Request History

• Restore to current request
• applications/index/page:84/sort:protocol_no/direction:asc
• applications/index/page:82/sort:study_title/direction:desc
• applications/index/page:71/sort:study_title/direction:desc
• applications/index/page:79/sort:study_title/direction:desc

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1763949062
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • page65
  • sortstudy_title
  • directiondesc
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page65
    • current5
    • count529
    • prevPage(true)
    • nextPage(true)
    • pageCount106
    • order(array)
      • Application.study_titledesc
    • limit5
    • options(array)
      • page65
      • order(array)
        • Application.study_titledesc
      • sortstudy_title
      • directiondesc
    • paramTypenamed

Post data

• Application(empty)

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

• keys(array)
  • 0controller
  • 1action
• options(empty)
• defaults(array)
  • plugin(null)
• template/:controller/:action/*

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id226
      • user_id97
      • trial_status_id6
      • abstract_of_study<p style=\"margin-left:4.5pt;\">\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">A randomized clinical controlled field trial in 360 randomly allocated primary school children aged 6 to 9 years with parental or guardian’s consent and attending selected schools in Kilifi District. The objective of the study is to determine the pre - and post - intervention impact of supplementation with iron and vitamin B12 singly and in combination on nutritional status, morbidity, haematological indices, serum ferritin, and serum vitamin B12 levels. Controls will be randomly allocated children receiving no intervention. Data collection will be by questionnaire on socio-demography, morbidity, 24 hour dietary recall, physical examination, anthropometric measurements, mid upper arm circumference, skin caliper thickness, class performance, total blood count; erythrocyte sedimentation rate, serum ferritin and vitamin B12 levels, This will be a repeat study design of above parameters at baseline, 3 months and six months. Collected information will be coded and cleaned. Exploratory Data Analysis will give descriptive statistics with frequencies, means, modes and median, quartile and inter-quartile ranges. Bivariate assessment will be done and categorical data subjected to Chi Square analysis and continuous data will be subjected to student t-test. Data with three or more variables will be subjected to ANOVA. Analysis will compare pre- and post- intervention variables between the study groups.</span></span></p>\n
      • study_title<p>\n <strong><span style=\"font-size: 16px;\">The Impact of Supplementation with Iron and Vitamin B12 Singly and In Combination on Nutritional Status and Morbidity Among Primary School Children.</span></strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/10/03
      • version_noFInal
      • date_of_protocol02-02-2012
      • study_drugOrofer and vitamin B12
      • disease_conditionMorbidity and Nutritional status
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameIron III polymaltose complex and cyanocobalamin
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresspm_nyakundi@yahoo.co.uk
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Priscilla M. Nyakundi
      • declaration_date116-10-2013
      • declaration_principal_investigatorDr. Priscilla M. Nyakundi
      • declaration_date216-10-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1<span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">. Primary school children<br />\n 2. Male and female<br />\n 3. Aged six (6) to nine (9) years. </span></span></p>\n<p>\n <span style=\"font-family: \'times new roman\', times, serif;\">4. Having an informed consent  signed by the parent or legal guardian</span></p>\n<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">5. Parent or legal guardian willing for child to stay on the study for the full study duration of six months.</span></span></p>\n
      • principal_exclusion_criteria<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">1. A child outside the six to nine years age group.<br />\n 2. Unavailability of a signed informed consent by the parent or legal guardian<br />\n 3. A very sick child with a known chronic illness like HIV, kidney or hear disease.<br />\n 4. Unwillingness to stay the full duration of the study.<br />\n 5. A child in another study.<br />\n 6. A child on other micronutrient supplements.<br />\n 7. Severe case of malnutrition with complications</span></span><br />\n  </p>\n
      • primary_end_points<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">1. Morbidity incidence<br />\n 2. Change in nutritional status.<br />\n 3. Change in class performance</span></span></p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Staff</strong></p>\n<p>\n Dr. P. M. Nyakundi : MBCHB, M. MED., M. Sc., CTM. P.I.. - Coordinator</p>\n<p>\n Dr.Yeri Kombe : PhD. - JKUAT Supervisor.</p>\n<p>\n Prof. A. Makoha : PhD - JKUAT Supervisor.</p>\n<p>\n Rose Kiage : KCHN.</p>\n<p>\n Benson Oisebe : Pharmaceutical Technician.</p>\n<p>\n Stephen Onteri B. Sc.-  Biochemical analyst.</p>\n<p>\n Cleophas Paul Wayodi: Lboratory Technologist - Phlebotomist.</p>\n<p>\n Bernard Rotich Lboratory Technologist - Phlebotomist.</p>\n<p>\n Health teacher : 4 - monitor study cases in school for any adverse events.</p>\n<p>\n Community Health Workers : 18 - Monitor study cases at House Hold level for adverse events and 24 hour dietary recall.</p>\n<p>\n <strong>Site facilities</strong></p>\n<p>\n Available electricity supply in Ganze, Tsangalawen and Sokoke primary schools. Project staff will process the blood at Pwani Maternity Hospital in Kilifi.</p>\n<p>\n Four Cool boxes for transporting samples from site to laboratry.</p>\n<p>\n Two freezers</p>\n<p>\n Liquid nitrogen tanks will be used to freeze and store plasma.</p>\n<p>\n CPHR Nutrition laboratory will conduct the ferritn studies.</p>\n<p>\n University o Nairobi will assay the vitaminB12</p>\n<p>\n <strong>Emergency</strong></p>\n<p>\n Dr. P. M. Nyakundi</p>\n<p>\n Teresia Mamburi CCO : Ganze Health Centre.</p>\n<p>\n Leornard Baya : CHN, CHM : Sokoke Dispensary.</p>\n<p>\n Dr. Neema : Kilifi District Hospital.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Not applicable.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n All approvals are from Kenyan authorities for the one trial site in Kilifi COunty.</p>\n<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size: 12px;\">1. Centre For Public Health Research.  Approved: 23.3.2011<br />\n 2. KEMRI Scientific Steering Committee.Approved: 7th June 2011.<br />\n 3. KEMRI Ethics Review Committeee. Approved: February 2, 2012.<br />\n 4. Ministry of Public Health and Sanitation.Approved 27th February 2012.<br />\n 5. Ministry of Education.Approved 8th March 2012.<br />\n District Education Office, Director, Quality Assurance and Standards. Approved: 8th March 2012.<br />\n 6. Kilifi County, Ganze District. Approved: 9th October 2012.</span></span></p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationSix months.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorIron compared to vitamin
      • design_controlled_other_medicinalYes
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKilifi County, Ganze District.
      • single_site_physical_addressDistrict Education Office, P. O. Box 6 GANZE.
      • single_site_contact_personMr. Jackson U. Daido
      • single_site_telephone04-17522556;
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siteThe study has one site. Total cases 360.
      • total_participants_worldwide360
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyA six to nine year old child needs parental or guardian\'s informed consent in order to participate in the study.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namePriscilla
      • investigator1_middle_nameMonyangi
      • investigator1_family_nameDr. Nyakundi
      • investigator1_qualificationMBCHB,. M. MED. (paediatrics). M. Sc. (Immunology). C. T. M.
      • investigator1_professional_addressKenya Medical Research Institute, Centre for Clinical Research, P. O. Box 20778 - 00202, Nairobi
      • investigator1_telephone(254) 020 2722541; (254) 0722 523 609
      • investigator1_emailpm_nyakundi@yahoo.co.uk
      • organisations_transferred_No
      • number_participantsThree hundred and sixty (360) maximum
      • notification<p>\n No.</p>\n
      • approval_date02-02-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-10-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2014-04-02 21:54:47
      • created2013-10-11 22:02:24
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id157
        • application_id226
        • given_namePriscilla
        • middle_nameMonyangi
        • family_nameDr. Nyakundi
        • qualificationMBCHB, M. MED. (Paediatrics) M. SC (Immunology), C. T. M., PhD in progress
        • professional_addressKenya Medical Research Institute, Centre for CLinical Research
        • telephone(254) 020 2722541; (254) 0722 523 609
        • emailpm_nyakundi@yahoo.co.uk
        • created2013-10-11 22:10:35
        • modified2013-10-27 03:11:01
    • SiteDetail(array)
      • 0(array)
        • id197
        • application_id226
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-10-11 22:10:35
        • modified2013-10-27 03:11:01
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id123
        • application_id226
        • sponsorP. I., Dr. Priscilla Monyangi Nyakundi
        • sponsor_type(null)
        • contact_personDr. Priscilla Monyangi Nyakundi
        • addressKenya Medical Research Institute, Centre for Clinical Research, P. O. Box 20778 - 00202, Nairobi
        • telephone_number(254) 020 2722541
        • fax_number020 2720030
        • cell_number(+254) 0722 523 609
        • email_addresspm_nyakundi@yahoo.co.uk
        • created2013-10-11 22:10:35
        • modified2013-10-27 03:11:01
  • 1(array)
    • Application(array)
      • id609
      • user_id351
      • trial_status_id4
      • abstract_of_study<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n This is a Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability and efficacy of rilpivirine (RPV, previously known as TMC278) 25 mg once daily (q.d.) or an adjusted dose of RPV (q.d.) in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n (N[t]RTIs) (zidovudine [AZT], abacavir [ABC], or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC], whichever is approved and marketed or considered local standard of care) in antiretroviral (ARV) treatment-naïve adolescents and children aged ≥ 6 to <18 years.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The trial will consist of a screening period of maximum 8 weeks, an initial treatment period of 48 weeks, and a post Week 48 treatment extension period of 4 years. Subjects who withdraw from the trial on or before the Week 48 visit or subjects with ongoing (serious) adverse events ([S]AEs) at the last on-treatment visit in the extension, will be seen for a follow-up visit 4 weeks later. Recruitment and analyses of the initial 48-week treatment period will be structured into 2 age cohorts: Cohort 1, adolescents ≥12 to <18 years of age; Cohort 2, children ≥6 to <12 years of age.</p>\n
      • study_title<p>\n <strong style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">A Phase II, open label, single arm trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of rilpivirine (TMC278) in antiretroviral-naïve HIV-1 infected adolescents and children aged ≥6 to <18 years</strong></p>\n
      • laymans_summary<p>\n HIV and AIDs still remain an important public health problem worldwide. It is estimated that 35 million people are living with HIV worldwide, out of which 3 million are children. In Kenya, 1.5 million people are living with HIV of which 200,000 are children less than 15 years of age. Human immunodeficiency virus type 1 (HIV-1) infected patients are routinely treated with a combination of 3 drugs (highly active ARV therapy, HAART), Despite the use of HAART, viral suppression in children is still suboptimal. In Kenya, viral suppression in children is at about 50% as compared to 75% in adults. This study aims to find how effective a new drug called Rilpivirine is in fighting the HIV virus in children equal to or more than 6 years to children less than 12 years. The study will also determine the appropriate dose and safety of Rilpivirine in this age group</p>\n
      • short_titlePAINT Study
      • protocol_noECCT/17/06/02
      • version_noClinical Trial Protocol Amendment 7.0
      • date_of_protocol18-12-2015
      • study_drugrilpivirine hydrochloride
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameEDURANT®
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressnkisengese@yahoo.co.uk
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantNicodemus Ivuti Kisengese
      • declaration_date121-06-2017
      • declaration_principal_investigatorDr Isaac Tsikhutsu
      • declaration_date221-06-2017
      • placebo_presentNo
      • study_objectives<h1>\n 1.0OBJECTIVES</h1>\n<h2>\n 1.1Part 1 Objectives</h2>\n<ul>\n <li>\n To evaluate the steady-state pharmacokinetics of RPV 25 mg q.d. or adjusted dose of RPV (q.d.) in participants aged ≥6 to <12 years;</li>\n <li>\n To evaluate short-term safety, tolerability and antiviral activity/efficacy of RPV in these age groups.</li>\n</ul>\n<h2>\n 1.2Part 2 Objectives</h2>\n<ul>\n <li>\n To evaluate safety, tolerability and efficacy of RPV over a 48-week treatment period;</li>\n <li>\n To evaluate immunologic changes (as measured by CD4+ cell parameters) over 48 weeks of treatment with RPV;</li>\n <li>\n To assess the evolution of viral genotype and phenotype over 48 weeks of treatment with RPV;</li>\n <li>\n To evaluate pharmacokinetics and Pharmacokinetic-pharmacodynamic relationships for safety and efficacy of RPV;</li>\n <li>\n To evaluate treatment adherence as measured by the Study Adherence Questionnaire for Children and Teenagers;</li>\n <li>\n To evaluate the safety, tolerability and efficacy of RPV for up to 240 weeks of treatment.</li>\n</ul>\n
      • principal_inclusion_criteria<div>\n  </div>\n<div>\n <table class=\"table table-condensed\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; width: 902px; margin-bottom: 20px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221);\">\n <div>\n Subjects who meet all of the following criteria are eligible for this trial:</div>\n <ol style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px;\">\n <li style=\"line-height: 20px;\">\n Cohort 1: Boys or girls, aged ≥12 to <18 years. Cohort 2: Boys or girls, aged ≥6 to <12 years.</li>\n <li style=\"line-height: 20px;\">\n Cohort 1: Subject’s weight is ≥32 kg.Cohort 2: Subject’s weight is ≥17 kg.</li>\n <li style=\"line-height: 20px;\">\n Subject with documented chronic HIV-1 infection.</li>\n <li style=\"line-height: 20px;\">\n Subject willing and able to give consent. In case the subject’s age is below the cut-off age for consent (according to local regulations), their parent/caregiver should be able and willing to give consent, and the subject will be informed about the trial and asked to give positive assent.</li>\n <li style=\"line-height: 20px;\">\n Subject can comply with the protocol requirements.</li>\n <li style=\"line-height: 20px;\">\n Subject has, prior to screening, never been treated with a therapeutic HIV vaccine or an HIV drug with the exception of a single dose of NVP (Cohort 1) or up to 6 weeks of AZT use (Cohort 2) to prevent MTCT.</li>\n <li style=\"line-height: 20px;\">\n HIV-1 plasma viral load at screening ≥500 HIV-1 RNA copies/mL but ≤100,000 HIV-1 RNA copies/mL (assayed by RNA polymerase chain reaction [PCR] standard specimen procedure).  <u>Note</u>: For Cohort 1 Part 1a, subjects with a screening viral load ≥5,000 HIV-1 RNA copies/mL were allowed.<u>  Note:</u> To reassess eligibility, retesting of a screening value that leads to exclusion will be allowed only once during the screening period using an unscheduled visit.</li>\n <li style=\"line-height: 20px;\">\n In the judgment of the investigator, it is appropriate to initiate ART based on the subject’s medical condition and taking into account guidelines for the treatment of HIV-1 infection in children of this age group. <u>Note:</u> Most current treatment guidelines recommend considering initiation of ART when CD4+ cell counts are <350 cells/mm³. However, clinical situations may warrant initiating ART with CD4+ cell counts >350 cells/mm³. An example of such situations would include rapidly declining CD4+ cell counts over time.</li>\n <li style=\"line-height: 20px;\">\n Results from the screening HIV-1 genotype demonstrate sensitivity to the selected N(t)RTIs.</li>\n <li style=\"line-height: 20px;\">\n Subject is able to swallow the RPV tablet as a whole (since the tablet cannot be chewed, broken, or crushed), except when the appropriate RPV dose for the subjects is determined to be <25 mg (only applicable for subjects enrolled after it has been decided that a lower RPV dose is appropriate for subjects up to a certain e.g., age or body weight). In this case an age-appropriate formulation other than the tablet formulation will be provided.</li>\n <li style=\"line-height: 20px;\">\n The subject agrees (or their parents/caregivers agree, in case the subject's age is below the cut-off age for consent according to local regulations, in which case the subject is informed and asked to give positive assent) not to start ART before the baseline visit.</li>\n <li style=\"line-height: 20px;\">\n General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.</li>\n </ol>\n </td>\n </tr>\n </tbody>\n </table>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Any previous use of ARVs, with the exception of a single dose of NVP (Cohort 1) or up to 6 weeks of AZT use (Cohort 2) to prevent MTCT.</div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Note: Cohort 1: Subjects who were infected by MTCT are allowed to enter, provided the mother was ARV treatment-naïve at the time of delivery with the exception of</div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n NVP for no more than 3 days.</div>\n
      • primary_end_points<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 14px;\"><strong>Efficacy</strong></span></div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u>Plasma viral load</u></div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Throughout the analysis, plasma viral load will be log10 transformed. Plasma viral load reported as <50 HIV-1 RNA copies/mL will be scored as 49 HIV-1 RNA copies/mL, if not otherwise mentioned.</div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u>Parameters for Part 1:</u></div>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n The change in plasma viral load from baseline at Week 2 (Cohort 1 Part 1a, Cohort 2)/Week 4 (Cohort 1 Part 1b).</li>\n</ul>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u>Parameters for Part 2:</u></div>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Proportion of subjects with a viral load <50 and <400 HIV-1 RNA copies/mL at all time points, and time to achieve these;</li>\n <li style=\"line-height: 20px;\">\n Proportion of subjects with a decrease from baseline in plasma viral load of 1.0 log10 at Week 12</li>\n <li style=\"line-height: 20px;\">\n Change from baseline in log10 viral load;</li>\n <li style=\"line-height: 20px;\">\n Time to loss of response.</li>\n</ul>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 14px;\"><strong>Immunology</strong></span></div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u>Immunology parameter:</u></div>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n The change from baseline in CD4+ cell count (absolute and %).</li>\n</ul>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The analysis will be based on observed values and on imputed values using NC = F, i.e., subjects who prematurely discontinued the trial and will have their CD4+ cell count following discontinuation imputed with the baseline value (resulting in a change of 0), and will have LOCF for intermediate missing values.</div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Raw data and changes versus baseline will be descriptively and graphically presented.</div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u>Resistance Determinations</u></div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The results of the viral pheno- and genotypes will be evaluated by the Protocol Virologist. Relevant changes in the viral phenotype and genotype will be tabulated and described, particularly for subjects with virologic failure. These changes in viral phenotype and genotype will not be regarded as AEs.</div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Furthermore, phenotypic resistance data, including the fold change in EC50 values, of RPV and other ARVs will be described.</div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </div>\n<div font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <div>\n  </div>\n <div>\n <strong>Safety</strong></div>\n <div>\n  </div>\n <div>\n <u>Adverse Events/HIV-Related Events</u></div>\n <div>\n Type (system organ class, preferred term) and incidence of all AEs and HIV-related events, between the signing of ICF and last trial-related activity, will be tabulated per trial period (i.e., screening, the treatment period and follow-up). Separate tabulations will be made by severity, drug relationship, and outcome of the AEs. Separate tabulations and listings will be made for those subjects who have discontinued the trial for an AE/HIV-related event, or who experienced a grade 3r 4 AE, or an SAE.</div>\n</div>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-size: 10pt; font-family: Tahoma, sans-serif;\">The Kericho CRC, established in 1998, is located 260 km Northwest of Nairobi in Kericho town on the grounds of the Ministry of Health, Kericho County Referral Hospital. USAMRU-K has been in Kenya for 45 years and has partnered with KEMRI since 1980. KEMRI is a Government of Kenya para-state corporation responsible for health research. The CRC has three integrated main components: HIV care, HIV and microbiology research. Since 2003 the CRS has been conducting diverse studies including randomized, double-blind, placebo controlled and IND/FDA-regulated studies The CRS has 181 local and one U.S. staff with appropriate trainings to support the clinical trials and HIV care and treatment programs. The staff includes; 10 doctors, 3 pharmacists, 12 clinical officers, 25 nurses, 36 laboratory technologists and six 6 accountants among others. The CRS has a Community Advisory Board, strong community engagement programs, efficient participant recruitment, retention and follow-up processes. The CRS protocols are reviewed by the KEMRI and WRAIR IRBs. The CRS’s, secure physical infrastructure includes: 1) 13,400 square feet (sq. ft.) clinical research building for reception, waiting areas, clinical procedures, consultation, sample collection, pharmacy, quality assurance, IT servers, data entry, participants’ chart archives, and sample storage, 2) 26,115 sq. ft. Laboratory space, 3) two liquid nitrogen plants, 4) four back-up generators 5) 13,500 sq. ft. administration and 6) 6,000 sq. ft. store. Both the CRC pharmacy and laboratory are approved by the National Institute of Allergy and Infectious Diseases/Division of AIDS (NIAID/DAIDS) to participate in DAIDS sponsored vaccine (Site # 1502) and therapeutics (Site #12501) and International Maternal, Pediatric, and Adolescent AIDS Clinical Trials (IMPAACT) Group (Site # 5121) studies, the only research site with such approval in Kenya. The lab is also College of American Pathologists (CAP) accredited and consists of three main sections: HIV, Microbiology and Mycobacterium Tuberculosis (TB). The KEMRI/WRP CRC research activities are integrated with a large comprehensive public health HIV care, treatment and prevention program managed by KEMRI/WRP and supported by PEPFAR which covers a population of about 2.7 million people in the SRV which is also the CRS research catchment area. Elements supported by the program includes: antiretroviral therapy (ART), non-ART, TB/HIV co-infections, PMTCT, HIV Testing and Counseling (HTC), primary HIV infection prevention in both low and high-risk populations, Orphans and Vulnerable Children (OVC), and Voluntary Medical Male Circumcision (VMMC). Kenya had an estimated population in 2012 of 43 million people, 22% of whom are urban and with an annual population growth rate of 2.4%. The adult (15-64 years) HIV/AIDS prevalence rate is 5.6% (6.9% in women, and 4.4% in men). HIV prevalence among children aged 18 months to 14 years was 0.9%. In 2013, the country notified a total of 89,760 TB cases (all forms of tuberculosis) of whom 37% were also HIV infected and the South Rift Valley had a total of 4,302 TB cases in 2013.<o:p></o:p></span></p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The trial is conducted in five countries across Africa, USA and Asia. This is to collect more data across different geographic regions.</span></p>\n
      • other_details_regulatory_notapproved<p>\n Not Applicable</p>\n
      • other_details_regulatory_approved<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Ministry of Health Kenya Pharmacy and Poisons Board, approval letter Ref. No. PPB/ECCT/16/10/02/2017(009)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Uganda National Council for Science and Technology  has approved 2 sites</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Thailand Ministry of Health has approved one site </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n South Africa Medicines Control Council has approved 3 sites </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n United States of America has approved 2 sites</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n India drug regulatory authority has approved one site</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration5 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites2
      • multi_country_listUSA Thailand Kenya Uganda South Africa
      • data_monitoring_committeeYes
      • total_enrolment_per_site6
      • total_participants_worldwide56
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren aged between 12 and less than 18 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameIsaac
      • investigator1_middle_name
      • investigator1_family_nameTsikhutsu
      • investigator1_qualificationMBchB,MMED, FPCCM
      • investigator1_professional_addressKenya Medical Research Institute/Walter Reed Project, Clinical Research Centre, Kericho, Kenya
      • investigator1_telephone+254 729 110124/+2545221064/30686
      • investigator1_emailisaac.tsikhutsu@usamru-k.org
      • organisations_transferred_No
      • number_participants6-12
      • notification<p>\n The protocol received PPB approval for the Prof Walter Jaoko site, KAVI Institute of Clinical Research, University of Nairobi.</p>\n
      • approval_date10-10-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-06-23 21:27:43
      • created2017-06-12 10:11:35
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id387
        • application_id609
        • given_nameIsaac
        • middle_name
        • family_nameTsikhutsu
        • qualificationMBchB,MMED, FPCCM
        • professional_addressKenya Medical Research Institute/Walter Reed Project, Clinical Research Centre, Kericho, Kenya
        • telephone+254 729 110124/+2545221064/30686
        • emailisaac.tsikhutsu@usamru-k.org
        • created2017-06-12 10:29:38
        • modified2020-06-23 21:27:43
    • SiteDetail(array)
      • 0(array)
        • id491
        • application_id609
        • county_id35
        • site_nameKenya Medical Research Institute/Walter Reed Project, HIV Program
        • physical_addressHospital Road, Kericho, Kenya
        • contact_detailsP.O Box 1357 - 20200, Hospital Road, Kericho, Kenya Tel: +254 52 30686/+254 52 30388 Mobile: +254 729110124 Fax: +254 52 30662/+254 52 30546
        • contact_personDr. Isaac Tsikhutsu, MBChB, MMED, FPCCM
        • site_capacity(null)
        • misc(null)
        • created2017-06-12 10:29:38
        • modified2020-06-23 21:27:43
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id495
        • application_id609
        • county_id47
        • site_nameKAVI Institute of Clinical Research
        • physical_addressDepartment of Medical Microbiology,College of Health Sciences University of Nairobi
        • contact_detailsP.O Box 19676 Nairobi-00202, Kenya Tel: +254 727 555 254
        • contact_personProfessor Walter Jaoko
        • site_capacity(null)
        • misc(null)
        • created2017-06-20 12:36:11
        • modified2020-06-23 21:27:43
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id311
        • application_id609
        • sponsorJanssen Research and Development
        • sponsor_typeResearch Institution
        • contact_personLinda Carole Roach
        • addressBuilding 6, Country Club Estates 21 Woodlands Drive Woodmead, 2191, South Africa.
        • telephone_number+27 11 518 7173
        • fax_number+27 11 518 7102/3
        • cell_number+27 71 622 2242
        • email_addresslroach@its.jnj.com
        • created2017-06-12 10:29:38
        • modified2020-06-23 21:27:43
  • 2(array)
    • Application(array)
      • id706
      • user_id81
      • trial_status_id4
      • abstract_of_study<p>\n  </p>\n<p style=\"margin: 0px; text-align: justify;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">We will explore the </font></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">potential benefits of negative pressure ventilation (NPV) in combination with prophylactic anticonvulsants to ameliorate the adverse outcomes secondary to cerebral malaria (CM). </font></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">The major pathophysiology in cerebral malaria is an increase in the overall </font></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">cerebral volume and vasogenic raised intracranial pressure (distinct from raised intracranial pressure associated with meningitis) as a result of parasite sequestration, venous congestion, or ischaemia due to seizures. Prophylactic anticonvulsant medication could avert ‘spikes’ of intracranial pressure during repeated seizure events; yet with current treatments (diazepam, and phenobarbitone as second-line) these come at a risk of hypoventilation and respiratory arrest, as demonstrated in the phenobarbitone trial. In high-income countries, management incorporates mechanical ventilation; but this is not available in the majority of resource-limited hospitals in Africa. Alternatives to intubation and mechanical ventilation include non-invasive ventilation (</font></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">NIV), which has been proven to work in a wide range of patients including those with central hypoventilation syndrome. </font></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">We propose to </font></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">prevent the major pathological complications of CM and major mode of death, respiratory arrest, by preventing or reducing intracranial hypertension by targeting the cerebral vasodilation (through the use of a prophylactic anticonvulsant, </font></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">levetiracetam</font></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">) in combination with NIV as a promising strategy to </font></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">avert deaths and neurological sequelae from CM. </font></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">Biphasic Cuirass Ventilation (BCV) is a NIV system that is portable, requires no intubation, does not require specialist medical personnel, and can be used </font></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">across a wide weight and age range (</font></span><a href=\"http://www.hayekmedical.com/about-bcv/\"><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#0563c1\" face=\"Calibri\" size=\"3\">http://www.hayekmedical.com/about-bcv/</font></span></a><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">). BCV </font></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">could be transferred to Africa if studies showed that it could be safely and effectively implemented. </font></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">We will conduct a phase I trial to </font><span style=\"background: white; margin: 0px;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">generate </font></span></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\" face=\"Calibri\" size=\"3\">feasibility, safety and preliminary data on seizure control of BCV as non-invasive ventilatory support in cerebral malaria with and without prophylactic anticonvulsant (levetiracetam).</font></span></p>\n<p>\n  </p>\n
      • study_title<p>\n <span style=\"margin: 0px; line-height: 115%; font-family: "Calibri",sans-serif; font-size: 11pt;\"><u><b><font color=\"#000000\">NO</font></b></u></span><span style=\"margin: 0px; line-height: 115%; font-family: "Calibri",sans-serif; font-size: 11pt;\"><b><font color=\"#000000\">n-invasive </font></b><u><b><font color=\"#000000\">V</font></b></u><b><font color=\"#000000\">entilation </font></b><u><b><font color=\"#000000\">I</font></b></u><b><font color=\"#000000\">n </font></b><u><b><font color=\"#000000\">C</font></b></u><b><font color=\"#000000\">hildren with </font></b><u><b><font color=\"#000000\">CE</font></b></u><b><font color=\"#000000\">rebral </font></b><u><b><font color=\"#000000\">M</font></b></u><b><font color=\"#000000\">alaria Trial</font></b></span></p>\n
      • laymans_summary<p>\n  </p>\n<p style=\"margin-left:10.6pt;\">\n <strong>A trial of non-invasive ventilation and in children with cerebral malaria (NOVICE-M)</strong></p>\n<h1>\n <span style=\"font-size:11px;\">What is the problem/background?</span></h1>\n<p style=\"margin-left:10.6pt;\">\n Children with cerebral malaria continue to have very poor outcomes. The SMAART: Severe Malaria in African children: A Research and Trials consortium have identified one key innovation which could improve this. We will explore the potential benefits of a special type of ventilation that applies suction or negative pressure to the chest (meaning keeping children breathing by pushing air in and out of their lungs) in combination with anticonvulsants given before children have had any fits, as a way to prevent them stopping breathing completely and/or preventing or reducing the amount of pressure that builds up in their brains which can lead to death, or brain damage and disability over the long-term.</p>\n<p style=\"margin-left:10.6pt;\">\n A device called biphasic Cuirass Ventilation (BCV) is a portable device that helps push air in and out of children’s lungs, without needing to put a tube down their throats. It does not need doctors to set it up, and can be used across a wide weight and age range. BCV is also used outside of hospitals by non-specialists (called paramedics) to help children breath. This technology innovation could be readily transferred to Africa to hospitals that have no access to the large and expensive machines that are used in high income countries to breathe for children (called mechanical ventilation). So BCV could be an alternative solution for ventilation in Africa, if studies showed that it could be safely and effectively implemented. BCV applies both negative and positive pressure to the chest, covering both inspiration (breathing in) and expiration (breathing out) phases of breathing, which is more appropriate for periods of when the breathing is too slow or stops for a period of time rather than other types of respiratory support. For example, a different kind of machine (called ‘CPAP’) is used in young infants with breathing difficulties. However, this only provides positive pressure and needs the child to be spontaneously breathing to benefit from it. During this trial we will be checking to see if the breathing is fully supported during the times it is too slow or stops. This may lead to a buildup of one of the gases that is breathed out called carbon dioxide. We will be monitoring this. If this does happen we will use another machine called AIRVO2 that produces High Flow air/oxygen mix to help reduce this build up of carbon dioxide. We will also be using a newer anticonvulsant drug to prevent seizures; this is called levetiracetam which has been used in Malawian children and shown to improve outcomes (reduces seizures and adverse events). This will be given directly into the stomach via a nasogastric tube (tubes down the nose into the stomach). The dose we will test first the standard dose that was safely used in the Malawian trial.</p>\n<p>\n  </p>\n<p style=\"margin-left:10.6pt;\">\n Given its potential to be transformative in improving current outcomes from cerebral malaria, a large group of specialist doctors in severe malaria research, together with world leaders in negative pressure ventilation research (Professor Brian Kavanagh, Sick Kids, Toronto and Professor John Fraser Critical Care Group, Brisbane) suggested that BCV should be tested. They have all helped to design this clinical trial, which will be conducted on the high dependency ward in Kilifi, Kenya.</p>\n<p>\n  </p>\n
      • short_titleNOVICE-M Trial
      • protocol_noECCT/18/08/01
      • version_no1.0
      • date_of_protocol19-06-2018
      • study_drugBiphasic Cuirass Ventilation
      • disease_conditionCerebral Malaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameBiphasic Cuirass Ventilation
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantProfessor Kathryn Maitland
      • declaration_date124-07-2018
      • declaration_principal_investigatorProfessor Kathryn Maitland
      • declaration_date224-07-2018
      • placebo_presentNo
      • study_objectives<h1>\n <span style=\"font-size:11px;\">GENERAL OBJECTIVES</span></h1>\n<p>\n  </p>\n<ol>\n <li>\n We aim to conduct a Phase I trial to demonstrate the feasibility and safety of non-invasive ventilatory support in cerebral malaria (Blantyre coma scale≤2) and history of seizures to generate preliminary data on seizure control and disability-free survival to 28 and 180 day</li>\n</ol>\n<h1>\n <span style=\"font-size:11px;\">SPECIFIC OBJECTIVES</span></h1>\n<p>\n  </p>\n<ol style=\"list-style-type:lower-roman;\">\n <li>\n To initially examine whether it is safe, feasible and practical to implement a protocol for the use of NPV with BCV, with or without the use of Hi-Flow AirVO2 technology (to treat hypercarbia (PCO2))</li>\n <li>\n To implement our refined-protocol for BCV use in cerebral malaria in addition to prophylactic anti- seizure treatment to reduce the complications of cerebral malaria</li>\n <li>\n To estimate the cumulative time with epileptogenic seizure activity using BCV, as determined by hourly or continuous monitoring with a EEG pod (captures and analyses EEG activity)</li>\n <li>\n To estimate the rate of adverse events using BCV, including episodes of bradypnoea or apnoea; hypoxaemia (oxygen saturations <92%); number of episodes of hypercarbia (pCo2>45mmHg since this will worse brain swelling), and number of aspiration events (given that all children will routinely having nasogastric tubes and regular suction)</li>\n</ol>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<h1>\n  </h1>\n
      • principal_inclusion_criteria<p>\n  </p>\n<p style=\"margin-left:52px;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">All of the following:</span></span></p>\n<p style=\"margin-left:52px;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">1.       Aged 3 months and 12 years admitted to the paediatric wards</span></span></p>\n<p style=\"margin-left:52px;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">2.       Current or recent evidence of <em>P. falciparum</em> malaria (slide or rapid diagnostic test (RDT) positive)</span></span></p>\n<p style=\"margin-left:52px;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">3.       Blantyre Coma Score 2 or less that persists even after correction for concurrent hypoglycaemia (defined as glucose <3 mmol/l)</span></span></p>\n<p style=\"margin-left:52px;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">4.       History of seizures in this illness</span></span></p>\n<p style=\"margin-left:52px;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">5.       Guardian or parent willing and able to provide consent</span></span></p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">            Any one of the following:</span></span></p>\n<p style=\"margin: 0px 0px 0px 52px; line-height: 115%;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px;\"><span style=\"margin: 0px;\"><font color=\"#000000\">1.</font><span new=\"\" times=\"\"><font color=\"#000000\">       </font></span></span></span><font color=\"#000000\">Known cerebral palsy or significant neuro-development delay (which will affect endpoint assessment)</font></span></span></p>\n<p style=\"margin: 0px 0px 0px 52px; line-height: 115%;\">\n  </p>\n<p style=\"margin: 0px 0px 0px 52px; line-height: 115%;\">\n  </p>\n<p style=\"margin: 0px 0px 0px 52px; line-height: 115%;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px;\"><span style=\"margin: 0px;\"><font color=\"#000000\">2.</font><span new=\"\" times=\"\"><font color=\"#000000\">       </font></span></span></span><font color=\"#000000\">Skin disease or burns preventing use of the BCV</font></span></span></p>\n<p style=\"margin: 0px 0px 0px 52px; line-height: 115%;\">\n  </p>\n<p style=\"margin: 0px 0px 0px 52px; line-height: 115%;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px;\"><span style=\"margin: 0px;\"><font color=\"#000000\">3.</font><span new=\"\" times=\"\"><font color=\"#000000\">       </font></span></span></span><font color=\"#000000\">Respiratory or cardio-respiratory arrest prior to enrolment</font></span></span></p>\n<p style=\"margin: 0px 0px 0px 52px; line-height: 115%;\">\n  </p>\n<p style=\"margin: 0px 0px 0px 52px; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px;\"><span style=\"margin: 0px;\"><font color=\"#000000\">      4.</font><span new=\"\" times=\"\"><font color=\"#000000\">       </font></span></span></span><font color=\"#000000\">A comorbidity which clinician believes has a significant risk of poor outcome e.g. malignancy, end-stage renal failure, major cardiac condition</font></span></span></p>\n<p>\n  </p>\n
      • primary_end_points<p style=\"margin: 0px; text-align: justify;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Primary endpoint</span></span></p>\n<p style=\"margin: 0px; text-align: justify;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\">C</font></span><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\">umulative time with epileptogenic seizure activity over 36 hours determined by hourly or continuous monitoring with a</font><span style=\"margin: 0px;\"><ins datetime=\"2018-04-15T10:46\"><font color=\"#008080\">n</font></ins></span><font color=\"#000000\"> EEG pod (that captures and analyses EEG activity).</font></span></span></span></p>\n<p style=\"margin: 0px; text-align: justify;\">\n  </p>\n<p style=\"margin: 0px; text-align: justify;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\">​Secondary endpoints</font></span></span></span></p>\n<p style=\"margin: 0px; text-align: justify;\">\n  </p>\n<p>\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\">Feasibility will be assessed by ability to implement/operationalise the BCV for use on the high dependency ward in Kilifi County Hospital (assessed by whether this can generate negative pressure ventilation as per specification by the Hayek recommendations and averts respiratory safety endpoints)<strong>. </strong></font></span></span></span></p>\n<p style=\"margin: 0px; text-align: justify;\">\n <span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\">Safety endpoints</font></span></span></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"font-size:16px;\"><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Aspiration (sudden decrease in oxygen saturations, and/or denovo presence of coarse chest crepitations, with evidence of gastric reflux/aspirate in the oropharynx)</font></font></span></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n  </p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Episodes of hypercarbia (defined as pCO2 level of greater than 45 mmHg)</font></span></font></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Episodes of bradypnoea and hypoxaemia (oxygen saturation <92%) in a child with unrousable coma (Blantyre coma scale≤2) (bradypnoea defined as <10, 15 or 20 breaths/minute over 3 minutes for those aged <6m, 6-36m and >36m respectively)</font></span></font></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Development of hypotension (defined as systolic blood pressure <50 mm Hg in children younger than 12 months; <60 mm Hg in children 1-5 years and <70 mm Hg in children olderthan 5 years of age)</font></span></font></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Use of additional anticonvulsants </font></span></font></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Neurological sequelae at day 180</font></span></font></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Day 28 and day 180 mortality</font></span></font></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Re-admission to hospital through day 180</font></span></font></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Serious adverse events through day 180</font></span></font></span></p>\n<p style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"margin: 0px; font-family: Wingdings;\"><span style=\"margin: 0px;\"><font color=\"#000000\">§</font><span new=\"\" style=\"margin: 0px; line-height: normal; font-family: \" times=\"\"><font color=\"#000000\">  </font></span></span></span><font color=\"#000000\">Grade 3/4 adverse events through day 180</font></span></font></span></p>\n<ul>\n <li style=\"margin: 0px 0px 0px 72px; line-height: 115%;\">\n <span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\"><span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px; line-height: 115%;\"><font color=\"#000000\">Length of initial hospitalisation</font></span></span></span></font></span></li>\n</ul>\n<p style=\"margin: 0px; text-align: justify;\">\n  </p>\n<p style=\"margin: 0px; text-align: justify;\">\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase I Feasibility and Safety Trial
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Clinicians (5)</p>\n<p>\n Professor Kathryn Maitland</p>\n<p>\n Dr. Mainga Hamaluba</p>\n<p>\n Dr. Nchafatso Obonyo</p>\n<p>\n Mohammed Bakari</p>\n<p>\n Emmanuel Omondi</p>\n<p>\n Nurses</p>\n<p>\n We have a pool of 15 nurses in the KEMRI High dependency Unit but we will also have two dedicated trial nurses. All the nurses will be trained on the study protocol and procedures.</p>\n<p>\n Dedicated trial nurses: Mwanamvua Boga and Kizito Mwangecho (Both are senior paediatric research nurses)</p>\n<p>\n Trial Coordinator</p>\n<p>\n Ayub Mpoya</p>\n<p>\n The trial willbe conducted in the KEMRI high dependency unit.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The study will be conduected in Kenya in children with cerebral malaria because it is directly related to their care in centres with no access to intensice care unitsthat have mechanical ventilation. This situation reflects the situation in most countries in Africa where malaria is endemic and cerebral malaria is a common cause of admission.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KEMRI - SERU (Scientific Ethics Review Unit) KEMRI/SERU/CGMR-C/123/3678 on 13th July 2018</p>\n<p>\n Imperial College Researcch Ethic Committee (ICREC) Reference number: 18IC4511 on 11th May 2018</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration15 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKilifi County Hospital
      • single_site_physical_addressP.O BOX 9 KILIFI
      • single_site_contact_personMr. Ayub Mpoya
      • single_site_telephone0735-229037
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site30
      • total_participants_worldwide30
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifyUnconscious children with cerebral malaria
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProfessor Kathryn
      • investigator1_middle_name
      • investigator1_family_nameMaitland
      • investigator1_qualificationMBBS, PhD, FRCP
      • investigator1_professional_addressKEMRI-WELLCOME TRUST RESEARCH PROGRAMME KILIFI P.OBOX 23O
      • investigator1_telephone0733-411022
      • investigator1_emailk.maitland@imperial.ac.uk
      • organisations_transferred_No
      • number_participants30
      • notification<p>\n None</p>\n
      • approval_date05-04-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-07-17 11:00:21
      • created2018-07-24 10:57:33
      • total_sites(null)
      • ecitizen_invoice380397
    • InvestigatorContact(array)
      • 0(array)
        • id446
        • application_id706
        • given_nameProfessor Kathryn
        • middle_name
        • family_nameMaitland
        • qualificationMBBS, PhD, FRCP
        • professional_addressKEMRI-WELLCOME TRUST RESEARCH PROGRAMME KILIFI P.OBOX 23O
        • telephone0733-411022
        • emailk.maitland@imperial.ac.uk
        • created2018-07-24 11:04:49
        • modified2020-03-09 11:00:21
    • SiteDetail(array)
      • 0(array)
        • id563
        • application_id706
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-07-24 11:04:49
        • modified2020-03-09 11:00:21
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id351
        • application_id706
        • sponsorImperial College London
        • sponsor_typeOthers
        • contact_personJoint Research Compliance Officer
        • addressRoom 221, Medical school building, Norfolk Place, London W21PG
        • telephone_number+44 207 594 1188
        • fax_number
        • cell_number+44 207 594 1188
        • email_addressjro@ic.ac.uk
        • created2018-07-24 11:04:49
        • modified2020-03-09 11:00:21
  • 3(array)
    • Application(array)
      • id834
      • user_id562
      • trial_status_id1
      • abstract_of_study<p>\n The East African Community (EAC) member states do not as a requirement conduct bioequivalent (BE) studies for generic medicines hence the quality of most of locally manufactured generic drugs is not fully established. This study aims to conduct a BE study of a locally-produced brand of enalapril 5mg tablets as an initial step of introduction of BE studies in EAC. The study will be an open-label, non-replicated, two-sequence, two-period crossover design with a seven-day washout period between each treatment phase. The study will enroll fourteen (14) healthy male adult volunteers aged 18 - 55 years with a body mass index of between 20and 30 kg/m<sup style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 8.26px;\"><font size=\"2\" style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 10.06px;\">2<strong style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 10.06px;\">.</strong></font></sup>Both drugs, brand and generic will be sourced from registered distributor. The reference pharmaceutical product will be Enam™ 5mg tablets while the local generic product will be Cardace™ 5mg tablets. One tablet of either the Cardace™ 5mg or Enam™ 5mg will be given orallyto the volunteers with 240 mL of water. A 5.0 mL blood sample for the enalapril assay will be drawn at time 0, 0.5, 1.0, 1.75, 2.25, 3,3.75, 5, 8, 12, and 24  hours dosing. The blood samples will be centrifuged at 1000 g for 10 minutes at room temperature and serum stored frozen at -35°C. After seven days, the study will be repeated in the same manner to complete the crossover design. Serum samples will be analyzed for enalapril plus its metabolite enaprilat, and the internal standard according to a validated Liquid chromatography-tandem mass spectrometry method.The following pharmacokinetic parameters will be calculated:elimination rate constant (Ke), maximum concentration (Cmax), time at maximum concentration (Tmax), elimination half-life (T<sub style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 8.26px;\"><font size=\"2\" style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 10.06px;\">1/2</font></sub>), area under the curve at time t (AUC0–t), and area under the curve extrapolated to infinity (AUC0–∞).Bioequivalence will be assessed by means of an analysis of variance (ANOVA) of the crossover design and estimating 90% confidence intervals for the ratio of the means of the test/reference products using log-transformed data. For AUC, the 90% confidence interval should be within the acceptance range 80-125%.</p>\n<p style=\"background-color: transparent; color: rgb(34, 34, 34); font-family: Arial,Verdana,sans-serif; font-size: 12px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;\">\n  </p>\n<p>\n  </p>\n
      • study_title<p>\n <span style=\"margin: 0px; line-height: 107%; font-family: "Bookman Old Style",serif; font-size: 10pt;\">A bioequivalent pilot study of a locally-produced brand of enalapril tablets:<span style=\"margin: 0px;\">  </span>a key step towards implementation of bioequivalent study regulatory requirements in East Africa</span></p>\n
      • laymans_summary<p>\n <span style=\"font-size:12px;\"><span style=\"background: white; line-height: 200%; font-family: "Times New Roman",serif;\">Currently, East African Community (EAC) member states do not have capacity to carry out studies known as bioequivalent (BE) studies for generic (copy of the original brands) medicines. These studies are very important as they show whether generic medicines are basically the same with original brands. Due to lack of this capacity the quality of locally manufactured medicines may not be fully known. </span><span style=\"line-height: 200%; font-family: "Times New Roman",serif;\">This study intends to conduct a BE study of a locally produced medication called enalapril (which is a drug for treatment of high blood pressure) a key step towards enforcement of BE requirements in East Africa. The study will enroll fourteen (14) healthy adult volunteers aged 18-55 years^.<span style=\"background:white\">Both drugs, brand and generic will be sourced from a registered distributor. The reference pharmaceutical product (or the original product) will be Enam™ 5mg tablets while the local generic product will be </span>Cardace<span style=\"background:white\">™ 5mg. </span>One tablet of either the Cardace<span style=\"background:white\">™ 5mg</span> or Enam™ 5mg will be given by mouth to the volunteers with 240 mL of water. A 5.0 mL blood sample for the enalapril assay will be drawn into EDTA-K3 anticoagulant tubes before and after taking medication. The blood samples will be processed and kept frozen. After seven days, the study will be repeated in the same manner with the alternative medication being tested. Blood samples will be analyzed for enalapril using a machine known as LC MS/MS. The scientists will then carry out calculation to determine the similarity between the generic and original products of enalapril tablets.</span><span style=\"line-height: 200%; font-family: "Times New Roman",serif;\"> </span><span style=\"line-height: 200%; font-family: "Times New Roman",serif;\">The results of this study will be shared with the Pharmacy & Poisons Board (the national Drug Regulatory Authority) as part of policy enforcers, for their information. However, our results will not affect the drugs registration status.</span></span></p>\n
      • short_titleA Pilot BE study for Enalpril 5mg
      • protocol_noECCT/19/11/03
      • version_noVersion 3.0
      • date_of_protocol07-08-2019
      • study_drugEnalapril 5mg (Enam and Cardace)
      • disease_conditionHypertension
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameEnalapril
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameEnam
      • comparator_registeredYes
      • comparator_countriesIndia, Uganda, and South Africa
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjhkimotho@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Simon Njoroge Njenga
      • declaration_date114-11-2019
      • declaration_principal_investigatorDr. James Hungo Kimotho, Study Coordinator
      • declaration_date214-11-2019
      • placebo_presentNo
      • study_objectives<h2>\n <span style=\"font-size:12px;\">Main Objective</span></h2>\n<p align=\"left\">\n To conduct a bioequivalent pilot study of a selected locally-produced brand of enalapril tablets on fasted subjects.</p>\n<p>\n <strong>Specific Objectives</strong></p>\n<ol>\n <li>\n  To demonstrate the feasibility of conducting bioequivalence studies in EAC</li>\n</ol>\n<ol>\n <li value=\"2\">\n To delineate challenges of implementing BE studies.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">Healthy males. The test to be done for someone to be a healthy volunteer will include HIV testing, malaria, random glucose, total blood count, renal profile, ECG, urinalysis.</font></span></p>\n<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">Aged between18 and 55 years</font></span></p>\n<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">BMI 20-30kg/m2</font></span></p>\n<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">Acceptance and sign informed consent </font></span></p>\n<p style=\"margin: 0px 0px 0px 24px; text-align: justify; line-height: 115%; text-indent: -0.25in;\">\n <span style=\"margin: 0px; line-height: 115%; font-family: Symbol;\"><span style=\"margin: 0px;\">·<span new=\"\" style=\"font: 7pt \" times=\"\">         </span></span></span><span style=\"background: white; margin: 0px; line-height: 115%;\"><font face=\"Calibri\">Non-smokers and without a history of alcohol or drug abuse</font></span></p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ul style=\"margin-top:0in\" type=\"disc\">\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">HIV positive or other immunosuppressive status </span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Symptomatic infection</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Concomitant exposure to other investigational medicinal products</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">History of alcohol or drug abuse</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Smokers</span></li>\n</ul>\n<ul style=\"margin-top:0in\" type=\"disc\">\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Known hypersensitivity to ACE inhibitors</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Laboratory result abnormalities, including clinically significant abnormal ECG, liver function tests more than x3 upper limit of normal, abnormal renal function tests.</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition. </span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Aged below 18yrs or above 55 years</span></li>\n <li style=\"margin: 0px; text-align: justify; color: rgb(0, 0, 0); line-height: 115%; font-family: \">\n <span style=\"background: white; margin: 0px; line-height: 115%;\">Inability to give informed consent</span></li>\n</ul>\n
      • primary_end_points<p>\n  </p>\n<p style=\"margin: 0px 0px 10.66px 48px; line-height: 115%; text-indent: -0.25in;\">\n <font color=\"#000000\"><span bookman=\"\" lang=\"EN-GB\" old=\"\" style=\"margin: 0px; line-height: 115%; font-family: \"><span style=\"margin: 0px;\">1.<span new=\"\" style=\"font: 7pt \" times=\"\">    </span></span></span><span new=\"\" style=\"background: white; margin: 0px; line-height: 115%; font-family: \" times=\"\">Pharmacokinetic data and BE demonstration</span></font></p>\n<p style=\"margin: 0px 0px 10.66px 48px; line-height: 115%; text-indent: -0.25in;\">\n <font color=\"#000000\"><span new=\"\" style=\"background: white; margin: 0px; line-height: 115%; font-family: \" times=\"\">2.     </span></font><span new=\"\" style=\"background: white; margin: 0px; line-height: 107%; font-family: \" times=\"\"><font color=\"#000000\">Shared experience of conducting Bioequivalence studies in Kenya</font></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence1
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:158px;\">\n <p>\n <strong>            Names</strong></p>\n </td>\n <td style=\"width:144px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:144px;\">\n <p>\n <strong>Experience</strong></p>\n </td>\n <td style=\"width:159px;\">\n <p>\n <strong>Roles</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Simon N. Njenga</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n MBcHB, MMED</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Experienced in conducting clinical trial</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Project PI</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Fredrick Kirui</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n MBcHB, MMED</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Experienced in conducting clinical trial</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Co Project PI</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. James H. Kimotho</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n B. Pharm, PhD (Mol Med]</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Researcher/Scientist</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Study Co-ordinator</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Veronica Manduku</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n MBcHB, MMED</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Experienced in conducting clinical trial</p>\n </td>\n <td style=\"width:159px;\">\n <p align=\"left\">\n Will carry out, clinical implementation, and participate in manuscript writing</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Sabina Wachira</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n BSc Chem, PhD</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Chemical Analysis/LCMS and Pharmacokinetics</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Development and validation of methods of analysis for the drugs that will be used in the BE studies. She will also be in-charge of the pharmacokinetic studies.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr.Jane Ongong’a</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n MBcHB, MMED</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Experienced in conducting clinical trial</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Independent study Monitor</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Cecilia Wanjala</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n B.Pharm, MBA</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Commercialization of Pharma products</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Commercialization of the BE studies at KEMRI</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Ms. Jacqueline Thiga</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n BSc, MSc</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Research Scientist</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Documentation and other publication</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Ms. Lucy Muita</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n BSc.</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Assistant Research Scientist</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Internal Quality Assurance of the study</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Felix Skuta</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n B. Pharm</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n Pharmacist</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Study Pharmacist</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:158px;\">\n <p>\n Dr. Matthew H. Kwena</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n B. Pharm, MPharm</p>\n </td>\n <td style=\"width:144px;\">\n <p>\n He work with the National Quality Control Laboratory - Analysis</p>\n </td>\n <td style=\"width:159px;\">\n <p>\n Development and validation of methods of analysis</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Not Applicable</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration6months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorEnamâ„¢ (enalapril)
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyCardaceâ„¢(enalapril)
      • single_site_member_stateYes
      • location_of_areaKenya Medical Research Institute
      • single_site_physical_addressP. O. Box 54840 – 00200, NAIROBI, Kenya, Off Mbagathi Rd
      • single_site_contact_personDr. James H. Kimotho
      • single_site_telephone(254) (020 2722541, 2713349, 0722-205901, 0733-400003
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site14
      • total_participants_worldwide14
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJames
      • investigator1_middle_nameHungo
      • investigator1_family_nameKimotho
      • investigator1_qualificationB.Pharm, PhD
      • investigator1_professional_addressDr.
      • investigator1_telephone+254722243365
      • investigator1_emailjhkimotho@kemri.org
      • organisations_transferred_No
      • number_participants14
      • notification
      • approval_date09-04-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy Approved although some documentation need to be provided when available
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-04-09 10:34:02
      • created2019-11-14 13:37:08
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id516
        • application_id834
        • given_nameSimon
        • middle_nameNjoroge
        • family_nameNjenga
        • qualificationMBChB, MMED
        • professional_addressDr
        • telephone+254722733213
        • emailsimon.n.njenga@gmail.com
        • created2019-11-14 13:57:57
        • modified2020-03-24 18:03:41
    • SiteDetail(array)
      • 0(array)
        • id678
        • application_id834
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-11-14 13:57:57
        • modified2020-03-24 18:03:41
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id404
        • application_id834
        • sponsorKEMRI/East Africa Community and Partners
        • sponsor_typeResearch Institution
        • contact_personDr. James H. Kimotho
        • addressKEMRI, P. O. Box 54840 00200 Nairobi
        • telephone_number(254) (020 2722541
        • fax_number(254) (020) 2720030
        • cell_number+254722243365
        • email_addressjhkimotho@kemri.org
        • created2019-11-14 13:57:57
        • modified2020-03-24 18:03:41
  • 4(array)
    • Application(array)
      • id1044
      • user_id73
      • trial_status_id7
      • abstract_of_study<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Pre-exposure prophylaxis (PrEP) using co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) is a potent HIV prevention method for men and cisgender women, with its efficacy highly dependent on adherence. Pivotal studies that combined clinical epidemiology and pharmacology defined thresholds for PrEP protection in men who have sex with men (MSM) that have been key to PrEP promotion and development of new PrEP agents. For African cisgender women at risk for HIV, a priority group due to disproportionately high incident HIV infections, variable adherence in PrEP clinical trials and limited pharmacologic data have resulted in lack of clarity about levels of PrEP use required for HIV protection. Single-dose tissue pharmacology studies suggest oral TDF/FTC PrEP dosing delivers 20- to 100-fold higher TFV-DP in rectal tissue compared with vaginal tissue, suggesting cisgender women may need extraordinary perfection for HIV protection; on the other hand, in clinical studies in cisgender women with reasonable-but-imperfect PrEP adherence, suggest important levels of HIV protection. Thus, understanding the pharmacological-HIV protection relationship for cisgender women is essential. We will conduct an open-label, randomized, three-arm, directly observed pharmacological study of TDF/FTC PrEP in African cisgender women. The primary objectives: 1) To define the cisgender women-specific expected blood concentrations and dose-proportionality for TFV-DP in DBS and PBMCs using directly observed TDF/FTC therapy at 2, 4, 7 doses per week. 2) To establish a model to predict adherence rate to TDF/FTC by level of TFV-DP in DBS for cisgender women. HIV-uninfected non-pregnant cisgender women will be randomly assigned to 1 of 3 dosing frequencies of directly observed therapy (DOT) TDF/FTC PrEP: 2, 4, or 7 doses/week to help differentiate poor and modest from perfect adherence. An additional contemporaneous cohort of pregnant cisgender women to receive daily dosing will also be recruited to evaluate the impact of pregnancy on blood and cellular drug levels. The study will enroll two cohorts of 18-30 years old HIV uninfected cisgender women at Thika site in Kenya: 1) Up to 54 non-pregnant cisgender women at low risk of HIV and 2) Up to 18 pregnant cisgender women at elevated risk of HIV and willing to use PrEP. The proposed study will be the first to define TDF-PrEP adherence-blood concentration thresholds for African cisgender women, a priority population for HIV prevention. The findings will guide accurate interpretation of adherence and success of PrEP programs in cisgender women. This data will also help guide decisions on optimal PrEP dosing for HIV at-risk pregnant cisgender women in Africa.</span></span></p>\n
      • study_title<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Pharmacology of TDF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women</span></span></p>\n
      • laymans_summary<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">African cisgender women are disproportionately affected with HIV and have an elevated risk of acquiring HIV in pregnancy. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy, but variable adherence in PrEP clinical trials among African cisgender women and limited pharmacologic data have resulted in lack of clarity about the degree of PrEP use required for HIV protection in cisgender women. For men who have sex with men, the STRAND study defined the adherence levels to PrEP medication and expected drug concentrations arising from varying directly observed therapy (DOT) doses per week. Those thresholds are today being applied to studies of African cisgender women taking PrEP, and cisgender women-specific levels associated with HIV prevention have never been defined. However, recent data from large PrEP studies we have done among African cisgender women ─including Partners PrEP Study and Partners Demonstration Projects conducted at Thika site─, suggest that these levels may not reflect the pharmacology of cisgender women in African settings, in general and particularly in pregnancy. In these studies in African populations, PrEP dosing was not directly observed therapy and no study has established expected PrEP concentrations in African cisgender women with varying frequency of PrEP adherence. Thus, there is an urgent need to define the frequency of adherence and expected blood concentrations of PrEP medications and their relationship to HIV protection in non-pregnant and pregnant cisgender women. </span></span></p>\n
      • short_titleWomen TDF/FTC Benchmark Study
      • protocol_noECCT/21/09/03
      • version_no1.0
      • date_of_protocol20-05-2021
      • study_drugBenchmark Study - TDF/FTC
      • disease_conditionHIV prevention
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTD/FTC
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPeter Mogere
      • declaration_date109-09-2021
      • declaration_principal_investigatorDr. Nelly Mugo
      • declaration_date209-09-2021
      • placebo_presentNo
      • study_objectives<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Primary objectives:</strong></span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">1. To define the cisgender women-specific expected blood concentrations and dose-proportionality for TFV-DP in dried blood spots (DBS) and PBMCs using directly observed TDF/FTC therapy at 2, 4, 7 doses per week.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">2. To establish a model to predict adherence rate to TDF/FTC by level of TFV-DP in DBS for cisgender women.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Secondary objectives:</strong></span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">1. To define the expected concentrations and dose-proportionally for TFV-DP in PBMCs and vaginal tissue.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">2. To quantify the effect of pregnancy on the benchmark concentrations of TFV, TFV-DP, FTC, and FTC-TP in pregnant cisgender women using daily DOT TDF/FTC </span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">3. Examine relationships among drug concentrations in plasma, whole blood (WB), DBS, and PBMCs.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">4. To determine the influence of biological variables (e.g. mean corpuscular volume and hematocrit, age, weight, sex) on drug concentrations.</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">5. Compare drug concentrations in DBS from fingerstick versus transferring blood from blood tubes.</span></span></p>\n
      • principal_inclusion_criteria<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Inclusion criteria for the pregnant cohort</strong></span></span></p>\n<ul>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Age ≥18 and ≤30 years</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV uninfected</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Has an active smart phone</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Normal renal function (GFR >60ml/min)</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Hepatitis B surface Ag negative</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">High risk for HIV</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Pregnant at 13-26 weeks of gestation</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Willing to use DOT and come to clinic daily for DOT PrEP for 8 weeks</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Willing to have home visits/video streaming if clinic visit not feasible</span></span></p>\n </li>\n</ul>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Inclusion criteria for the non- pregnant cohort</strong></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Age ≥18 and ≤30 years</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV uninfected</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Has an active smart phone</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Normal renal function (GFR >60ml/min)</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Hepatitis B surface Ag negative</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Low risk for HIV</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Not pregnant or breastfeeding</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Willing to be randomized to non-daily PrEP and come to clinic frequently for DOT PrEP</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size: 14px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Willing to have home visits/video streaming if clinic visit not feasible</span></span></span></span></li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Exclusion criteria for pregnant women</strong></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Inability to give informed consent</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Current or past use of PrEP (pre-exposure prophylaxis)</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Not willing to have home visit</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Sickle cell anemia, chronic bleeding, blood transfusion within the past 120 days (excluding for chronic illness) or other blood dyscrasias</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Fetus has a known or suspected major congenital anomaly defined by fetal ultrasound. </span></span></li>\n</ul>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Exclusion criteria for non-pregnant women</strong></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Inability to give informed consent</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV positive test at screening or suspected acute HIV infection in the opinion of the clinician</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Concomitant medications taken within 30 days of enrollment: aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (>800mg acyclovir or > 500mg valacyclovir for >7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Current or past use of PrEP (pre-exposure prophylaxis)</span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">pregnancy/plan to become pregnant in the next 6 months/unwillingness to use birth control</span></span></li>\n</ul>\n
      • primary_end_points<ul>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Define benchmark concentrations of TFV-DP in DBS and PBMCs, and the dosing frequency (i.e., doses per week) required to generate them.  </span></span></li>\n <li>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Define how pregnancy affects the expected blood levels to help define optimal dosing of PrEP for HIV prevention during pregnancy.</span></span></li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n KEMRI-CCR Partners in Health & Research Development - PHRD (Formerly Partners in Prevention) Thika Project, has 64 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc).</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Principal Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n                                         Dr. Elizabeth Irungu MBChB, MPH, PHD</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Coordinator: Dr. Catherine Kiptinness, BPharm, MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Regulatory Lead: Peter Mogere, DPharm., B.Sc</p>\n
      • other_details_explanation<div style=\"margin-left:.25in;\">\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Adolescent girls and young women (AGYW) are only 10% of sub-Saharan population yet they account for 24% of new HIV infections¹. In Kenya, AGYW(10-24 years) have a 2.2-fold higher incidence of HIV than their male counterparts and represent 1/3 of all annual new infections^2-3.Pre-exposure prophylaxis (PrEP) is an effective and recommended strategy for HIV prevention and only works when taken as recommended. TDF/FTC as PrEP is the currently approved combination drug product for women. Recent clinical studies in African cisgender women with reasonable but imperfect PrEP adherence, there is evidence to suggest important levels of HIV protection. I</span></span><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14px;\">n pregnancy TFV-DP levels are even lower. </span><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14px;\">Previous studies have defined adherence concentration thresholds among MSMs. Women may require higher adherence levels for similar PrEP efficacy than MSM because of lower active drug concentrations in genital versus rectal tissues.  There is lack of data on minimum dose required to confer protection against HIV in women from the previous trials. </span><span style=\"font-family: arial, helvetica, sans-serif; font-size: 14px;\">Thus, there is an urgent need to define the frequency of adherence and expected blood concentrations of PrEP medications and their relationship to HIV protection in non-pregnant and pregnant cisgender women. The trial seeks to fill this gap using TDF-FTC daily observed therapy (DOT) in women.</span></div>\n<div style=\"margin-left:.25in;\">\n <table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <tbody>\n <tr>\n <td>\n <p style=\"color: rgb(32, 31, 30); font-size: 12pt; font-family: Calibri, sans-serif; margin: 0px;\">\n <span style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 11pt; line-height: inherit; font-family: Arial, sans-serif; vertical-align: baseline; color: inherit;\">1. <span style=\"font-size:10px;\">UNAIDS, 2020</span></span></p>\n <p style=\"color: rgb(32, 31, 30); font-size: 12pt; font-family: Calibri, sans-serif; margin: 0px;\">\n <span style=\"font-size:10px;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; line-height: inherit; font-family: Arial, sans-serif; vertical-align: baseline; color: inherit;\">2. UNAIDS. AIDSInfo-Kenya [Internet]. Available from: https://aidsinfo.unaids.org</span></span></p>\n <p style=\"color: rgb(32, 31, 30); font-size: 12pt; font-family: Calibri, sans-serif; margin: 0px;\">\n <span style=\"font-size:10px;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; line-height: inherit; font-family: Arial, sans-serif; vertical-align: baseline; color: inherit;\">3. Kenya Population-based HIV Impact Assessment (KENPHIA) Preliminary Report 2018 [Internet]. Kenya Ministry of Health, National AIDS and STI Control Program; Available from: https://www.nascop.or.ke/kenphia-report/</span></span></p>\n </td>\n </tr>\n </tbody>\n </table>\n <p>\n  </p>\n</div>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">University of Washington IRB</span></span></p>\n
      • other_details_regulatory_approved<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Kenya Medical Research Institute</span></span></p>\n<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Approval date: 22/07/2021</span></span></p>\n
      • other_details_regulatory_rejected<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">None</span></span></p>\n
      • other_details_regulatory_halted<p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">N/A</span></span></p>\n
      • estimated_duration2 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-CCR PHRD (THIKA) PROJECT
      • single_site_physical_addressThika Section 9, OAU Road, Near Thika Nursing Home
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone+254 722362219
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site72
      • total_participants_worldwide72
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameKenneth
      • investigator1_middle_name
      • investigator1_family_nameMugwanya
      • investigator1_qualificationMBChB, MS,PhD
      • investigator1_professional_addressUniversity of Washington 325 Ninth Avenue; Box 359927 Seattle, WA 98104, USA
      • investigator1_telephone206-520-3886
      • investigator1_emailmugwanya@uw.edu
      • organisations_transferred_Yes
      • number_participants72
      • notification
      • approval_date19-12-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-10-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-02-27 17:18:12
      • created2021-08-06 08:51:36
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id706
        • application_id1044
        • given_nameNelly
        • middle_name
        • family_nameMugo
        • qualificationMBChB, MMeD, MPH
        • professional_addressKEMRI-CCR
        • telephone+254722823770
        • emailrwamba@uw.edu
        • created2021-08-06 10:49:52
        • modified2021-10-08 09:25:57
    • SiteDetail(array)
      • 0(array)
        • id1089
        • application_id1044
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-08-06 10:49:52
        • modified2021-10-08 09:25:57
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id529
        • application_id1044
        • sponsorUniversity of Washington
        • sponsor_typeResearch Institution
        • contact_personDr. Nelly Mugo
        • addressKEMRI-CCR
        • telephone_number+254 722823770
        • fax_number
        • cell_number+254 722823770
        • email_addressrwamba@uw.edu
        • created2021-08-06 10:49:52
        • modified2021-10-08 09:25:57
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(empty)
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php