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  • trial_therapeutic_use1

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• trial_statuses(array)
  • 1Recruiting
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  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
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• applications(array)
  • 0(array)
    • Application(array)
      • id294
      • user_id38
      • trial_status_id7
      • abstract_of_study<p>\n Less than a year after Artemisinin-based combination therapies (ACTs) were recommended for the treatment of falciparum malaria, concerns about artemisinin resistance development along the Cambodian-Thai border were voiced. Artemisinin resistance has been poorly characterized, and is difficult to detect by classical laboratory approaches.  In-vitro tests have not consistently detected reduced pharmacodynamic responses to artemisinin drugs, and molecular markers conferring artemisinin resistance have not yet been determined.  This study aims to assess the degree of artemisinin resistance in adult and pediatric subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study treatments will be Artemether Lumefantrine (AL) and Artesunate Mefloquine (ASMQ). In order to accurately evaluate the artemisinin derivative without the confounding influence of the partner drug, ASMQ will be sequentially administered. In-vivo and in-vitro methodologies, including pharmacokinetic methods, will be employed. Data generated from this study, both on its own and when compared to and pooled with data from similar studies that will be conducted in Ghana, Peru and Thailand, will potentially enable the identification of key markers that may assist in the early detection of resistance, and also to better understand the development of resistance to ACTs, and thus inform both local and international policy regarding ACT use.</p>\n
      • study_title<p>\n In vivo and in vitro efficacy of artemisinin combination therapy in Kisumu County, Western Kenya.</p>\n
      • laymans_summary(null)
      • short_titleInvivo I study
      • protocol_noECCT/14/05/02
      • version_no3.5
      • date_of_protocol10-02-2014
      • study_drugArtemether Lumefantrine and Artesunate Mefloquine
      • disease_conditionMalaria
      • 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_nameArtemether Lumefantrin and Artesunate Mefloquine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@usamru-k.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_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_applicantVictorine Owira
      • declaration_date114-05-2014
      • declaration_principal_investigatorDr Ben Andagalu
      • declaration_date214-05-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Adult/child aged between 6 months and 65 years inclusive (minimum weight 11kg), presenting with a measured temperature of ≥37.5⁰C, or history of fever within 24 hours prior to presentation</li>\n <li>\n Mono-infection with Plasmodium falciparum (refer to section 7.6.10.2.1 below)</li>\n <li>\n Baseline parasitemia of 2000 - 200,000 asexual parasites/µl</li>\n <li>\n Ability to provide informed consent</li>\n <li>\n Willingness and ability to comply with the study protocol for the duration of the study</li>\n <li>\n Willingness to remain in the hospital for 3 days</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Presence of signs of severe malaria as defined in section 7.3.2.1 below</li>\n <li>\n Presence of severe anemia, defined as hemoglobin level below 6 g/dl</li>\n <li>\n Presence of mixed Plasmodium infection, or mono-infection of non-falciparum Plasmodium</li>\n <li>\n Inability to take oral medication</li>\n <li>\n History of allergy or contraindications to the study treatments</li>\n <li>\n Lactating or pregnant females</li>\n <li>\n Any condition that the investigator feels will result in an unfavorable outcome should the potential subject participate in the study</li>\n</ul>\n
      • primary_end_points<p>\n The primary study endpoint is the time to parasitaemia clearance from day 0 after treatment initiation. Parasitaemia clearance is defined as the parasitaemia disappearance at day 1, day 2 and up to day 28 after treatment.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • 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_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The study site is well equiped to handle phase I to phase IV clinical trials. It has fully equiped clinical laboratory with functional hematology, biochemistry, microbiology and microscopy department. The site also has access to a level 2 basic science laboratory situated in the town office which is about 40 km from the research site. There is clinical pharmacy, consultation rooms, nursing station, emergency room equiped with emergency kits.</p>\n<p>\n The study has 7 investigators, 1 clinical research coordinator, 1 internal quality control personnel, 5 laboratory technologists, 1 pharmacyst, 3 pharm techs, 5 clinical officers, 7 nurses and numerous field workers</p>\n
      • other_details_explanation<p>\n The study is local investigator initiated</p>\n
      • other_details_regulatory_notapproved<p>\n Not Applicable</p>\n
      • other_details_regulatory_approved<p>\n Not Applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration42 days per partcipant
      • 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_areaKombewa Clinical Research Center
      • single_site_physical_addressOff Kisumu Bondo road opposite Kombewa District Hospital
      • single_site_contact_personDr Ben Andagalu
      • single_site_telephone+254716004851
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site118
      • total_participants_worldwide118
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • 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_nameBen
      • investigator1_middle_name
      • investigator1_family_nameAndagalu
      • investigator1_qualificationMD,MSc
      • investigator1_professional_address54-40100 Kisumu, Kenya
      • investigator1_telephone+254716004851
      • investigator1_emailBen.Andagalu@usamru-k.org
      • organisations_transferred_No
      • number_participants118
      • notification
      • approval_date14-07-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted14-05-2014
      • 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)
      • modified2016-04-03 05:48:21
      • created2014-05-14 08:50:04
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id203
        • application_id294
        • given_nameBen
        • middle_name
        • family_nameAndagalu
        • qualificationMD, MSc
        • professional_address54-40100 Kisumu, Kenya
        • telephone+254716004851
        • emailBen.Andagalu@usamru-k.org
        • created2014-05-14 08:56:10
        • modified2014-05-14 18:40:59
    • SiteDetail(array)
      • 0(array)
        • id252
        • application_id294
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-05-14 08:56:10
        • modified2014-05-14 18:40:59
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id162
        • application_id294
        • sponsorDepartment of Emerging Infectious Diseases of the United States Army Medical Research Unit
        • sponsor_type(null)
        • contact_personCOL Roddney Coldren
        • address54-40100 Kisumu
        • telephone_number+254-20-272-9303
        • fax_number+254-20-271-4592
        • cell_number+254 (0)700 881955
        • email_addressrodney.coldren@usamru-k.org
        • created2014-05-14 08:56:10
        • modified2014-05-14 18:40:59
  • 1(array)
    • Application(array)
      • id296
      • user_id38
      • trial_status_id7
      • abstract_of_study<p>\n Less than a year after Artemisinin-based combination therapies (ACTs) were recommended for the treatment of falciparum malaria, concerns about artemisinin resistance development along the Cambodian-Thai border were voiced. Artemisinin resistance has been poorly characterized, and is difficult to detect by classical laboratory approaches.  In-vitro tests have not consistently detected reduced pharmacodynamic responses to artemisinin drugs, and molecular markers conferring artemisinin resistance have not yet been determined.  This study aims to assess the degree of artemisinin resistance in adult and pediatric subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study treatments will be Artemether Lumefantrine (AL) and Dihydroartemisinin Piperaquin (DHA PPQ). In-vivo and in-vitro methodologies, including pharmacokinetic methods, will be employed. Data generated from this studywill potentially enable the identification of key markers that may assist in the early detection of resistance, and also to better understand the development of resistance to ACTs, and thus inform both local and international policy regarding ACT use.</p>\n
      • study_title<p>\n Therapeutic efficacy of dihydroartemisinin piperaquine and artemether lumefantrine for the treatment of uncomplicated malaria  in Kisumu County, Western Kenya</p>\n<p>\n Therapeutic efficacy of dihydroartemisinin piperaquine and artemether lumefantrine for the treatment of uncomplicated malaria  in Kisumu County, Western Kenya</p>\n
      • laymans_summary(null)
      • short_titleInvivo II study
      • protocol_noECCT/14/05/03
      • version_no3.3
      • date_of_protocol24-03-2014
      • study_drugArtemether Lumefantrine and Dihydroartemisinin Piperaquin
      • disease_conditionMalaria
      • 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_nameArtemether Lumefantrine and Dihydroartemisinin Piperaquin
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@usamru-k.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_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_applicantVictorine Owira
      • declaration_date115-05-2014
      • declaration_principal_investigatorDr Ben Andagalu
      • declaration_date215-05-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Adult/child aged between 6 months and 65 years inclusive (minimum weight 11kg), presenting with a measured temperature of ≥37.5⁰C, or history of fever within 24 hours prior to presentation</li>\n <li>\n Mono-infection with <em>Plasmodium falciparum</em> (refer to section 7.6.11.2.1 below)</li>\n <li>\n Baseline parasitemia of 2000 - 200,000 asexual parasites/µl</li>\n <li>\n Ability to provide informed consent</li>\n <li>\n Willingness and ability to comply with the study protocol for the duration of the study</li>\n <li>\n Willingness to remain in the hospital for 3 days</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Presence of signs of severe malaria as defined in section 7.3.2.1 below</li>\n <li>\n Presence of severe anemia, defined as hemoglobin level below 6 g/dl</li>\n <li>\n Presence of mixed Plasmodium infection, or mono-infection of non-falciparum Plasmodium</li>\n <li>\n Inability to take oral medication</li>\n <li>\n History of allergy or contraindications to the study treatments</li>\n <li>\n Lactating or pregnant females</li>\n <li>\n Any condition that the investigator feels will result in an unfavorable outcome should the potential subject participate in the study</li>\n</ul>\n
      • primary_end_points<p>\n The primary study endpoint is the time to parasitaemia clearance from day 0 after treatment initiation. Parasitaemia clearance is defined as the parasitaemia disappearance at day 1, day 2 and up to day 28 after treatment</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • 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_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The kombewa clinical research is well equiped to run phase I to phase IV clinical trials. It has fully equiped clinical laboratory with hematology, biochemestry, microbiology and microcopy departments. The center also has a fully equiped clinical research pharmacy with an emergency room and upto date emergency kits, consultation rooms, nursing station, document storage area, consenting rooms and briefing hall.</p>\n<p>\n The study has 7 investigators, 1 clinical research coordinator, 7 nurses, 5 laboratory personnel, 1 internal quality control personnel, 5 clinical officers, 1 pharmacyst and 3 pharm techs</p>\n
      • other_details_explanation<p>\n The study is an investigator initiated efficacy study.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration42 days per partcipant
      • 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_areaKombewa Clinical Research Center
      • single_site_physical_addressOff Kisumu Bondo road opposite Kombewa District Hospital
      • single_site_contact_personDr Ben Andagalu
      • single_site_telephone+254716004851
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site118
      • total_participants_worldwide118
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • 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_nameBen
      • investigator1_middle_name
      • investigator1_family_nameAndagalu
      • investigator1_qualificationMD,MSc
      • investigator1_professional_address54-40100 Kisumu, Kenya
      • investigator1_telephone+254716004851
      • investigator1_emailBen.Andagalu@usamru-k.org
      • organisations_transferred_No
      • number_participants118
      • notification
      • approval_date14-07-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-05-2014
      • 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)
      • modified2016-04-05 23:05:22
      • created2014-05-14 18:44:21
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id206
        • application_id296
        • given_nameBen
        • middle_name
        • family_nameAndagalu
        • qualificationMD, MSc
        • professional_address54-40100 Kisumu, Kenya
        • telephone+254716004851
        • emailBen.Andagalu@usamru-k.org
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
    • SiteDetail(array)
      • 0(array)
        • id255
        • application_id296
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id165
        • application_id296
        • sponsorDepartment of Emerging Infectious Diseases of the United States Army Medical Research Unit
        • sponsor_type(null)
        • contact_personCOL Roddney Coldren
        • address54-40100 Kisumu
        • telephone_number+254-20-272-9303
        • fax_number+254-20-271-4592
        • cell_number+254 (0)700 881955
        • email_addressrodney.coldren@usamru-k.org
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
  • 2(array)
    • Application(array)
      • id286
      • user_id172
      • trial_status_id6
      • abstract_of_study<h1>\n Summary</h1>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Design:                       </strong>Randomized clinical trial involving hospitalized HIV-1 infected children.  Children will be randomized to randomized to urgent (<48 hours) versus early antiretroviral therapy (7-14 days).  This trial will be unblinded.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Population:                </strong>Hospitalized HIV-1 infected children who are antiretroviral therapy (ART) naïve ≤ 12 years of age.</p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Sample size:              </strong>360 children will be randomized (180 per arm). </p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Treatment:                 </strong>All children will be treated with ART according to World Health Organization (WHO) and Kenyan national guidelines.   </p>\n<p>\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Study duration:         </strong>Enrollment into the study will occur over the course of 36-48 months and each child will be routinely followed for a maximum of 6 months.</p>\n<p style=\"margin-left:1.5in;\">\n  </p>\n<p style=\"margin-left:1.5in;\">\n <strong>Study sites:</strong>               Kenyatta National Hospital, Kisumu District Hospital, Nyanza Provincial Hospital)</p>\n
      • study_title<p>\n POST STABILIZATION VERSUS URGENT START OF HAART IN HIV-1 INFECTED CHILDREN WITH SEVERE COINFECTION</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/14/07/01
      • version_noVERSION 3.0
      • date_of_protocol01-08-2012
      • study_drugANTIRETROVIRALS
      • 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_nameANTIRETROVIRALS
      • product_type_medical_device_nameN/A
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmoraahelen@yahoo.com
      • 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_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 Dalton Wamalwa
      • declaration_date126-06-2014
      • declaration_principal_investigatorDr Dalton Wamalwa
      • declaration_date226-06-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Inclusion Criteria</p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Aged ≤ 12 years old (reported)</li>\n <li>\n HIV-1 positive (for example, two rapid HIV-1 antibody tests for children >18 months and not breastfeeding, or one HIV-1 DNA/RNA test for children ≤18 months or who are breastfeeding)</li>\n <li>\n No prior ART (history of pMTCT antiretroviral treatment does not affect eligibility)</li>\n <li>\n Eligible to receive ART, according to current WHO guidelines</li>\n <li>\n Caregiver plans to reside in study catchment area for at least 6 months (reported)</li>\n <li>\n Caregiver provides sufficient locator information</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Exclusion Criteria:Â Suspected central nervous system infection (meningitis, encephalitis or other)</p>\n
      • primary_end_points<p>\n IRIS</p>\n<p>\n All cause mortality</p>\n<p>\n Drug toxicity</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • 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 Grace John-Stewart, BS, MD, MPH, PhD - Principal Investigator<br />\n Dalton Wamalwa, MBChB, MMed (Paeds), MPH - Site Principal Investigator<br />\n Lisa Ann Mills MD , MS - Co-Investigator<br />\n Jennifer Ann Slyker - Co-Investigator<br />\n Irene Njuguna, MBChB, MSc - Study Physician<br />\n Lisa M Cranmer, BS, MD, MPH - Study Physician<br />\n Vincent Otieno, MBChB - Study Physician<br />\n Daisy Jelagat Chebet, Dip. Clinical Medicine and Surgery - Clinical Officer<br />\n Judith Adhiambo, Dip. Clinical Medicine and Surgery, BA Soc and Psych - Clinical Officer<br />\n Benard Agony Dip. Clinical Medicine and Surgery - Clinical Officer<br />\n Helen Moraa, BSN - Study Coordinator<br />\n Clement Eweh Zeh - Laboratory Director<br />\n Esther Isarwa, KRN, - Study Nurse<br />\n Petronilla Wambulwa, KECN - Study Nurse<br />\n Sarah Njoki Mwangi - Recruitment Nurse<br />\n Beatrice Walimbwa, Cert in Med Lab - Technician Clinic Assistant/Phlebotomy<br />\n Simon Wahome, BPharm - Pharmacist<br />\n Nypha Mmayi , Pharm - Back up Pharmacist<br />\n Brian Muhanji - Lab Technologist<br />\n John Gatimu - Lab Technologist<br />\n Jackline Ouma - Pharmaceutical Technologist<br />\n Suzan Atinga - Nurse Counselor<br />\n Millicent Okongo - Nurse Counselor</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KNH/UoN Ethics and Research Committee - date of approval, 16th February 2013</p>\n<p>\n UNIVERSITY OF WASHINGTON IRB -Â 17th May 2012</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3.5 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorURGENT ART (48 HOURS), EA
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • 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_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site120 - Kenyatta National Hospital\n120 - Kisumu District Hospital\n120 - Jaramogi Oginga Odinga Teaching and Referral Hospital
      • total_participants_worldwide360
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • 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_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDalton
      • investigator1_middle_name
      • investigator1_family_nameWamalwa
      • investigator1_qualificationMmed, MPH Epidemiology
      • investigator1_professional_address19676 -00202
      • investigator1_telephone020- 273-1498
      • investigator1_emaildalton@africaonline.co.ke
      • organisations_transferred_Yes
      • number_participants360
      • notification
      • approval_date21-10-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-07-2014
      • 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)
      • modified2015-09-04 11:01:23
      • created2014-03-24 10:33:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id199
        • application_id286
        • given_nameGrace
        • middle_name
        • family_nameJohn-Stewart
        • qualificationPhD
        • professional_address325-Ninth Ave, Box 359909, Seattle WA, 98104 USA
        • telephone+1- 206-543-4278
        • emailgjohn@uw.edu
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
    • SiteDetail(array)
      • 0(array)
        • id245
        • application_id286
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressKenyatta National Hospital Grounds
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id246
        • application_id286
        • county_id42
        • site_nameJaramogi Odinga Teaching and Referral Hospital
        • physical_addressKisumu Kakamega Road
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 11:53:29
        • modified2014-07-31 15:36:36
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id247
        • application_id286
        • county_id42
        • site_nameKisumu East District Hospital
        • physical_addressKisumu
        • contact_details19676-00200
        • contact_personDr Dalton Wamalwa
        • site_capacity(null)
        • misc(null)
        • created2014-03-24 11:53:29
        • modified2014-07-31 15:36:36
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id158
        • application_id286
        • sponsorNational Institute of Health
        • sponsor_type(null)
        • contact_personLynne M. Mofenson MD Chief, Maternal and Pediatric Infectious Disease Branch
        • addressNational Institutes of Health 6100 Executive Boulevard, Room 4B11 Rockville, MD 20852
        • telephone_numberTelephone: 301-435-6870
        • fax_number
        • cell_numberN/A
        • email_addressLM65D@nih.gov
        • created2014-03-24 10:33:53
        • modified2014-07-31 15:36:36
  • 3(array)
    • Application(array)
      • id350
      • user_id224
      • trial_status_id7
      • abstract_of_study<p>\n Acute venous thromboembolism (i.e. deep-vein thrombosis [DVT] or pulmonary<br />\n embolism [PE]) is a common disorder with an annual incidence of approximately 1<br />\n or 2 cases per 1000 persons in the general population and is the third most common<br />\n cause of vascular death after myocardial infarction and stroke. The current standard<br />\n treatment for DVT is overlapping parenteral anticoagulation (e.g. LMWH) and a<br />\n vitamin K antagonist (e.g. warfarin). Parenteral anticoagulation needs to be<br />\n continued for 5 to 7 days, at least until an INR of 2.0 has been obtained, followed by<br />\n a minimum of 3 months of treatment with the vitamin K antagonist. Treatment with<br />\n vitamin K antagonists requires frequent monitoring of the international normalized<br />\n ratio (INR), and multiple interactions of vitamin K antagonists with foods and other<br />\n drugs have been reported. The duration of treatment is determined by individual risk<br />\n factors of the patient.<br />\n Rivaroxaban is a direct factor Xa inhibitor, and has been approved first in the<br />\n prevention of venous thromboembolism after elective hip and knee replacement<br />\n surgery. It does not require routine laboratory monitoring and has no food<br />\n interactions and only a few drug interactions compared to standard of care.<br />\n As part of the development program, the EINSTEIN clinical trial program was<br />\n designed to evaluate the use of rivaroxaban for the acute treatment and secondary<br />\n prevention of DVT (EINSTEIN-DVT) and PE (EINSTEIN-PE) and in long-term<br />\n secondary prevention of recurrent DVT and PE (EINSTEIN-EXT). A unique aspect<br />\n of the EINSTEIN-DVT and PE studies is the use of rivaroxaban as a single agent<br />\n (single drug approach) in contrast to the use of intravenous anticoagulants and<br />\n VKAs.<br />\n The EINSTEIN-DVT study demonstrated that rivaroxaban is at least as effective as<br />\n the current standard therapy with similar safety, in the treatment and secondary<br />\n prevention of DVT. The EINSTEIN PE study demonstrated non-inferior efficacy of<br />\n rivaroxaban compared to standard of care with similar rates of major and clinically<br />\n relevant non-major bleeding. EINSTEIN PE further demonstrated a significant<br />\n reduction of major bleeding events in patients treated with rivaroxaban compared to<br />\n standard of care. EINSTEIN-EXT demonstrated that continued treatment with<br />\n rivaroxaban after 6 or 12 months initial treatment is superior in preventing<br />\n recurrences, as compared with placebo, and has an acceptable risk of bleeding.<br />\n At the time of writing, rivaroxaban is approved by the EMA, the FDA, Singapore,<br />\n Malaysia, Indonesia, Philippines, Taiwan, Korea and Mexico, Brazil, Argentina,<br />\n Chile, Colombia, Peru, Ecuador, Uruguay, and several other countries in Latin<br />\n America as well as in the EMEA region Saudi Arabia, Egypt, Middle Africa, UAE,<br />\n Kuwait, Qatar, Turkey, Jordan, Lebanon, Russia, Kazakhstan and Algeria for the<br />\n treatment of acute DVT, PE and recurrent VTE following DVT or PE in adults. The<br />\n approved dose is 15mg bid for the first 21 days followed by 20mg od for the<br />\n continuing treatment period. Further dosing information are listed in detail in the<br />\n Summary of Product Characteristics (SmPC). In the European Union and other<br />\n countries, rivaroxaban is the first agent that allows treatment of thrombotic events<br />\n with a single drug approach. Treatment with rivaroxaban can be already initiated at<br />\n diagnosis and does not require intravenous/subcutaneous heparin or VKA anymore.<br />\n If the decision is made to switch treatment from rivaroxaban to current standard of<br />\n care, adequate anticoagulation has to be ensured. In patients converting from rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥2.0.<br />\n Patients converting from rivaroxaban to parenteral anticoagulation should receive<br />\n the parenteral anticoagulant at the time originally scheduled for the intake of<br />\n rivaroxaban.<br />\n Bayer conducts the XALIA LEA study to yield complementary post-authorization<br />\n information in rivaroxaban or standard therapy patients under real-life conditions.</p>\n
      • study_title<p>\n XALIA LEA- Xarelto® for Long-term and<br />\n Initial Anticoagulation in Venous<br />\n Thromboembolism (VTE) in Latin America,<br />\n EMEA and Asia</p>\n
      • laymans_summary(null)
      • short_titleRivaroxaban for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
      • protocol_noECCT/14/12/01
      • version_noXA1402 (Impact No. 17237), Protocol Version 1.0
      • date_of_protocol18-02-2014
      • study_drugBay 59-7939, Rivaroxaban, Xarelto®
      • disease_conditionTreatment of deep vein thrombosis (DVT)
      • 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_nameRivaroxaban
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressselina.musalia@bayer.com
      • 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_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_applicantJohn Mwangi (john.mwangi@bayer.com)
      • declaration_date103-12-2014
      • declaration_principal_investigatorDr. Anne Njambi,Dr Allibhoy Ali, Dr Charles Kariuki,Dr Martin Wanyoike
      • declaration_date203-12-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n ï‚· Female or male patients, who are at >=18 years<br />\n ï‚· Diagnosis of acute DVT and/or PE, objectively confirmed<br />\n ï‚· Indication for anticoagulation therapy for at least 12 weeks<br />\n ï‚· Willing to participate in this study and available for follow-up</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria must be read in conjunction with the local product information.<br />\n Patients who are found to receive treatment contrary to the local product information<br />\n will not be excluded. Depending on the number of patients receiving rivaroxaban<br />\n contrary to the local product information these patients can be analyzed in a separate<br />\n analysis. Further details will be described in the SAP.<br />\n  </p>\n
      • primary_end_points<p>\n Major bleedings defined as overt bleeding associated with:<br />\n  A fall in hemoglobin of ≥2 g/dL, or<br />\n  A transfusion of ≥2 units of packed red blood cells or whole blood, or<br />\n  Occurrence at a critical site: intracranial, intra-spinal, intraocular,<br />\n pericardial, intra-articular, intra-muscular with compartment syndrome,<br />\n retroperitoneal<br />\n  Death<br />\n o Symptomatic recurrent venous thromboembolic events confirmed by objective<br />\n diagnostic tools<br />\n o All-cause mortality<br />\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Prime Care Heart Clinic. Number of Staff:3</p>\n<p>\n Dr Silversteins Clinic.Number of Staff: 2</p>\n<p>\n Nairobi Cardiovascular Clinic.Number of Staff: 3</p>\n<p>\n Agakhan Kisumu:Number of staff 1</p>\n<p>\n Please refer to CVs attached.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n A similar study the Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study was conducted to evaluate the efficacy and safety of rivaroxaban compared to the VKA warfarin in the prevention of thromboembolic events in subjects with non-valvular AF was conducted in the host country.</p>\n<p>\n The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT and/or PE in routine clinical practice use in Latin America, Eastern Europe, Middle East and Africa.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration12 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_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states10
      • number_of_sitesMultiple
      • multi_country_listLatin America, Eastern Europe,Middle East and Asia
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide2500
      • 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_elderlyYes
      • 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_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDavid Kuria Kamau
      • investigator1_middle_nameKuria
      • investigator1_family_nameKamau
      • investigator1_qualificationMBChB , M.Med
      • investigator1_professional_addressPrime care heart clinic ,Nairobi Hospital, Nairobi Kenya
      • investigator1_telephone+254 722 578 308
      • investigator1_emailkuriakamau@gmail.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date27-01-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-12-2014
      • 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)
      • modified2017-05-05 10:34:58
      • created2014-11-06 14:24:03
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id242
        • application_id350
        • given_nameAnne Njeri Mugera
        • middle_nameNjambi
        • family_nameMugera
        • qualificationMBChB, Mmed
        • professional_addressDr. Silversteins Clinic, Nairobi Hospital ,Nairobi Kenya.
        • telephone+254 722 747 695
        • emaildrannemugeraknh@gmail.com
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
      • 1(array)
        • id243
        • application_id350
        • given_nameDr. Martin N Wanyoike
        • middle_nameNjoroge
        • family_nameWanyoike
        • qualificationMBChB,M.Med ,CTM
        • professional_addressPrime Care Heart Clinic , Nairobi Hospital, Nairobi Kenya
        • telephone+254 720 921 553
        • emailprimecareheartclinic@gmail.com
        • created2014-11-06 15:07:54
        • modified2014-12-04 10:39:27
      • 2(array)
        • id244
        • application_id350
        • given_nameCharles Muthui Kariuki
        • middle_nameMuthui
        • family_nameKariuki
        • qualificationMBChB,MRCP,M.Med,FRCP
        • professional_addressNairobi Cardiovascular Clinic, NairobI Hospital ,Nairobi ,Kenya
        • telephone+254 733 370 057
        • emailckthreesk@gmail.com
        • created2014-11-06 15:13:05
        • modified2014-12-04 10:39:27
      • 3(array)
        • id245
        • application_id350
        • given_nameFEROZ ALI
        • middle_name
        • family_nameAllibhoy
        • qualificationMBBS
        • professional_addressP.O Box 530 Kisumu
        • telephone(057)2020005 / 2023300
        • emaildr.f.allibhoy@live.com
        • created2014-11-10 16:11:56
        • modified2014-12-04 10:39:27
    • SiteDetail(array)
      • 0(array)
        • id293
        • application_id350
        • county_id47
        • site_namePrimecare Heart Clinic
        • physical_addressPrime care Heart clinic Nairobi Hospital , Nairobi , Kenya
        • contact_detailsP.O.BOX 19552-00202 NAIROBI
        • contact_personDr. Martin Wanyoike
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id294
        • application_id350
        • county_id47
        • site_nameDr. Silversteins Clinic
        • physical_addressDr.Silversteins Clinic , Nairobi Hospita Nairobi Kenya.
        • contact_details+254 722 747 695
        • contact_personDr.Anne Mugera
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 15:35:33
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id295
        • application_id350
        • county_id47
        • site_nameNairobi Cardiovascular Clinic
        • physical_addressNairobi Cardiovascular Clinic,Nairobi Hospital, Nairobi Kenya
        • contact_details+254 733 370 057
        • contact_personDr.Charles Kariuki
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 15:35:33
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id296
        • application_id350
        • county_id42
        • site_nameAgah Khan Kisumu
        • physical_addressKisumu
        • contact_detailsP.O Box 530 Kisumu
        • contact_personDr Allibhoy Feroz Ali
        • site_capacity(null)
        • misc(null)
        • created2014-11-10 16:13:39
        • modified2014-12-04 10:39:28
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id185
        • application_id350
        • sponsorBayer HealthCare AG, Germany
        • sponsor_type(null)
        • contact_personChristopher Maina Wairegi
        • address30321-00100 Thika Road/Outering road , Ruaraka
        • telephone_number+254 20 8600000
        • fax_number+254 20 8600010
        • cell_number+254 700 390 311
        • email_addresschristopher.wairegi@bayer.com
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
  • 4(array)
    • Application(array)
      • id376
      • user_id255
      • trial_status_id6
      • abstract_of_study<p>\n <strong><u> SYNOPSIS</u></strong><br />\n Study title<br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n Trial Design Immediate vs delayed study<br />\n <u>Study Population</u><br />\n HIV-1/2 negative, females at low risk of HIV aged 18-50 years of<br />\n age.<br />\n Planned Sample Size 44<br />\n Planned Trial Period 13 months after recruitment<br />\n Primary Outcome To measure cervical mucosal immune activation after VZVvaccination<br />\n in the context of VZV-effector responses.<br />\n <u>Secondary Objective</u><br />\n To measure the effector VZV-specific CD8+ T cells at the rectal<br />\n mucosa after VZV vaccination;<br />\n To compare the immune activation observed in mucosal tissues<br />\n and in blood.<br />\n <u>Primary Endpoint</u><br />\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.<br />\n <u>Secondary endpoints</u><br />\n An increase in the percentage of VZV-specific CD8+T cells at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. This increase must be significantly different<br />\n from the change observed in the same period for the delayed group<br />\n in order to be considered associated to vaccination.<br />\n To compare the expression of co-receptors and activation markers<br />\n such as CCR5, α4β7, CD38, CD69 and HLA-DR in blood and<br />\n cervical CD4+T cells at 3 months after immunization with<br />\n varicella vaccine.<br />\n Investigational<br />\n Medicinal Product<br />\n Zostavax®<br />\n KAVI-VZV-001 Version 2.0 (01 September 2014) Page 9 of 49<br />\n Dose Zostavax® >19,400 PFU (Z)<br />\n Route Subcutaneous needle injection<br />\n <u>Study Design</u><br />\n Vaccination Period<br />\n Group No. Wk 0 Wk 12<br />\n Immediate 22 Z -<br />\n Delayed 22 - Z<br />\n <u>Follow-Up Duration</u><br />\n After the vaccination with Zostavax®, the delayed groups will be<br />\n followed-up for 9 months and the immediate groups for 12<br />\n months.<br />\n Trial Sponsor University of Toronto, Canada</p>\n
      • study_title<p style=\"text-align: justify;\">\n <br />\n <u><strong>Study title</strong></u><br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n  </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/01/02
      • version_noVersion No: 2.0 (01 September 2014)
      • date_of_protocol01-09-2014
      • study_drugVaricella Zoster Virus vaccine Zostavax® (Merck)
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameZostavax®
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressEmutisya@kaviuon.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_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_applicantKAVI-Institute of Clinical Research (KAVI-ICR) University of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya
      • declaration_date115-01-2015
      • declaration_principal_investigatorProfessor Walter Jaoko, MB, ChB, MTropMed, PhD, Site Principal Investigator
      • declaration_date215-01-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. Healthy females, as assessed by a medical history, physical examination and<br />\n laboratory tests, with no chronic medical condition;<br />\n 2. Aged at least 18 years on the day of screening and no greater than 50 years on the day<br />\n of the first vaccination.<br />\n 3. VZV-seropositive, as assessed by the VIDAS assay.4. Ability to comply with the study requirements and available for follow-up for the<br />\n planned duration of the study.<br />\n 5. In the opinion of the Principal Investigator or designee, the volunteer has understood<br />\n the information provided and signed the consent document.<br />\n 6. Willing to undergo HIV testing, HIV counselling and receive HIV test results.<br />\n 7. For women with potential to become pregnant, willing to use effective contraception<br />\n or barrier methods to avoid pregnancy during the study (spermicides or chemicals are<br />\n not allowed).<br />\n  </p>\n
      • principal_exclusion_criteria<p>\n Any relevant abnormality on history or examination including history of tuberculosis,<br />\n immunodeficiency or autoimmune disease, or use of systemic corticosteroids,<br />\n immunosuppressive, antiviral, anticancer or other medication that, in the opinion of the<br />\n Principal Investigator or designee, is clinically significant. (Note: use of inhaled steroids for<br />\n asthma or use of topical steroids for localized skin conditions will not exclude a volunteer<br />\n from participation) and/or:<br />\n 1. A high risk for HIV-acquisition defined by the experience of any of the follow<br />\n situations:<br />\n a) Had unprotected vaginal or anal sex with a known HIV-1-infected person, a<br />\n person known to be at high risk for HIV or a casual partner (i.e., no continuing,<br />\n established relationship) within the previous 6 months;<br />\n b) Engaged in sex work for money or drugs within the previous 6 months;<br />\n c) Used injection drugs;<br />\n d) Abuse of illicit or prescribed drugs, including alcohol;<br />\n e) Acquired one of the following sexually transmitted infection: chlamydia,<br />\n gonorrhoea and syphilis in the last 12 months;<br />\n f) More than 1 sexual partner within the last 6 months;<br />\n g) New sexual partner within the last 3 months.<br />\n 2. Persistent or recurrent bacterial vaginosis or vaginal candidiasis unresponsive to<br />\n therapy (2 consecutive attempts by study team).<br />\n 3. Confirmed HIV-1 or HIV-2 infection.<br />\n 4. Any clinically significant acute or chronic medical condition that is considered<br />\n progressive or, in the opinion of the Principal Investigator or designee, would make<br />\n the volunteer unsuitable for the study (active or underlying diabetes, gastrointestinal,<br />\n cardiovascular, malignancy, neurological, psychiatric, metabolic, renal, hepatic,<br />\n respiratory, auto-immune diseases, psoriasis, primary and acquired immunodeficiency<br />\n KAVI-VZV-</p>\n<p>\n status and rectal problems).<br />\n 5. Any of the following abnormal laboratory parameters except that one abnormal<br />\n laboratory test may be repeated once if thought to be due to a temporary condition:<br />\n Haematology<br />\n a) Haemoglobin < 9.0 g/dl<br />\n b) Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /l, ≥ 550 /l)<br />\n Coagulation<br />\n - INR <1.0 or >1.5<br />\n 6. Evidence of coagulopathy demonstrated by a reduced level of platelets or a history of<br />\n 3 or more episodes of uncontrolled bleeding from their mouth, nose or other mucous<br />\n membrane (marked by excessive bleeding of more than 30 min).<br />\n 7. A positive pregnancy test or breast-feeding at screening; for the participants with<br />\n reproductive potential, unwilling to use an effective method of preventing pregnancy<br />\n during the study.<br />\n 8. Receipt of vaccine within the previous 2 months or planned receipt at any time until 6<br />\n months after vaccination with Zostavax®.<br />\n 9. Receipt of blood transfusion or blood products within the previous 6 months.<br />\n 10. Participation in another clinical trial currently or within the previous 3 months.<br />\n 11. History of severe or very severe local or systemic reactogenicity events after<br />\n vaccination, or history of severe or very severe allergic reactions.<br />\n 12. History of toxic shock syndrome.<br />\n 13. Confirmed diagnosis of acute or chronic hepatitis B virus infection (spontaneous<br />\n clearance leading to natural immunity, indicated by antibodies to core + antigens, is<br />\n not an exclusion criterion); confirmed diagnosis of hepatitis C virus infection.<br />\n 14. Immunosuppressive medications 30 days before or during the study period.<br />\n 15. History of anaphylactic/anaphylactoid reaction to neomycin (each dose of<br />\n reconstituted vaccine contains trace quantities of neomycin).<br />\n 16. Major psychiatric illness including any history of schizophrenia or severe psychosis,<br />\n bipolar disorder, suicidal attempt or ideation in the previous 3 years.<br />\n 17. Contra-indication for undergoing a biopsy due to bleeding diathesis, haemorrhoids,<br />\n mucosal infection at the biopsy site, medication that interfere with clotting (e.g.<br />\n warfarin or heparin) – both clinical and laboratory.<br />\n 18. Any other reason as determined by the Principal Investigator</p>\n
      • primary_end_points<p>\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifycharacterization of mucosal immune response.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n Name</p>\n </td>\n <td>\n <p>\n Designation</p>\n </td>\n <td>\n <p>\n Qualifications</p>\n </td>\n <td>\n <p>\n Years in research</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Omu Anzala</p>\n </td>\n <td>\n <p>\n Co-Investigator</p>\n </td>\n <td>\n <p>\n MBChB, diploma epidemiology, PhD medical microbiology and infectious disease, post doc fellow molecular immunology group institute of molecular medicine oxford university</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Walter Jaoko</p>\n </td>\n <td>\n <p>\n Principal Investigator</p>\n </td>\n <td>\n <p>\n MBChB, MSc tropical medicine, diploma research methodology, PhD medical mirobiology</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Kirana Bhatt</p>\n </td>\n <td>\n <p>\n Consultant Physician</p>\n </td>\n <td>\n <p>\n MBChB, MMed internal medicine, MSc clinical tropical medicine, PhD</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gina Ouattara</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB</p>\n </td>\n <td>\n <p>\n 5.5</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gaudensia Mutua</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB, MPH</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Emmanuel Museve</p>\n </td>\n <td>\n <p>\n Study clinician</p>\n </td>\n <td>\n <p>\n Diploma clinical medicine and surgery</p>\n </td>\n <td>\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jacquelyn Nyange</p>\n </td>\n <td>\n <p>\n Study coordinator - regulatory</p>\n </td>\n <td>\n <p>\n KRN, BA psychology, MSc clinical psychology</p>\n </td>\n <td>\n <p>\n 11</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Elizabeth Mutisya</p>\n </td>\n <td>\n <p>\n Study coordinator – clinic level</p>\n </td>\n <td>\n <p>\n KRCHN, BA psychology and sociology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Hilda Ogutu</p>\n </td>\n <td>\n <p>\n Senior study nurse</p>\n </td>\n <td>\n <p>\n KRM, KRCHN, BScN</p>\n </td>\n <td>\n <p>\n 13</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Ndambuki</p>\n </td>\n <td>\n <p>\n Study nurse</p>\n </td>\n <td>\n <p>\n KRCHN, HND counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Roselyne Malogo</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n KRCHN, certificate in conflict resolution, BA community development</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Mahira</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n ECN, diploma in counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Bashir Farah</p>\n </td>\n <td>\n <p>\n Laboratory manager</p>\n </td>\n <td>\n <p>\n HND virology, MSc Virology</p>\n </td>\n <td>\n <p>\n 18</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jackton Indagasi</p>\n </td>\n <td>\n <p>\n Laboratory quality assurance manager</p>\n </td>\n <td>\n <p>\n PGD infectious disease, MSc infectious disease</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Robert Langat</p>\n </td>\n <td>\n <p>\n Laboratory and site Safety officer</p>\n </td>\n <td>\n <p>\n BSc medical laboratory technology</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Simon Ogolla</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n HND microbiology</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Irene Mwangi</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n Diploma laboratory technology, BSc laboratory technology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Ruth Chirchir</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n BSc biological sciences</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Moses Muriuki</p>\n </td>\n <td>\n <p>\n Data/IT Manager</p>\n </td>\n <td>\n <p>\n BSc software engineering</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Laura Lusike</p>\n </td>\n <td>\n <p>\n Data assistant</p>\n </td>\n <td>\n <p>\n BA home economics</p>\n </td>\n <td>\n <p>\n 14</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Other staff:</p>\n <p>\n Administrative, Finance and support staff</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n Site facilities:<br />\n - Reception<br />\n - Waiting room for volunteers<br />\n - Counseling rooms - 2<br />\n - Patient examination rooms – 3<br />\n - Study records filing room – limited access using swipe card<br />\n - Laboratories – swipe access<br />\n o safety laboratory<br />\n o immunology laboratory<br />\n - Data room – limited access with swipe card<br />\n o Pre – archive room – swipe card access<br />\n o Data entry computers – 4<br />\n o Online and offline data entry capabilities<br />\n o Data faxing<br />\n o Internet – upload and download bandwidth of 1MB/second and backup modems from mobile service providers<br />\n o Backup UPS of 4 – 6 hours and backup generator<br />\n - Kitchenette – for staff and volunteer refreshments<br />\n - Meeting room<br />\n Emergency facilities:<br />\n - One of the patient examination rooms is equipped as an emergency room with oxygen tank and mask, suction pump machine with suction tubes, defibrillator, nebulizer, laryngoscope, endotracheal tubes, airway, adult ambu bag and mask, giving sets.<br />\n - Emergency stretcher<br />\n - Emergency drugs in stock –<br />\n o Parenteral - hydrocortisone, adrenaline, paracetamol, hyosine, atropine, lidocaine, lignocaine, aminophylline, sodium bicarbonate, metoclopramide, diazepam, chlorpheniramine, calcium gluconate,<br />\n o Salbutamol nebulizer solution<br />\n o IV fluids – 5% dextrose, 50% dextrose, normal saline<br />\n o Post exposure prophylaxis – combivir and kaletra<br />\n - Patients can then be transferred to Kenyatta National Hospital emergency department or admitted to the wards for further care.</p>\n
      • other_details_explanation<p>\n In this trial we ai to investigate the potentail of using varicella-zoster virus (VZV) as a vector for an hiv-vaccine by first characterising the mucosal immune response induced by VZV vaccination. As we intend to conduct the future VZV-HIV phase 1 clinical trial ( with VZV carrying HIV genes) in kenya it is important that the study that sets the basis for this future be also conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Toronto research ethics committee, !st Dec 2014.</p>\n
      • other_details_regulatory_approved<p>\n KNH/UON Ethics research committee.</p>\n<p>\n Approval date:23rd oct 2014.</p>\n<p>\n Sites: KAVI-ICR, Nairobi Kenya.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration13 months after enrollment.
      • 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_areaKAVI-INSTITUTE OF CLINICAL RESEARCH (KAVI-ICR)
      • single_site_physical_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya.
      • single_site_contact_personProfessor Walter Jaoko,
      • single_site_telephone+254-2-2717694/+254727555254
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listKENYA\nCANADA
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide44
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • 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_nameProf Walter Jaoko
      • investigator1_middle_name
      • investigator1_family_name Jaoko
      • investigator1_qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
      • investigator1_professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
      • investigator1_telephone+254-2-2717694/+254727555254
      • investigator1_emailwjaoko@kaviuon.org
      • organisations_transferred_Yes
      • number_participants44
      • notification<p>\n none.</p>\n
      • approval_date10-03-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-01-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-04-26 16:23:36
      • created2015-01-15 09:38:39
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id256
        • application_id376
        • given_nameProf Walter Jaoko
        • middle_name
        • family_nameJaoko
        • qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
        • professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
        • telephone+254-2-2717694/+254727555254
        • emailwjaoko@kaviuon.org
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
    • SiteDetail(array)
      • 0(array)
        • id307
        • application_id376
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id194
        • application_id376
        • sponsorUniversity of Toronto
        • sponsor_type(null)
        • contact_personDr. Kelly S. MacDonald, MD, FRCPC, Chief Investigator
        • addressDepartment of Medicine and Immunology University of Toronto 1 King’s College Circle Medical Sciences Building, Room 6360 Toronto ON, M5S 1A8 Canada.
        • telephone_number(416) 946-3733
        • fax_number(416) 978-8765
        • cell_number(416) 946-3733
        • email_addresskelly.macdonald@utoronto.ca
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_use1
• $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