of L. loa. Screening for heavy L. loa infection is problematic. To
      overcome this problem, monotherapy with ALB is possible, since this drug has little or no
      effect on circulating mf and thus would not cause adverse effects in people with heavy L. loa
      infections. Moreover ALB has been shown to have embryostatic or embryocidal effects in female
      adult worms resulting in decreased mf levels with time as natural attrition of circulating mf
      occurs. Thus this open-label, randomized clinical trial will examine treatment with ALB
      monotherapy administered twice per year over a period of 3 years with the primary endpoint
      being the proportion of individuals with total clearance of mf at 36 months and Alere antigen
      test negativity (a more sensitive circulating antigen test of filarial infection). Two of the
      treatment arms will include ALB at two different doses, 400mg or 800mg (fixed dose twice
      yearly) as compared to standard treatment of ALB (400 mg) plus IVM (150-200 µg/kg)
      administered annually. Observations from an ongoing clinical trial in Papua New Guinea
      suggest that a single dose of triple therapy with ALB + IVM + DEC may be highly effective in
      sterilizing adult female worms. Therefore to confirm and expand these important preliminary
      observations in a different population, a fourth arm will be included in the current clinical
      trial in which subjects will receive all three drugs. The clinical trial will be performed in
      a region of Cote d'Ivoire where onchocerciasis and loiasis are not endemic.
Lymphatic filariasis (LF) is a deforming and disabling infectious disease that causes
      elephantiasis and genital deformity (especially hydroceles). The infection affects some 120
      million people in 81 countries in tropical and subtropical regions with well over 1 billion
      people at risk of acquiring the disease. LF is caused by Wuchereria bancrofti and Brugia spp.
      (B. malayi and B. timori), nematode parasites that are transmitted by mosquitoes. The World
      Health Organization (WHO) developed a plan for LF elimination that is based on using novel
      approaches to rapidly map endemic areas and 4 to 6 annual rounds of MDA with antifilarial
      medication. A recent summary from WHO reported that more than 4 billion doses of MDA were
      distributed between 2000 and 2012. Thus, the Global Program to Eliminate Lymphatic Filariasis
      (GPELF) is the largest infectious disease intervention program attempted to date based on MDA
      (Ottesen, Hooper et al.

      2008). MDA has worked better in some areas than others. There are a number of challenges
      faced by GPELF. These include (among others) inability to conduct MDA programs in areas of
      Africa where L. loa is coendemic because of the unacceptable risk of Serious Adverse Events
      (SAE's) with IVM in persons with heavy L. loa infections (Hoerauf, Pfarr et al. 2011), the
      limited macrofilaricidal activity of current MDA regimens (especially ALB + IVM) that
      necessitate repeated annual rounds of MDA (Geary and Mackenzie , Hoerauf, Pfarr et al. 2011),
      and the difficulty of achieving high compliance rates for MDA over a period of years
      (Hoerauf, Pfarr et al. 2011). It is clear that new (or reformulated) drugs and/or dosing
      schedules for LF MDA have the potential to greatly improve the number of countries that will
      successfully eliminate LF by the WHO target date of 2020. This is especially important for
      areas of Central and West Africa where MDA has not been implemented because of the possible
      co-infection with L. loa and logistical and financial challenges to delivering annual doses
      of IVM + ALB MDA to millions of individuals over multiple years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Total clearance of Microfilariae
time frame: 36 months
description: The percentage of participants with total clearance of Microfilariae
measure: Total clearance of MF at 24 months
time frame: 24 months
description: Percentage of subjects with total clearance of MF at 24 months
measure: Percent MF reduction
time frame: 24 and 36 months
description: Percent MF reduction at 24 and 36 months compared to baseline level
measure: Reduction in W. bancrofti antigen level
time frame: 12, 24 and 36 months
description: Percent reduction in W. bancrofti antigen level measured by Og4C3 assay at 12, 24 and 36 months compared to baseline level
measure: Alere Filariasis Test Strip negative
time frame: 12, 24 and 36 months
description: Percentage of subjects that become Alere Filariasis Test Strip negative at 12, 24 and 36 months
measure: reduction in viable worm nests
time frame: 12, 24, and 36 months
description: Percent reduction in viable worm nests relative to baseline (time 0) based on follow up scrotal ultrasound examination performed at 12, 24 and 36 months
measure: Diversity of parasites
time frame: 0 and 36 months
description: Diversity of parasites before and after treatment using genetic markers
measure: type and level of parasite-specific host immune response
time frame: 0 and 36 months
description: Relation of type and level of parasite-specific host immune response with the initial and sustained clearance of parasites
arm group label: Standard Treatment
arm group type: Active Comparator
description: Albendazole 400 mg + Ivermectin 200 µg/kg body weight administered annually (at 0, 12 and 24 months)
arm group label: ALB 400 mg x2 per year
arm group type: Experimental
description: Albendazole 400 mg given at 0, 6, 12, 18, 24 and 30 months
arm group label: ALB 800 mg x2 per year
arm group type: Experimental
description: Albendazole 800 mg given at 0, 6, 12, 18, 24 and 30 months
arm group label: ALB 400mg + IVM 200mcg/kg + DEC 6mg/kg
arm group type: Experimental
description: Albendazole 400 mg plus Ivermectin 200 µg/kg body weight plus Diethylcarbamazine 6 mg/kg body weight given one time only
intervention type: Drug
intervention name: Albendazole
description: Subjects in Arms 1, 2, and 4 will receive 400mg of Albendazole
Subjects in Arm 3 will receive 800mg of Albendazole
arm group label: ALB 400 mg x2 per year
arm group label: ALB 400mg + IVM 200mcg/kg + DEC 6mg/kg
arm group label: ALB 800 mg x2 per year
arm group label: Standard Treatment
other name: ALB
intervention type: Drug
intervention name: Ivermectin
description: Subjects in Arms 1 and 4 will receive 200mg/kg body weight
arm group label: ALB 400mg + IVM 200mcg/kg + DEC 6mg/kg
arm group label: Standard Treatment
other name: IVM
intervention type: Drug
intervention name: Diethylcarbamazine
description: Participants in Arm 4 will receive 6mg/kg of Diethylcarbamazine per body weight
arm group label: ALB 400mg + IVM 200mcg/kg + DEC 6mg/kg
other name: DEC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Christopher L King, MD PhD
role: Principal Investigator
affiliation: Case Western Reserve University
facility: 
country: Côte D'Ivoire
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PMID: 21738809
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Christopher L. King, MD, PhD
investigator title: Professor of International Health, Medicine and Pathology
mesh term: Filariasis
mesh term: Elephantiasis, Filarial
mesh term: Elephantiasis
mesh term: Ivermectin
mesh term: Albendazole
mesh term: Diethylcarbamazine
sharing ipd: Yes
ipd description: Not personal identifying data but infection levels will be shared.