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    • Application(array)
      • id1075
      • user_id294
      • trial_status_id1
      • abstract_of_study<p>\n Current diarrhea management strategies in low- and middle-income countries (oral rehydration solution, ReSoMal and zinc) focus primarily on the management of dehydration and micronutrient replacement and appear to have negligible impact in preventing future diarrheal episodes or improving nutritional outcomes. Lactoferrin and lysozyme are milk-derived nutritional supplements that may reduce the risk of diarrheal episodes and accelerate nutritional recovery by treating or preventing underlying enteric infections and/or improving enteric function. Children with moderate or severe wasting are at particularly high-risk of death, diarrhea recurrence, and nutritional deterioration following a diarrheal episode.<a href=\"#_ENREF_1\" title=\"Black, 2013 #454\">^1-</a>^{5 1-5 1-5 1-5} This factorial, double-blind, placebo-controlled, randomized trial aims to determine the efficacy of lactoferrin and lysozyme supplementation in decreasing diarrhea incidence and improving nutritional recovery in children convalescing from diarrhea and wasting. We will explore whether these interventions improve outcomes by reducing enteric pathogens, improving enteric function and/or increasing hemoglobin concentrations in these children. This study aims to enroll 600 Kenyan children aged 6-24 months from facilities in Western Kenya with a mid-upper arm circumference <12.5cm returning home from an outpatient visit or inpatient hospital stay for diarrhea. Eligible children will also plan to remain in study area > 6 months, will not be enrolled in another study, are no longer exclusively breastfeeding, and have not had 2 or more blood transfusions in the past 12 months. Enrolled children will be randomized to 16-weeks of lactoferrin, lysozyme, a combination of the two, or placebo and be followed up for 24 weeks total, with bi-weekly home visits by community health workers and clinic visits at 4, 10, 16, and 24 weeks. Results of this study will inform management strategies for children with moderate/severe wasting at high risk for mortality, morbidity, and nutritional deterioration following diarrhea.</p>\n
      • study_title<p>\n Lactoferrin and Lysozyme supplementation for long-term diarrhea sequelae</p>\n
      • laymans_summary<p>\n Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or “ORS”). This study will test whether nutritional supplements made from milk (lactoferrin or lysozyme) or a combination of the two (lactoferrin and lysozyme) will prevent children from having repeated diarrhea episodes and help improve their nutrition by improving their stomach health or preventing new disease during this 6-month period. The study is taking place at 7 hospitals in Western Kenya. Six hundred participants will be enrolled if they provide informed consent to participate, are aged 6-24 months, were hospitalized with diarrhea and malnutrition and have been managed by the facility nutritionists and ready to return home. Participation in the study will entail providing information on the child’s health history, collection of stool samples, blood, and potentially urine. The caregiver will be provided sachets of the investigational product to take home and mix daily with their child’s porridge or other complimentary food, and asked to return to the clinic 4 times in the subsequent 6 months, and also consent to having a community health worker visit their home every two weeks for a follow up visit. The risks to the participant and their caregiver are minimal. The information gained in this study will help us create new treatments and develop new strategies to treat sick children to prevent death and illness.</p>\n
      • short_titleLactolize Study
      • protocol_noECCT/21/10/05
      • version_no1.0
      • date_of_protocol24-06-2021
      • study_drugLactoferrin and lysozyme
      • disease_conditionDiarrhea
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssingabo2008@gmail.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_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • 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_plan1
      • applicant_contractual_agreement1
      • declaration_applicant0725234844
      • declaration_date126-10-2021
      • declaration_principal_investigatorBenson Singa (Principal Investigator)
      • declaration_date226-10-2021
      • placebo_presentYes
      • study_objectives<ol>\n <li align=\"justify\">\n To determine whether a 16-week course of lactoferrin, lysozyme or a combination of both shortens time to WHO-defined recovery from wasting (MUAC ≥12.5cm) and reduces the incidence of medically-attended diarrhea during the subsequent 6-months following presentation to a health facility with diarrhea among children with moderate/severe childhood wasting (MUAC <12.5 cm at the time of screening).</li>\n <li align=\"justify\">\n To explore whether a 16-week course of lactoferrin, lysozyme or combination therapy improves secondary clinical, nutritional, enteric pathogen, and enteric function outcomes.</li>\n <li align=\"justify\">\n To evaluate acceptability, adherence and cost-effectiveness of lactoferrin and/or lysozyme in Kenya.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<ol>\n <li>\n Child aged 6-24 months</li>\n <li>\n Child seen as an inpatient or outpatient for diarrhea who is ready to return home, with a MUAC <12.5 cm at the time of screening</li>\n <li>\n Child whose caregiver consents to study participation</li>\n <li>\n Caregiver and child plan to remain in study area > 6 months</li>\n <li>\n Child is not enrolled in another study</li>\n <li>\n Child is no longer exclusively breastfeeding.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li style=\"margin-left: 6.8pt;\">\n Children younger than 6 months or older than 24 months</li>\n <li style=\"margin-left: 6.8pt;\">\n Accompanying caregiver does not provide consent to study participation</li>\n <li style=\"margin-left: 6.8pt;\">\n Child has history of 2 or more blood transfusions in the past 12 months</li>\n <li style=\"margin-left: 6.8pt;\">\n Caregiver reports the child will not stay within the study area for the next 6 months or greater</li>\n <li style=\"margin-left: 6.8pt;\">\n Enrollment in another study</li>\n <li style=\"margin-left: 6.8pt;\">\n Child is exclusively breastfeeding at the time of enrollment</li>\n <li style=\"margin-left: 6.8pt;\">\n Child is not ready to return home (is not yet discharged)</li>\n <li style=\"margin-left: 6.8pt;\">\n Child was discharged against medical advice, or child has a history of congenital defect or syndrome that prevents age-appropriate feeding (e.g. cleft palate)</li>\n</ol>\n
      • primary_end_points<ol>\n <li style=\"margin-left: 6.8pt;\">\n Incidence of medically-attended diarrhea</li>\n <li style=\"margin-left: 6.8pt;\">\n Time to nutritional recovery</li>\n</ol>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • 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_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p align=\"center\">\n <strong>Awendo Sub-County Hospital</strong></p>\n<p align=\"center\">\n <strong>P.O Box 1-40405 Awendo</strong></p>\n<p>\n <strong>General Facility Description</strong></p>\n<p>\n Awendo Sub-County Hospital is located within Awendo Town, Awendo Sub-County, in Migori County and is headed by a Medical Superintendent.</p>\n<p>\n The hospital is a Level 4 government hospital which is a referral point for primary health units. It has the resources to provide comprehensive medical and some surgical services. It is a 30-bed capacity hospital including 7 pediatric beds. The hospital offers outpatient, inpatient and maternal child health services (MCH) that includes immunization services and treatment of children under five years.</p>\n<p>\n Based on the 2019/2020 Facility Annual Work Plan and Kenya MOH Data Reporting Tools (Child Welfare Clinic Register and Outpatient Register, the hospital has under five catchment population of 4553 of which 1366 children fall within 6 - 24 months. Approximately 30 children under 2 years present to the hospital with diarrhea per month while 5 present with co-morbid diarrhea and wasting per month.</p>\n<p>\n The hospital was selected because Kenya Medical Research Institute/University of Washington (KEMRI/UW) implemented a large-scale clinical trial in the facility and the study team developed strong partnerships with the hospital leadership and clinical staff.</p>\n<p>\n <strong>Clinical Research Facility:</strong></p>\n<p>\n KEMRI/UW has a dedicated study office (refurbished 40ft container) located within the hospital near the MCH clinic and pediatric ward. It has spacious rooms for consenting, clinical procedures, data entry, data storage, staff room, study medication administration and storage as well as laboratory procedures.</p>\n<p>\n <strong>Study Staff:</strong></p>\n<p>\n The following dedicated study staff will be stationed at the site:</p>\n<p style=\"margin-left:36pt;\">\n - 1 Clinical Officer who is also the site supervisor</p>\n<p style=\"margin-left:36pt;\">\n - 1 Medical Laboratory Technologist</p>\n<p style=\"margin-left:36pt;\">\n - 2 Community Health Workers</p>\n<p>\n <strong>Study Equipment</strong></p>\n<p>\n The study site has anthropometric measurement equipment (weighing scales, length boards and MUAC tapes), equipment required to process and store study samples (-80ºC freezer, refrigerator, pipettes, and vortex machines) and refrigerator for study product storage.</p>\n<p>\n  </p>\n<p align=\"center\">\n <strong>Homa Bay County Referral Hospital</strong></p>\n<p align=\"center\">\n <strong>P.O Box 52-40300 Homa Bay</strong></p>\n<p>\n <strong>General Facility Description</strong></p>\n<p>\n Homa Bay County Referral Hospital is located within Homabay Town, Homa Bay Township Sub-County in Homa Bay County and is headed by a Chief Executive Officer.  </p>\n<p>\n The facility is a Level 5 government hospital which is a referral point for lower level secondary and primary health units. It has the resources to provide comprehensive medical and surgical services. It is a 300-bed capacity hospital including 30 pediatric beds. The hospital offers outpatient, inpatient and maternal child health services (MCH) that includes immunization services and treatment of children under five years.</p>\n<p>\n Based on the 2019/2020 Facility Annual Work Plan and Kenya MOH Data Reporting Tools (Child Welfare Clinic Register and Outpatient Register), the hospital has under five catchment population of 6602 of which 1981 children fall within 6 - 24 months. Approximately 60 children under 2 years present to the hospital with diarrhea per month while 9 present with co-morbid diarrhea and wasting per month.</p>\n<p>\n The hospital was selected because Kenya Medical Research Institute/University of Washington (KEMRI/UW) has implemented large-scale clinical trials and research over the years and the study team has since developed strong partnerships with the leadership and clinical staff at the facility.</p>\n<p>\n <strong>Clinical research facility:</strong></p>\n<p>\n KEMRI/UW has dedicated study offices located within the hospital near the MCH clinic and right in the pediatric ward. It has spacious rooms for consenting, clinical procedures, data entry, data storage, staff room, study medication administration and storage as well as laboratory procedures.</p>\n<p>\n <strong>Research Staff:</strong></p>\n<p>\n The following dedicated study staff will be stationed at the site:</p>\n<p style=\"margin-left:36pt;\">\n - 1 Clinical Officer who is also the site supervisor</p>\n<p style=\"margin-left:36pt;\">\n - 1 Medical Laboratory Technologist</p>\n<p style=\"margin-left:36pt;\">\n - 2 Community Health Workers</p>\n<p>\n <strong>Study Equipment</strong></p>\n<p>\n The study site has anthropometric measurement equipment (weighing scales, length boards and MUAC tapes), equipment required to process and store study samples (-80ºC freezer, refrigerator, pipettes, and vortex machines) and refrigerator for study product storage.</p>\n<p>\n  </p>\n<p align=\"center\">\n <strong>Isebania Sub-County Hospital</strong></p>\n<p align=\"center\">\n <strong>P.O Box 25-40414 Isebania</strong></p>\n<p>\n <strong>General Facility Description</strong></p>\n<p>\n Isebania Sub-County Hospital is located within Isebania Town, Kuria East sub-county, in Migori County and is headed by a Medical Superintendent.</p>\n<p>\n The facility is a Level 4 government hospital which is a referral point for primary health units. It has the resources to provide comprehensive medical and surgical services. It is a 30-bed capacity hospital including 8 pediatric beds. The hospital offers outpatient, inpatient and maternal child health services (MCH) that includes immunization services and treatment of children under five years.</p>\n<p>\n Based on the 2019/2020 Facility Annual Work Plan and Kenya MOH Data Reporting Tools (Child Welfare Clinic Register and Outpatient Register, the hospital has under five catchment population of 5907 of which 1773 children fall within 6 - 24 months. Approximately 45 children under 2 years present to the hospital with diarrhea per month while 7 present with co-morbid diarrhea and wasting per month.</p>\n<p>\n The hospital was selected because Kenya Medical Research Institute/University of Washington (KEMRI/UW) implemented a large-scale clinical trial in the facility and the study team developed strong partnerships with the hospital leadership and clinical staff.</p>\n<p>\n <strong>Clinical Research Facility:</strong></p>\n<p>\n KEMRI/UW has a dedicated study office (refurbished 20ft container) located within the hospital near the MCH clinic and pediatric ward. It has spacious rooms for consenting, clinical procedures, data entry, data storage, staff room, study medication administration and storage as well as laboratory procedures.</p>\n<p>\n <strong>Study Staff:</strong></p>\n<p>\n The following dedicated study staff will be stationed at the site:</p>\n<p style=\"margin-left:36pt;\">\n - 1 Clinical Officer who is also the site supervisor</p>\n<p style=\"margin-left:36pt;\">\n - 1 Medical Laboratory Technologist</p>\n<p style=\"margin-left:36pt;\">\n - 2 Community Health Workers</p>\n<p>\n <strong>Study Equipment</strong></p>\n<p>\n The study site has anthropometric measurement equipment (weighing scales, length boards and MUAC tapes), equipment required to process and store study samples (-80ºC freezer, refrigerator, pipettes, and vortex machines) and refrigerator for study product storage.</p>\n<p>\n  </p>\n<p align=\"center\">\n <strong>Kendu Adventist Hospital</strong></p>\n<p align=\"center\">\n <strong>P.O Box 20-40301 Kendu Bay</strong></p>\n<p>\n <strong>General Facility Description</strong></p>\n<p>\n Kendu Adventist Hospital is located in Karachuonyo sub-county, Homa Bay county approximately 5 Km from Kendu Bay town and is headed by a Medical Superintendent.</p>\n<p>\n The facility is a Level 4 mission hospital and has the resources to provide comprehensive medical and surgical services. It is a 164-bed capacity hospital including 20 pediatric beds. The hospital offers outpatient, inpatient and maternal child health services (MCH) that includes immunization services and treatment of children under five years.</p>\n<p>\n Based on the 2019/2020 Facility Annual Work Plan and Data Reporting Tools (Child Welfare Clinic Register and Outpatient Register, the hospital has a catchment under five population of 2607 of which 1200 children fall within 6 - 24 months. Approximately 40 children under 2 years present to the hospital with diarrhea per month while 6 present present with co-morbid diarrhea and wasting per month.</p>\n<p>\n The hospital was selected because Kenya Medical Research Institute/University of Washington (KEMRI/UW) implemented a large-scale clinical trial in the facility and the study team developed strong partnerships with the hospital leadership and clinical staff.</p>\n<p>\n <strong>Clinical Research Facility:</strong></p>\n<p>\n Previously, KEMRI/UW had a dedicated study office located close to the MCH clinic and we strongly believe that it will still be available for the Lactolize study. It is spacious enough to allow the study staff to comfortably carry out consenting, clinical procedures, data entry, data storage, staff room, study medication administration and storage as well as laboratory procedures.</p>\n<p>\n <strong>Study Staff:</strong></p>\n<p>\n The following dedicated study staff will be stationed at the site:</p>\n<p style=\"margin-left:36pt;\">\n - 1 Clinical Officer who is also the site supervisor</p>\n<p style=\"margin-left:36pt;\">\n - 1 Medical Laboratory Technologist</p>\n<p style=\"margin-left:36pt;\">\n - 2 Community Health Workers</p>\n<p>\n <strong>Study Equipment</strong></p>\n<p>\n The study site has anthropometric measurement equipment (weighing scales, length boards and MUAC tapes), equipment required to process and store study samples (-80ºC freezer, refrigerator, pipettes, and vortex machines) and refrigerator for study product storage.</p>\n<p>\n  </p>\n<p align=\"center\">\n <strong>Kisii Teaching and Referral Hospital</strong></p>\n<p align=\"center\">\n <strong>P.O Box 92-40200 Kisii</strong></p>\n<p>\n <strong>General Facility Description</strong></p>\n<p>\n Kisii Teaching and Referral Hospital is located within Kisii Town, Kitutu Chache Sub-County in Kisii County and is headed by a Chief Executive Officer.</p>\n<p>\n The hospital is a Level 5 facility which is a referral point for lower level secondary and primary health units. It has the resources to provide specialized care in addition to comprehensive medical and surgical services. It is a 650-bed capacity hospital including 66 pediatric beds. The hospital offers outpatient, inpatient and maternal child health services (MCH) that includes immunization services and treatment of children under five years.</p>\n<p>\n Based on the 2019/2020 Facility Annual Work Plan and Kenya MOH Data Reporting Tools (Child Welfare Clinic Register and Outpatient Register, the hospital has under five catchment population of 9059 of which 2718 children fall within 6 - 24 months. Approximately 70 children under 2 years present to the hospital with diarrhea per month while 11 present with co-morbid diarrhea and wasting per month.</p>\n<p>\n The hospital was selected because Kenya Medical Research Institute/University of Washington (KEMRI/UW) has implemented large-scale clinical trials and research over the years and the study team has since developed strong partnerships with the leadership and clinical staff at the facility.</p>\n<p>\n <strong>Clinical Research Facility:</strong></p>\n<p>\n KEMRI/UW has dedicated study office spaces next to the hospital and also within the pediatric ward. There are spacious rooms for consenting, clinical procedures, data entry, data storage, staff room, study medication administration and storage as well as laboratory procedures.</p>\n<p>\n <strong>Study Staff:</strong></p>\n<p>\n The following dedicated study staff will be stationed at the site:</p>\n<p style=\"margin-left:36pt;\">\n - 1 Clinical Officer who is also the site supervisor</p>\n<p style=\"margin-left:36pt;\">\n - 1 Medical Laboratory Technologist</p>\n<p style=\"margin-left:36pt;\">\n - 2 Community Health Workers</p>\n<p>\n <strong>Study Equipment</strong></p>\n<p>\n The study site has anthropometric measurement equipment (weighing scales, length boards and MUAC tapes), equipment required to process and store study samples (-80ºC freezer, 2-8 refrigerator, pipettes, and vortex machines) and refrigerator for study product storage.</p>\n<p>\n  </p>\n<p align=\"center\">\n <strong>Mbita Sub-County Hospital</strong></p>\n<p align=\"center\">\n <strong>P.O Box 50-40305 Mbita</strong></p>\n<p>\n <strong>General Facility Description</strong></p>\n<p>\n Mbita Sub-County Hospital is located within Mbita Town, Homabay County and is headed by a Medical Superintendent.</p>\n<p>\n The hospital is a Level 4 government hospital which is a referral point for primary health units. It has the resources to provide comprehensive medical and surgical services. It is a 40-bed capacity hospital including 10 pediatric beds. The hospital offers outpatient, inpatient and maternal child health services (MCH) that includes immunization services and treatment of children under five years.</p>\n<p>\n Based on the 2019/2020 Facility Annual Work Plan and Kenya MOH Data Reporting Tools (Child Welfare Clinic Register and Outpatient Register, the hospital has under five catchment population of 5277 of which 1584 children fall within 6 - 24 months. Approximately 43 children under 2 years present to the hospital with diarrhea per month while 7 present with co-morbid diarrhea and wasting per month.</p>\n<p>\n The hospital was selected because Kenya Medical Research Institute/University of Washington (KEMRI/UW) implemented a large-scale clinical trial in the facility and the study team developed strong partnerships with the hospital leadership and clinical staff.</p>\n<p>\n <strong>Clinical Research Facility:</strong></p>\n<p>\n KEMRI/UW has a dedicated study office (refurbished 40ft container) located within the hospital near the MCH clinic and pediatric ward. It has spacious rooms for consenting, clinical procedures, data entry, data storage, staff room, study medication administration and storage as well as laboratory procedures.</p>\n<p>\n <strong>Study Staff:</strong></p>\n<p>\n The following dedicated study staff will be stationed at the site:</p>\n<p style=\"margin-left:36pt;\">\n - 1 Clinical Officer who is also the site supervisor</p>\n<p style=\"margin-left:36pt;\">\n - 1 Medical Laboratory Technologist</p>\n<p style=\"margin-left:36pt;\">\n - 2 Community Health Workers</p>\n<p>\n <strong>Study Equipment</strong></p>\n<p>\n The study site has anthropometric measurement equipment (weighing scales, length boards and MUAC tapes), equipment required to process and store study samples (-80ºC freezer, refrigerator, pipettes, and vortex machines) and refrigerator for study product storage.</p>\n<p>\n  </p>\n<p align=\"center\">\n <strong>Rongo Sub-County Hospital</strong></p>\n<p align=\"center\">\n <strong>P.O Box 258-40404 Rongo</strong></p>\n<p>\n <strong>General Facility Description</strong></p>\n<p>\n Rongo Sub-County Hospital is located within Rongo Town, Migori County and is headed by a Medical Superintendent.</p>\n<p>\n The hospital is a Level 4 government hospital which is a referral point for primary health units. It has the resources to provide comprehensive medical and surgical services. It is a 30-bed capacity hospital including 7 pediatric beds. The hospital offers outpatient, inpatient and maternal child health services (MCH) that includes immunization services and treatment of children under five years.</p>\n<p>\n Based on the 2019/2020 Facility Annual Work Plan and Kenya MOH Data Reporting Tools (Child Welfare Clinic Register and Outpatient Register, the hospital has under five catchment population of 4748 of which 1425 children fall within 6 - 24 months. Approximately 40 children under 2 years present to the hospital with diarrhea per month while 6 present with co-morbid diarrhea and wasting per month.</p>\n<p>\n The hospital was selected because Kenya Medical Research Institute/University of Washington (KEMRI/UW) implemented a large-scale clinical trial in the facility and the study team developed strong partnerships with the hospital leadership and clinical staff.</p>\n<p>\n <strong>Clinical Research Facility:</strong></p>\n<p>\n KEMRI/UW has a dedicated study office (refurbished 40ft container) located within the hospital near the MCH clinic and pediatric ward. It has spacious rooms for consenting, clinical procedures, data entry, data storage, staff room, study medication administration and storage as well as laboratory procedures.</p>\n<p>\n <strong>Study Staff:</strong></p>\n<p>\n The following dedicated study staff will be stationed at the site:</p>\n<p style=\"margin-left:36pt;\">\n - 1 Clinical Officer who is also the site supervisor</p>\n<p style=\"margin-left:36pt;\">\n - 1 Medical Laboratory Technologist</p>\n<p style=\"margin-left:36pt;\">\n - 2 Community Health Workers</p>\n<p>\n <strong>Study Equipment</strong></p>\n<p>\n The study site has anthropometric measurement equipment (weighing scales, length boards and MUAC tapes), equipment required to process and store study samples (-80ºC freezer, refrigerator, pipettes, and vortex machines) and refrigerator for study product storage.</p>\n
      • other_details_explanation<p>\n Sub-Saharan Africa experiences an unacceptably high rate of diarrhea mortality in the under-five population. Additionally, the University of Washington department of Global Health has a long standing collaborative relationship with the Kenya Medical research Institute (KEMRI) and have developed strong professional relationships with the proposed recruitment sites in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n University of Wshington IRB approved this study on 25 February 2021</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationFive (5) years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyFactorial
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • 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_sites7
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment with minimum enrolment of 50 and a maximum of 200 participants per site.
      • total_participants_worldwide600
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • 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_nameJoyce
      • investigator1_middle_nameAkinyi
      • investigator1_family_nameOtieno
      • investigator1_qualificationRegistered Clinical Officer
      • investigator1_professional_address2651-00200 Nairobi
      • investigator1_telephone0780296370
      • investigator1_emailjoyotieno13@gmail.com
      • organisations_transferred_Yes
      • number_participants600
      • notification<p>\n None</p>\n
      • approval_date13-06-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-10-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe responses have been reviewed and considered adequate.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-10-08 08:14:08
      • created2021-10-22 11:42:25
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id740
        • application_id1075
        • given_nameBenson
        • middle_nameOchieng
        • family_nameSinga
        • qualificationMBChB
        • professional_address2651-00200 Nairobi
        • telephone0725234844
        • emailsingabo2008@gmail.com
        • created2021-10-22 13:24:10
        • modified2021-10-27 09:16:06
    • SiteDetail(array)
      • 0(array)
        • id1142
        • application_id1075
        • county_id44
        • site_nameAwendo Sub-County Hospital
        • physical_addressAwendo Town
        • contact_detailsP.O Box 1-40405 Awendo
        • contact_personJoyce Otieno
        • site_capacity(null)
        • misc(null)
        • created2021-10-22 13:24:10
        • modified2021-10-27 09:16:06
        • County(array)
          • id44
          • county_nameMigori
          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
      • 1(array)
        • id1143
        • application_id1075
        • county_id43
        • site_nameHoma Bay County Referral Hospital
        • physical_addressHoma Bay Town
        • contact_detailsP.O Box 52-40300 Homa Bay
        • contact_personJoyce Otieno
        • site_capacity(null)
        • misc(null)
        • created2021-10-22 14:01:38
        • modified2021-10-27 09:16:06
        • County(array)
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          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
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        • application_id1075
        • county_id44
        • site_nameIsebania Sub-County Hospital
        • physical_addressIsebania Town
        • contact_detailsP.O Box 25-40414 Isebania
        • contact_personJoyce Otieno
        • site_capacity(null)
        • misc(null)
        • created2021-10-22 14:05:40
        • modified2021-10-27 09:16:06
        • County(array)
          • id44
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          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
      • 3(array)
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        • site_nameKendu Adventist Hospital
        • physical_addressKendu Bay
        • contact_detailsP.O Box 20-40301 Kendu Bay
        • contact_personJoyce Otieno
        • site_capacity(null)
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        • created2021-10-22 14:07:09
        • modified2021-10-27 09:16:06
        • County(array)
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          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
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        • county_id45
        • site_nameKisii Teaching and Referral Hospital
        • physical_addressKisii Town
        • contact_detailsP.O Box 92-40200 Kisii
        • contact_personJoyce Otieno
        • site_capacity(null)
        • misc(null)
        • created2021-10-22 14:09:46
        • modified2021-10-27 09:16:06
        • County(array)
          • id45
          • county_nameKisii
          • created2012-06-15 10:27:25
          • modified2012-06-15 10:27:25
      • 5(array)
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        • application_id1075
        • county_id43
        • site_nameMbita Sub-County Hospital
        • physical_addressMbita Town
        • contact_detailsP.O Box 50-40305 Mbita
        • contact_personJoyce Otieno
        • site_capacity(null)
        • misc(null)
        • created2021-10-22 14:09:46
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        • County(array)
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          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
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        • site_nameRongo Sub-County Hospital
        • physical_addressRongo Town
        • contact_detailsP.O Box 258-40404 Rongo
        • contact_personJoyce Otino
        • site_capacity(null)
        • misc(null)
        • created2021-10-22 14:10:56
        • modified2021-10-27 09:16:06
        • County(array)
          • id44
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          • created2012-06-15 10:27:16
          • modified2012-06-15 10:27:16
    • Sponsor(array)
      • 0(array)
        • id547
        • application_id1075
        • sponsorNational Institutes of Health
        • sponsor_typeResearch Institution
        • contact_personEunice Kennedy Shriver
        • address9000 Rockville Pike, Bethesda, Maryland 20892
        • telephone_number301-451-4411
        • fax_number
        • cell_number301-451-4411
        • email_addresslac@mail.nih.gov
        • created2021-10-22 13:24:10
        • modified2021-10-27 09:16:06
  • 1(array)
    • Application(array)
      • id1333
      • user_id865
      • trial_status_id1
      • abstract_of_study<p>\n <strong>Background: </strong>Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs) which bear 90% of deaths. Access to cervical precancer treatment is key to prevention cervical cancer in LMICs. Current precancer treatments rely on healthcare workers who may be out of reach for many women. Development of a patient-controlled cervical precancer treatment can significantly improve access in remote areas and promote secondary prevention of cervical cancer.</p>\n<p>\n <strong>Objectives:</strong> This is a Phase I trial  among 18 HIV-positive and HIV-negative women in Kenya investigating use of artesunate vaginal pessaries as treatment for cervical precancer among women screening positive for cervical precancer who need excisional treatment. The primary objective will be safety of self-administered artesunate pessaries. Secondary objectives will evaluate adherence, change in lesion size, histologic regression to CIN1 or less, and acceptability of artesunate pessaries. The central hypothesis of this study is that self-administered intravaginal Artesunate will be safe, and result in a clinical response among both HIV-positive and HIV-negative women with cervical precancer in LMICs.</p>\n<p>\n <strong>Methods: </strong>The study duration is 48 weeks. Participants will self-administer 200 mg of Artesunate pessary (vaginal insert) daily for 5 days, followed by a drug-free week, repeated for a total of 4 cycles (Artesunate self-administration on Weeks 1, 3, 5, 7). Safety and adherence will be assessed through review of symptoms diary and biweekly follow-up during the treatment phase. Clinical response, defined as a reduction in lesion size by 1 or more quadrants or regression to CIN1 or less will be assessed at week14. Participants with no improvement in lesion grade or size at week 14 will have excision. Participants with improvement in lesion grade or size at week 14 will be observed until Week 24, at which time they will have excision if a visible lesion is present or CIN2 or worse is detected on biopsy. Participants without a lesion at Week 24 or have had regression to CIN1 or less will be followed at Weeks 36, and 48 for surveillance. Any CIN2 or worse at follow-up will be managed with excision. Acceptability will be evaluated at Week 8 using a questionnaire and in-depth interviews. Data collection will be via electronic database. Data analysis will include quantitative and qualitative analysis.</p>\n
      • study_title<p>\n LCCC  2236: Phase I study of self-administered Artesunate pessaries (vaginal inserts) for treatment of cervical precancer in HIV positive and HIV-negative women in Kenya </p>\n
      • laymans_summary<p>\n Cancer of the cervix – which is the opening of the womb, is a leading cause of cancer death in Kenya and other low-income countries. Cervical cancer can be prevented if early changes in the cervix, called cervical precancer, are detected through screening and treated. Treatment for certain women with cervical precancer includes a procedure called Loop Electrosurgical Excision Procedure (LEEP), - during which the area of the cervix with precancer is removed. In countries like Kenya, this LEEP procedure is only available in referral hospitals which have trained consultants, and as a result it is difficult for women who need this treatment to it if they live far from a referral hospital. This LEEP procedure also increases the chance of a woman having not being able to carry a pregnancy to full term, because the cervix is shorter after the procedure. For these reasons, scientists are looking for alternative treatments for cervical precancer that can be used instead of LEEP. One such treatment that is being studied a medication called Artesunate that can be applied as a vaginal pessary directly by a woman for treatment of cervical precancer. Early studies in the United States have shown that Artesunate may be able to treat cervical precancer and women who use it may not need to get a LEEP procedure. This study is being done in order to understand whether women with cervical precancer in Kenya who need a LEEP procedure can instead be treated with Artesunate pessaries. The goals of the study are to understand whether it is safe for women to use artesunate pessaries in Kenya, whether women will use them as instructed (what doctors call adherence), whether women who use this pessary can have improvement or cure of their cervical precancer, (clinical response), and whether women using artesunate pessaries will find it an acceptable treatment.</p>\n
      • short_titleLCCC 2236 Study
      • protocol_noECCT/23/09/05
      • version_no1.3
      • date_of_protocol08-12-2023
      • study_drugArtesunate 200mg Vaginal Suppository
      • disease_conditionCervical Pre-cancer
      • 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_nameArtesunate
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgershonrota@gmail.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_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • 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_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGreshon Rota
      • declaration_date129-09-2023
      • declaration_principal_investigatorDr Jackton Omoto
      • declaration_date229-09-2023
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objective:</strong> To investigate the safety of self-administered Artesunate pessaries (vaginal inserts) among HIV-positive and HIV-negative women with cervical precancerous lesions referred for excision in Kenya</p>\n<p>\n  </p>\n<p>\n <strong>Secondary Objectives </strong></p>\n<ol>\n <li>\n To investigate adherence to self-administered Artesunate pessaries (vaginal inserts) for cervical precancer treatment among HIV-positive and HIV-negative women</li>\n <li>\n To evaluate change in lesion size following self-administered Artesunate pessaries (vaginal inserts) for cervical precancer treatment among HIV-positive and HIV-negative women</li>\n <li>\n To investigate the rate of histologic regression to CIN1 or less following self-administered Artesunate pessaries among participants with CIN2 or worse on biopsy, among HIV-positive and HIV-negative women</li>\n <li>\n To investigate acceptability of self-administered Artesunate pessaries for cervical precancer treatment among HIV-positive and HIV-negative women in Kenya </li>\n</ol>\n<p>\n  </p>\n<p>\n <strong>Exploratory Objective</strong></p>\n<ul>\n <li>\n To investigate longitudinal changes in HPV infection following intravaginal artesunate pessary use among HIV-positive and HIV-negative women.</li>\n <li>\n To investigate longitudinal changes in cervical microbiome following intravaginal artesunate pessary use among HIV-positive and HIV-negative women.</li>\n <li>\n To investigate longitudinal changes in the expression of biomarkers of local immune activation following intravaginal artesunate pessary use among HIV-positive and HIV-negative women.</li>\n <li>\n To investigate changes in artemisinin drug resistance patterns for treatment of malaria, if any, among study participants among HIV-positive and HIV-negative women. </li>\n</ul>\n
      • principal_inclusion_criteria<ol>\n <li>\n Age 18 years or older</li>\n <li>\n Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy</li>\n <li>\n Weight  greater than 50 Kg at study entry</li>\n <li>\n Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age</li>\n <li>\n Ability and willingness to provide informed consent </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Current pregnancy or breastfeeding status</li>\n <li>\n Current or past history of invasive cervical cancer</li>\n <li>\n History of total hysterectomy</li>\n <li>\n CD4 count <200 at time of study entry if HIV positive</li>\n <li>\n Presence of adenocarcinoma in situ on cervical biopsy</li>\n <li>\n Currently receiving systemic chemotherapy or radiation therapy for another cancer</li>\n <li>\n Current use of systemic immunosuppressants or steroids (>10 mg of prednisone or equivalent)</li>\n <li>\n Have a medical comorbidity that in the opinion of the investigator would interfere with study participation</li>\n <li>\n Prior chemotherapy within <1 month prior to day 1 of study treatment</li>\n <li>\n Male at birth</li>\n <li>\n Current use of efavirenz antiretroviral therapy</li>\n</ol>\n
      • primary_end_points<p>\n Safety will be assessed by evaluating the type, frequency, severity and duration of adverse events (AEs) using the U.S National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0). </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_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyThis is first administration through the vaginal route. The drug is approved for other routes of adminitartion including oral, parenteral and rectal.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>FACILITY</u></strong></p>\n<p>\n  </p>\n<ol>\n <li>\n <strong>The main study site is:</strong></li>\n</ol>\n<p>\n FACES Building</p>\n<p>\n Lumumba Sub-County Hospital</p>\n<p>\n Along Ondiek Highway</p>\n<p>\n Kisumu</p>\n<p>\n  </p>\n<p>\n The facility has</p>\n<ol>\n <li>\n Reception and waiting bay</li>\n <li>\n Six Clinic rooms</li>\n <li>\n Pharmacy</li>\n <li>\n Laboratory</li>\n <li>\n Data room</li>\n <li>\n Administration office</li>\n <li>\n Open Office</li>\n <li>\n Washrooms</li>\n</ol>\n<p>\n  </p>\n<p>\n All rooms are equipped with relevant furniture, equipment, and materials to facilitate the activities conducted in the rooms.</p>\n<p>\n  </p>\n<p>\n <strong><u>PERSONNEL </u></strong></p>\n<p>\n  </p>\n<p>\n <strong>Principal Investigators and role</strong></p>\n<p>\n <strong>Chemtai Mungo, MD, MPH</strong>: Dr. Chemtai Mungo will lead protocol implementation including brining subject matter expertise, she will oversee all aspects of protocol implementation, and lead data analysis, interpretation, dissemination of results and future Phase II grant writing and implementation.</p>\n<p>\n     </p>\n<p>\n <strong>Jackton Omoto, MBChB, MMed</strong>, Maseno University (Principal Co-Investigator): Dr. Omoto will lead protocol implementation and provide subject participant matter expertise, guidance on recruitment and retention, as well as support in building capacity of providers to deliver the intervention.</p>\n<p>\n  </p>\n<p>\n <strong>Co-Investigators and roles </strong></p>\n<p>\n <strong>Lisa Rahangdale, MD, MPH, UNC</strong> (Co-Investigator)<strong>:</strong> Dr. Rahangdale will provide      subject matter expertise and guidance on protocol implementation and provide guidance on data analysis, interpretation, dissemination and Phase II grant writing and future work.</p>\n<p>\n  </p>\n<p>\n <strong>Jennifer Tang, MD, MSCR, UNC</strong> (Co-investigator): Dr. Tang will provide      participant matter expertise and guidance on protocol implementation and provide guidance on data analysis, interpretation, dissemination and Phase II grant writing and future work.      </p>\n<p>\n  </p>\n<p>\n <strong>Hosea Akala, PhD, KEMRI/</strong>Walter Reed (Consultant)<strong>:</strong> Dr. Akala will provide      subject matter expertise related to malaria testing and resistance exploratory aims and will lead sample testing at the Walter Reed laboratory.</p>\n<p>\n <strong>Cirillus Ogollah, BSc, DipCM, </strong>KEMRI (Co-Investigator): Mr. Ogollah will support management of study field operations in Kenya including supervision and support of the study team, support the recruitment and enrollment strategies and support in dissemination of results.</p>\n<p>\n  </p>\n<p>\n <strong>Greshon Rota, BPharm, KEMRI</strong> (Study Pharmacist): Dr. Rota will participate in implementation of the study medicine and reporting of adverse effects. He will also act in liaison with the regulatory authorities to ensure study follows clinical trials rules and regulations.</p>\n<p>\n  </p>\n<p>\n <strong>Michael Hudgens, PhD; UNC </strong>(Biostatistician): Dr. Hudgens will be the lead statistician and provide expertise related to study design, power calculations, data analysis and interpretation.</p>\n<p>\n  </p>\n<p>\n <strong>Other personnel:</strong></p>\n<p>\n One Study Coordinator</p>\n<p>\n  </p>\n<p>\n Two Research Assistants</p>\n<p>\n  </p>\n<p>\n One Data Analyst</p>\n<p>\n  </p>\n
      • other_details_explanation<div>\n The study is an investigator-initiated (US-Based Kenyan Citizen) trial and, as such, does not have a pharmaceutical sponsor. </div>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration48 weeks
      • 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_areaFACES, Lumumba Sub-county Hospital
      • single_site_physical_addressLumumba Subcouty Hospita, Kisumu
      • single_site_contact_personCirillus Ogollah
      • single_site_telephone+254724717472
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site18
      • total_participants_worldwide18
      • 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_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameChemtai
      • investigator1_middle_name
      • investigator1_family_nameMungo
      • investigator1_qualificationMD, MPH
      • investigator1_professional_address3009 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599, United States
      • investigator1_telephone+15623106762
      • investigator1_emailChemtai_mungo@med.unc.edu
      • organisations_transferred_No
      • number_participants18
      • notification
      • approval_date11-01-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-12-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonAll reviewer questions have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-06 09:38:06
      • created2023-09-29 16:33:44
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id984
        • application_id1333
        • given_nameChemtai
        • middle_name
        • family_nameMungo
        • qualificationMD, MPH
        • professional_address3009 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599, United States
        • telephone+15623106762
        • emailChemtai_mungo@med.unc.edu
        • created2023-09-29 16:49:57
        • modified2023-12-19 08:28:22
      • 1(array)
        • id985
        • application_id1333
        • given_nameJackton
        • middle_name
        • family_nameOmoto
        • qualificationMBChB, MMED
        • professional_addressMaseno University School of Medicine, P.O.Box 3408, Kisumu, Kenya
        • telephone+254735731912
        • emailomotojackton@yahoo.com
        • created2023-09-29 16:59:15
        • modified2023-12-19 08:28:22
    • SiteDetail(array)
      • 0(array)
        • id1608
        • application_id1333
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2023-09-29 16:49:57
        • modified2023-12-19 08:28:22
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id699
        • application_id1333
        • sponsorLineberger Comprehensive Cancer Center
        • sponsor_typeResearch Institution
        • contact_person
        • addressUNC Lineberger Comprehensive Cancer Center, School of Medicine, Chapel Hill, NC 27599-7295
        • telephone_number +1(919) 966-3036
        • fax_number
        • cell_number+1 (919)-966-5281
        • email_addressinfo@UNCobgyn.org
        • created2023-09-29 16:49:57
        • modified2023-12-19 08:28:22
  • 2(array)
    • Application(array)
      • id312
      • user_id60
      • trial_status_id5
      • abstract_of_study<p>\n The STOP TB (Tuberculosis) partnership aims to halt and reverse the TB epidemic by 2015 through among other strategies, development of new drugs. Current Anti TB medication is taken for six months and is associated with poor adherence and emergence of drug resistant strains. Drug Resistant TB has higher case fatality rates due to the lack of efficacious medications. Shorter, novel regimens are required to address these challenges to achieve TB control goals.</p>\n<p>\n This phase III non inferiority trial aims to compare the safety, tolerability and efficacy of a three drug regimen of Pyrazinamide(1500mg daily), Moxifloxacin (400mg daily) and an investigational medication named PA-824 (100mg and 200mg daily) [<strong>MPaZ</strong>] for treatment of DS and Drug Resistant TB.  A total of 1200 DS TB patients will be randomized to receive (100mg of PA-824) in MPaZ for four months,(200mg of PA-824) in MPaZ for four months, (200mg of PA-824) in MPaZ for six months vs RHZE (Standard TB Treatment). An additional 300 patients with Multi Drug Resistant (MDR) TB on MPaZ for six months will be enrolled. Thereafter, follow up will occur for 24 months.</p>\n
      • study_title<p>\n Long Title:</p>\n<p>\n A Phase 3 Open Label Partially Randomised Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin plus PA-824 plus Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects with Drug Sensitive Smear Positive Pulmonary Tuberculosis and after 6 months of Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis</p>\n<p>\n  </p>\n<p>\n Short Title:</p>\n<p>\n STAND Study (Shortening Treatment by Advancing Novel Drugs)</p>\n
      • laymans_summary(null)
      • short_titleSTAND Study (Shortening Treatment by Advancing Novel Drugs)
      • protocol_noECCT/14/08/03
      • version_no1.0
      • date_of_protocol14-04-2014
      • study_drugPA-824-Moxifloxacin-Pyrazinamide
      • disease_conditionTuberculosis
      • 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_namePA-824-Moxifloxacin-Pyrazinamide
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressskiringa@gmail.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_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_applicantDr Grace Kaguthi
      • declaration_date128-07-2014
      • declaration_principal_investigatorDr Videlis Nduba
      • declaration_date228-07-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Drug Sensitive Arm: Smear positive Drug Sensitive TB, with an chest radiograph compatible with TB, without rifampin resistance. Aged >18years, weight  of equal or >30kg, of non child bearing potential or on effective birth control, and provides written informed consent</p>\n
      • principal_exclusion_criteria<p>\n Previous TB treatment in the last 3 years prior to screening; also, recent history of or current malaria treatment</p>\n<p>\n HIV infected patients with CD4<100cells/uL or WHO stage 4 disease or received parenteral antifungal medication within the last 30 days</p>\n<p>\n any medical condition that is a competing endpoint e.g non TB related conditions that could prevent, limit or confound protocol assessments, or result in death due to a high risk of a poor outcome e.g TB Meningitis, or other critical illness, unstable Diabetes Mellitus which required hospitalization in the past year</p>\n<p>\n significant ECG abnormalities</p>\n<p>\n allergies and hypersensitivity to trial IMP</p>\n<p>\n Fluoroquinolone or Pyrazinamide Resistance</p>\n<p>\n Participation in another clinical trial</p>\n
      • primary_end_points<p>\n incidence of bacteriologic failure* or relapse* or clinical failure* at 12 months from the start of therapy in three comparisons with a non‐inferiority comparison of each of the 3 experimental MPaZ treatment arm with the standard HRZE/HE treatment arm</p>\n<p>\n  </p>\n<p>\n <em>*Bacteriologic failure: During the treatment period, failure to attain culture conversion to negative status in liquid culture.</em></p>\n<p>\n <em>*Bacteriologic relapse: During the follow‐up period, failure to maintain culture conversion to negative status in liquid culture, with culture conversion to positive</em></p>\n<p>\n <em>*Clinical failure: A change from protocol‐specified TB treatment due to treatment failure, retreatment for TB during follow up, or TB‐related death.</em></p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyMycobacterial Characterisation: MTb DNA speciation by molecular tests, Drug Susceptibility Testing, MIC characterisation.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <u>Dr Videlis Nduba: (East Nairobi)</u></p>\n<p>\n Number of Staff: 20</p>\n<p>\n Study Coordinator: Dr Grace Kaguthi</p>\n<p>\n Site Facilities: Spacious Clinic Rooms and patient waiting bay, Emergency Crash Cart, Infection Control Measures, Pharmacy, Data and Quality Assurance Rooms, Monitoring Space</p>\n<p>\n Experience: Investigators have collectively>20 years Clinical Research Experience including previous TB drug trials</p>\n<p>\n <u>Dr Evans Amukoye(West Nairobi)</u></p>\n<p>\n Number of Staff: 31</p>\n<p>\n Study Coordinator: Barbara Miheso</p>\n<p>\n Site Facilities: ata Office, Coordination office, Central pharmacy ( at CRDR, KEMRI), The TB and the molecular laboratories ( at NUITM- CMR KEMRI)<br />\n The Study Clinic for patient recruitment and follow up ( at Mbagathi District Hospital)<br />\n <br />\n Emergency Facilities: Coptic Hospital</p>\n<p>\n Experience: participated in the OFLOTUB trial</p>\n
      • other_details_explanation<p>\n Kenya has a very high incidence and prevalence of TB disease and clinical sites are pre-eminent in the field of tuberculosis research. The simultaneous presence of a high rate and incidence of TB, an unmet medical need and the presence of a research infrastructure make this large phase 3 clinical trial appropriate for Kenya. The sponsor is based in the USA, which has a very low incidence of TB and it is therefore not appropriate to conduct the trial in the USA , and in South Africa, which will be participating in the trial (13 trial sites).</p>\n
      • other_details_regulatory_notapproved<h5>\n <span style=\"font-size:11px;\">South African Medicines Control Council – submitted on 16-May-2014.</span></h5>\n
      • other_details_regulatory_approved<p>\n None as yet have approved, submission and review is ongoing</p>\n
      • other_details_regulatory_rejected<p>\n none yet</p>\n
      • other_details_regulatory_halted<p>\n Trial hasn't been halted yet</p>\n
      • estimated_durationApproximately 4 years (18 month enrolment period for DS‐TB subjects plus up to 9 days pre‐treatment plus up to 6 months treatment and 24 month follow‐up from start of therapy. Enrolment into MDR‐TB arm may be continued after DS-TB arm is complete.
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyOpen Label Non Inferiority
      • design_controlled_comparatorStandard TB Treatment: (2
      • 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_countriesYes
      • multiple_member_states14
      • number_of_sitesTwo
      • multi_country_listThe study will also be conducted in South Africa, Tanzania, Uganda, Zambia, Russia, Ukraine, Philippines, Malaysia, Brazil, Peru, Thailand, China, Haiti and Georgia .
      • data_monitoring_committeeYes
      • total_enrolment_per_site50
      • total_participants_worldwide1500
      • 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_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Videlis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMbCHb, MPH
      • investigator1_professional_addressP.O. Box 47855-00100
      • investigator1_telephone+254 724 522 474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participants100
      • notification
      • approval_date17-08-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted01-04-2015
      • 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)
      • modified2020-09-10 17:53:31
      • created2014-07-25 13:04:42
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id214
        • application_id312
        • given_nameDr Videlis
        • middle_name
        • family_nameNduba
        • qualificationMbCHb, MPH
        • professional_addressP.O. Box 47855-00100
        • telephone+254 724 522 474
        • emailvnduba@gmail.com
        • created2014-07-25 13:11:46
        • modified2015-04-01 11:27:53
      • 1(array)
        • id215
        • application_id312
        • given_nameDr Evans
        • middle_name
        • family_nameAmukoye
        • qualificationMbCHb, MMED(Paed)
        • professional_addressP.O. Box 47855-00100
        • telephone+254 722 634383
        • emailamukoye@gmail.com
        • created2014-07-25 14:56:07
        • modified2015-04-01 11:27:53
    • SiteDetail(array)
      • 0(array)
        • id264
        • application_id312
        • county_id47
        • site_nameKEMRI-CRDR(East Nairobi)
        • physical_addressBahati Health Centre, Kamukunji Sub County
        • contact_details+254 724 522 474/ +254 729 489 743
        • contact_personDr Videlis Nduba/Dr Grace Kaguthi
        • site_capacity(null)
        • misc(null)
        • created2014-07-25 13:11:46
        • modified2015-04-01 11:27:53
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id265
        • application_id312
        • county_id47
        • site_nameKEMRI-CRDR(West Nairobi)
        • physical_addressSTAND Nairobi North Study Clinic, Mbagathi District Hospital, Off Mbagathi Way,
        • contact_detailsTel: +245 (020) 2724264/5Cell: +254722317368
        • contact_personDr Evans Amukoye/Paul Mwangi (Study Clinician)
        • site_capacity(null)
        • misc(null)
        • created2014-07-25 13:34:00
        • modified2015-04-01 11:27:53
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id172
        • application_id312
        • sponsorGlobal Alliance for TB Drug Development
        • sponsor_type(null)
        • contact_personDr Daniel E. Everitt
        • address40 Wall Street, 24th Floor New York, NY 10005 United States of America
        • telephone_number+1 646 616 8671
        • fax_number
        • cell_number+1 484 919 0017
        • email_addressdan.everitt@tballiance.org
        • created2014-07-25 13:11:46
        • modified2015-04-01 11:27:53
  • 3(array)
    • Application(array)
      • id1229
      • user_id21
      • trial_status_id1
      • abstract_of_study<div>\n SUMMARY INFORMATION </div>\n<div>\n LATA (Long-Acting Treatment in Adolescents)</div>\n<div>\n Long-Acting Treatment in Adolescents (LATA) - A randomised open-label 2-arm 96 week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa</div>\n<div>\n  </div>\n<div>\n  </div>\n<div>\n Study Design</div>\n<div>\n Open-label, randomised (1:1), 2-arm, multicentre, 96 weeks, non-inferiority trial</div>\n<div>\n  </div>\n<div>\n Participant population</div>\n<div>\n Adolescents aged 12 to 19 years of age living with HIV-1 who are not pregnant or breastfeeding, and are virologically-suppressed (HIV-1 RNA <50 copies/mL) for at least one year, without any known history of treatment failure, on a 3-drug combination ART consisting of an anchor drug with a 2-drug nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbone</div>\n<div>\n  </div>\n<div>\n Setting</div>\n<div>\n Kenya, South Africa, Uganda and Zimbabwe</div>\n<div>\n  </div>\n<div>\n Interventions to be Compared</div>\n<div>\n Continuous Therapy (CT) control group: Control group is continuous daily oral combination ART consisting of dolutegravir (DTG), with a tenofovir (TFV) and lamivudine(3TC)/emtricitabine(FTC) backbone</div>\n<div>\n Long Acting (LA) injectable group: Intervention group is long-acting injectable, cabotegravir (CAB) LA and rilpivirine (RPV) LA given every 8-weeks after an optional 4-week oral lead-in period with oral cabotegravir and rilpivirine, and two loading doses separated by 4 weeks.</div>\n<div>\n  </div>\n<div>\n Study Hypothesis</div>\n<div>\n CAB LA + RPV LA therapy will provide non-inferior sustained virological suppression compared to continuous treatment with DTG + TFV and 3TC or FTC</div>\n<div>\n  </div>\n<div>\n Primary Outcome Measure(s)</div>\n<div>\n The proportion of participants with confirmed virological rebound, defined as 2 consecutive plasma HIV-RNA ≥50 copies/mL at any time up to the 96-week assessment</div>\n<div>\n  </div>\n<div>\n Secondary Outcome Measure(s)</div>\n<div>\n Efficacy</div>\n<div>\n (i) Proportions of participants with HIV-RNA ≥50 copies/mL at 48 and 96 weeks using a modified FDA snapshot algorithm</div>\n<div>\n (ii) The proportion of participants with HIV-RNA ≥1000 copies/mL (confirmed) by week 96</div>\n<div>\n (iii) The proportion of participants with HIV-RNA ≥200 copies/mL (confirmed) by week 96</div>\n<div>\n (iv) The number and type of HIV mutations (reverse transcriptase and integrase) in participants with confirmed virological rebound</div>\n<div>\n (v) HIV-RNA <50 copies/mL at 24, 48 and 96 weeks</div>\n<div>\n <div>\n Safety</div>\n <div>\n (i) Change in metabolic parameters (lipids, HbA1c, phosphate), liver function tests (ALT), renal function (eGFR) from baseline to 96 weeks; change in anthropometric measures, including weight, from baseline to 48 and 96 weeks</div>\n <div>\n (ii) Time to any new or recurrent WHO grade 3 or WHO grade 4 event or death</div>\n <div>\n (iii) Incidence of serious, grade 3, 4 and 5, and treatment-modifying (of any grade) adverse events</div>\n <div>\n (iv) The proportion of participants with any change from baseline ART regimen</div>\n <div>\n (v) Change in CD4+ and CD8+ T-cell count from baseline to 48 and 96 weeks</div>\n <div>\n (vi) LA group only: incidence of injection-site reactions of any grade</div>\n <div>\n Patient-reported outcomes</div>\n <div>\n (i) Adherence, acceptability, wellbeing and neuropsychiatric problems (e.g. depression, anxiety and sleep disturbance)</div>\n <div>\n (ii) LA group only: perception of injection</div>\n <div>\n (iii) Healthcare resource utilisation (as a sub-study outcome)</div>\n <div>\n (iv) Health-related quality-of-life (as a sub-study outcome)</div>\n <div>\n (v) Perception of body shape using Stunkard figure rating scales (as a sub-study outcome)</div>\n <div>\n  </div>\n <div>\n Randomisation</div>\n <div>\n Participants will be randomised 1:1 to one of the two treatment groups</div>\n <div>\n  </div>\n <div>\n Number of Participants to be Studied</div>\n <div>\n N=460, with 230 in each group</div>\n <div>\n  </div>\n <div>\n Duration of follow-up in the trial</div>\n <div>\n A minimum of 96 weeks per participant – individual follow-up will continue until the last participant reaches 96 weeks follow-up.a</div>\n <div>\n a Participants on LA injectables will be followed for safety (Serious Adverse Events and Notable Adverse Events, and Notable Events) for 12 months after their last injections received whilst participating in LATA; this means follow-up of patients in the LA group will continue for up to one year after end of randomised follow-up). For participants who continue to receive LA injectables after this 12 month post-LATA period, safety reporting requirements will be described in a separate protocol. See section 6.11</div>\n <div>\n  </div>\n <div>\n Ancillary Studies/Substudies</div>\n <div>\n Nested substudies:</div>\n <div>\n â–ª Social science</div>\n <div>\n â–ª Neuropsychiatric toxicity</div>\n <div>\n â–ª Metabolic</div>\n <div>\n â–ª Health economics</div>\n <div>\n â–ª Pharmacology</div>\n</div>\n<p>\n  </p>\n
      • study_title<p>\n Long-Acting Treatment in Adolescents (LATA) A randomised open-label 2-arm 96 week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa</p>\n
      • laymans_summary<div>\n In LATA we will compare two different ways of taking HIV medicines. In the trial you are randomised, with an equal chance that you will either go into the long-acting injectable group or get a daily tablet by mouth. This is what happens depending on which group you are randomised to:</div>\n<div>\n • <u>Long-Acting Injectable Group</u>: In this group, there are 2 options. The first is to stay on your current HIV medicines by mouth and then to start the injections around 4 weeks after randomisation. If this is the choice, then at week 4, the first 2 injections will be given, the second t o ill be given 4 ee s later, and then it’s every 8 ee s from then on. The second option is to switch to taking one tablet of cabotegravir and one tablet of rilpivirine for approximately 4-5 weeks before starting the injections. The reason that some people might choose to have the tablet forms first, is to make sure they tolerate them. This is called an oral lead-in (OLI). For the OLI group, and as long as liver test results at 4 weeks are within normal levels, the first two injections will be given at around 5 weeks (about a week after the week 4 visit), the second two are given 4 weeks later, and then it’s every 8 ee s from then on.</div>\n<div>\n • C<u>ontinuous Oral Treatment Group</u>: this group will continue to take all their HIV medicines every day by mouth. However, to join the trial, some participants will have to change some of their oral medications as the combination being used is dolutegravir with tenofovir plus either lamivudine or emtricitabine as a single tablet taken once a day, called TLD.</div>\n
      • short_titleLATA
      • protocol_noECCT/23/05/07
      • version_no1.0
      • date_of_protocol01-12-2021
      • study_drugCarbotegravir and Rilpivirine
      • 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_nameCabotegravir,Rilpivirine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressviola.kirui@gmail.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_countries(null)
      • 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_plan1
      • applicant_contractual_agreement1
      • declaration_applicantFlorence Njulu
      • declaration_date118-05-2023
      • declaration_principal_investigatorAbraham m. Siika
      • declaration_date218-05-2023
      • placebo_presentNo
      • study_objectives<div>\n 1.2.2 PRIMARY OUTCOME</div>\n<div>\n The proportion of participants with confirmed virological rebound, defined as 2 consecutive plasma HIV-RNA ≥50 copies/mL at any time up to the 96-week assessment.</div>\n<div>\n  </div>\n<div>\n 1.2.3 SECONDARY OUTCOMES</div>\n<div>\n 1.2.3.A EFFICACY</div>\n<div>\n (i) Proportion of participants with HIV-RNA ≥50 copies/mL at 48 and 96 weeks using a modified FDA snapshot algorithm</div>\n<div>\n (ii) The proportion of participants with HIV-RNA ≥1000 copies/mL (confirmed) by week 96</div>\n<div>\n (iii) The proportion of participants with HIV-RNA ≥200 copies/mL (confirmed) by week 96</div>\n<div>\n (iv) The number and type of HIV mutations (reverse transcriptase and integrase) in participants with confirmed virological rebound</div>\n<div>\n <div>\n (v) HIV-RNA <50 copies/mL at 24, 48 and 96 weeks</div>\n <div>\n avirological rebound is defined as two consecutive HIV-RNA ≥50 copies/mL. As obtaining resistance data is challenging when viral loads are very low, resistance testing may need to be restricted to samples with a higher VL where the chances of being able to sequence are greater; this will also be dependent on available technologies for testing.</div>\n <div>\n  </div>\n <div>\n 1.2.3.B SAFETY</div>\n <div>\n (i) Change in toxicity profile including change in metabolic parameters (lipids, HbA1c, phosphate),</div>\n <div>\n liver function tests (ALT), renal function (eGFR) from baseline to 96 weeks; change in anthropometric measures, including weight, from baseline to 48 and 96 weeks</div>\n <div>\n (ii) Time to any new or recurrent WHO grade 3 or WHO grade 4 event or death</div>\n <div>\n (iii) Incidence of serious, grade 3, 4 and 5, and treatment-modifying (of any grade) adverse events</div>\n <div>\n (iv) The proportion of participants with any change from baseline ART regimen</div>\n <div>\n (v) Change in CD4+ and CD8+ T-cell count from baseline to 48 and 96 weeks</div>\n <div>\n (vi) LA group only: incidence of injection site reactions of any grade</div>\n <div>\n  </div>\n <div>\n 1.2.3.C PATIENT-REPORTED OUTCOMES</div>\n <div>\n (i) Adherence (days missed of oral medication and/or missed scheduled injection visits), acceptability, wellbeing and neuropsychiatric problems (e.g. depression, anxiety and sleep disturbance)</div>\n <div>\n (ii) LA group only: perception of injection</div>\n <div>\n (iii) Healthcare resource utilisation (as a sub-study outcome)</div>\n <div>\n (iv) Health-related quality-of-life (as a sub-study outcome)</div>\n <div>\n (v) Perception of body shape using Stunkard figure rating scales (as a sub-study outcome)</div>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. HIV-1-positive</div>\n<div>\n 2. Aged 12-19 years</div>\n<div>\n 3. Aware of HIV status</div>\n<div>\n 4. Body weight ≥35Kg</div>\n<div>\n 5. On ART consisting of 2NRTI and a third agent</div>\n<div>\n 6. On ART for ≥1 year with no previous regimen change for treatment failure*</div>\n<div>\n 7. Virologically suppressed with all HIV-1 RNA viral loads <50copies/mL¥ in the last 12 months up to and including screening. Additionally, there must be one result <50copies/mL¥ at least 12 months prior to screening and the viral load at trial screening must be <50 copies/mL</div>\n<div>\n 8. Written informed consent provided by participant (if aged 18 to 19 years) and/or carer/legal guardian (if participant aged 12 to 17 years) as appropriate</div>\n<div>\n 9. Written informed assent in participants aged 12 to 17 years</div>\n<div>\n 10. Females who are sexually active must be willing to adhere to highly effective methods of contraception⌂</div>\n
      • principal_exclusion_criteria<div>\n 1. Known HIV-2 positive</div>\n<div>\n 2. Females who are pregnant or breastfeeding</div>\n<div>\n 3. Females who plan to become pregnant during the trial follow-up or are sexually active and are unwilling to avoid pregnancy for the duration of the trial</div>\n<div>\n 4. Moderate or high-risk score on the Columbia-Suicide Severity Rating Scale</div>\n<div>\n 5. Hepatitis B SAg positive</div>\n<div>\n 6. ALT ≥3 x upper limit of normal</div>\n<div>\n 7. On treatment for active TB</div>\n<div>\n 8. Known contraindication to receipt of dolutegravir, cabotegravir, rilpivirine, emtricitabine/ lamivudine and any formulation of tenofovir</div>\n<div>\n 9. Participants determined by the investigator to have a high risk of seizure, including those with unstable or poorly controlled seizure disorder</div>\n<div>\n 10. Unwilling or contraindication to receiving injections</div>\n<div>\n 11. Contraindication to receiving injectable agents in the buttock area</div>\n<div>\n 12. Underlying medical condition (e.g. bleeding disorder; use of warfarin) that in the opinion of the investigator precludes participation</div>\n<div>\n 13. Previous randomisation in the BREATHER Plus trial</div>\n<div>\n 14. Known majora resistance to non-nucleoside reverse transcriptase inhibitors or integrase inhibitors</div>\n
      • primary_end_points<p>\n The proportion of participants with confirmed virological rebound, defined as 2 consecutive plasma HIV-RNA ≥50 copies/mL at any time up to the 96-week assessment</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_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<ol 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 Prof. Abraham M. Siika                                 Site Leader</li>\n <li style=\"line-height: 20px;\">\n Dr. Cecilia Kiilu                                        Principal Investigator</li>\n <li style=\"line-height: 20px;\">\n Jairus Kipyego                                                   Study Clinician          </li>\n <li style=\"line-height: 20px;\">\n Vincent KIpchirchir                                                Study Clinician                      </li>\n <li style=\"line-height: 20px;\">\n Chris Sande Mboya                                       Study Nurse</li>\n <li style=\"line-height: 20px;\">\n Viola Kirui                                             Site Manager</li>\n <li style=\"line-height: 20px;\">\n Cecilia Chebet                                                Recruitment officer</li>\n <li style=\"line-height: 20px;\">\n Julie Choge                                                     Recruitment officer</li>\n <li style=\"line-height: 20px;\">\n Amina Msuo Shali                                         Recruitment officer</li>\n <li style=\"line-height: 20px;\">\n Wilson Ekiru                                                  Assistant data manger</li>\n <li style=\"line-height: 20px;\">\n Martha Mokaya                                             Data manger           </li>\n <li style=\"line-height: 20px;\">\n Natalie Sang                                         Pharmacist of record</li>\n <li style=\"line-height: 20px;\">\n Beatrice Jakait                                               Backup pharmacist</li>\n <li style=\"line-height: 20px;\">\n Salina Cherutich                                            Pharmaceutical technologist</li>\n</ol>\n
      • other_details_explanation<p>\n The study focuses on Sub-Saharan Africa</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration96 weeks per participant
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard of Care
      • design_controlled_other_medicinalYes
      • 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_stateNo
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites
      • multi_country_listKenya, Uganda, South Africa, Zimbabwe.
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwide460
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyChildren in children\'s homes
      • investigator1_given_nameAbraham
      • investigator1_middle_name
      • investigator1_family_nameSiika
      • investigator1_qualificationMBChB, MMed, MSc
      • investigator1_professional_addressP.O Box 4606-30100 Eldoret Kenya
      • investigator1_telephone+254721280785
      • investigator1_emailabrahamsiika@gmail.com
      • organisations_transferred_No
      • number_participants90
      • notification
      • approval_date11-09-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-05-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed conclusively.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-04 19:44:55
      • created2023-03-01 12:37:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id914
        • application_id1229
        • given_nameAbraham
        • middle_name
        • family_nameSiika
        • qualificationMBChB, MMed, MSc
        • professional_addressP.O Box 4606-30100 Eldoret Kenya
        • telephone254721280785
        • emailabrahamsiika@gmail.com
        • created2023-03-27 15:15:09
        • modified2023-05-18 13:47:12
    • SiteDetail(array)
      • 0(array)
        • id1463
        • application_id1229
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2023-03-27 15:15:09
        • modified2023-05-18 13:47:12
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id651
        • application_id1229
        • sponsorUCL
        • sponsor_typeResearch Institution
        • contact_personProfessor Sarah L. Pett
        • addressUniversity College London, Gower Street, London, WC1E 6BT
        • telephone_number+44 (0) 20 7679 2000
        • fax_number
        • cell_number+44 (0) 20 7679 2000
        • email_addresss.pett@ucl.ac.uk
        • created2023-03-27 15:15:09
        • modified2023-05-18 13:47:12
  • 4(array)
    • Application(array)
      • id1358
      • user_id693
      • trial_status_id1
      • abstract_of_study<p>\n <u><strong>STUDY RATIONALE</strong></u></p>\n<p>\n The purpose of this study is to long-term evaluation of participants receiving CAB LA who are at risk of acquiring HIV and continue to benefit from CAB LA administration as evidenced by HIV negative status. Participants will transition from the DAIDS sponsored PrEP studies HPTN 083 and HPTN 084 parent studies and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, and safety as specified in the protocol.</p>\n<div>\n <u><strong>OBJECTIVES AND ENDPOINTS</strong></u></div>\n<div>\n Primary Objective: To describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.</div>\n<div>\n Endpoint: Number and characteristics of new HIV infections, including detection of resistance to CAB while on study.</div>\n<div>\n  </div>\n<div>\n Secondary Objective: To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.</div>\n<div>\n Endpoint: Incidence and severity of serious adverse events, Grade 3 and Grade 4 ISRs, and any clinical or laboratory adverse events leading to discontinuation of CAB while on study.</div>\n<div>\n  </div>\n<div>\n <u><strong>OVERALL DESIGN</strong></u></div>\n<div>\n This is a non-randomized, open label, multi-center long-term follow-up study with one treatment arm. The purpose of this study is long-term evaluation of eligible participants, who have completed DAIDS sponsored parent studies HPTN 083 and HPTN 084, and associated sub-studies, for new HIV diagnosis, SAEs, Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal.</div>\n<div>\n  </div>\n<div>\n All participants who meet the screening eligibility criteria will be allowed to enroll in this study, continue receiving CAB LA 600 mg (200 mg/mL) intramuscular injections, and will be considered evaluable. Based on the design of the parent studies, approximately 3500 participants at risk of acquiring HIV infection could enroll into this study.</div>\n<div>\n  </div>\n<div>\n Study participation will extend for up to 3 years or until CAB LA receives local regulatory approval (by country) and is available in those countries, or until other access occurs from another source (e.g., government programs, aid programs, assistance programs, commercial availability, etc.), or if the participant no longer benefits from CAB LA, or meets a protocol defined stopping criteria.</div>\n
      • study_title<p>\n Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition</p>\n
      • laymans_summary<p>\n CAB LA IM every 2 months is approved in some countries as PrEP to reduce the risk of sexually acquired HIV in at-risk individuals. While awaiting approval and general availability of injectable cabotegravir for HIV prevention, there is, need to ensure continuous availability of an effective product among study participants who have benefited from it within the study context, while also evaluating long-term effects of CAB-LA. The purpose of this study is long-term evaluation of eligible participants who have completed US National Institute of Health sponsored pre-exposure prophylaxis (PrEP) study (HPTN 084) at the KEMRI Kisumu site. All participant will be given access to the injectable product. Eligible participants will be HIV negative at the last visit in the parent study (HPTN 084) and will have  good tolerance to the injectable product. The Kisumu Clinical Research Site (CRS) will enroll up to 58 participants. Each participant will be followed up for a duration of up to 3 years. Participants will continue to receive injectable cabotegravir and be followed up for new HIV infections, adverse events, serious safety concerns, and reasons leading to withdrawal. While ensuring continued access, we anticipate that the study will provide evidence on long-term safety of injectable cabotegravir when used for HIV prevention.</p>\n
      • short_title221163 PALISADE
      • protocol_noECCT/24/03/05
      • version_no1
      • date_of_protocol30-06-2023
      • study_drugCabotegravir Long Acting (CAB LA)
      • 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_nameCabotegravir Long Acting (CAB LA)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.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_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • 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_plan1
      • applicant_contractual_agreement1
      • declaration_applicantKarabo Tsoku
      • declaration_date108-03-2024
      • declaration_principal_investigatorDr Grace Mboya
      • declaration_date208-03-2024
      • placebo_presentNo
      • study_objectives<p>\n Primary Objective: To describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.</p>\n<p>\n Secondary Objective: To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. Participants must be currently enrolled and ongoing in one of the following studies: HPTN 083, HPTN 084, or HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies. Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study.</div>\n<div>\n 2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.</div>\n<div>\n 3. Participants must have a nonreactive HIV test at Screening (rapid test, antigen/antibody test and HIV-1 RNA from the parent study/sub-study) and Day 1 (a rapid test and HIV Immunoassay [Antigen/Antibody test]).</div>\n<div>\n 4. SEX: Males and Females: All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs.</div>\n<div>\n 5. INFORMED CONSENT: Participant or caregiver/legal guardian is able and willing to provide signed informed consent as described in Section 11.1.4, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.</div>\n
      • principal_exclusion_criteria<div>\n 1. Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF/FTC bridging may be enrolled following consultation with the Medical Monitor.</div>\n<div>\n 2. Previous permanent discontinuation from IP in the parent study/sub-study.</div>\n<div>\n 3. Known ALT >5 x ULN or ALT>3 x ULN and bilirubin >1.5 x ULN (with >35% direct bilirubin).</div>\n<div>\n 4. Participants with known hepatitis B infection at any time prior to entry (as evidence by a positive Hepatitis B virus surface antigen positive and/or quantifiable Hepatitis B DNA PCR).</div>\n<div>\n 5. Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator).</div>\n<div>\n 6. Known history of cirrhosis with or without viral hepatitis co-infection.</div>\n<div>\n 7. Participant is currently participating in or has participated in a study (other than the studies listed in Inclusion Criteria 1) with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from the Medical Monitor is granted.</div>\n<div>\n 8. Presence of any history of allergy/sensitivity to any of the study drug.</div>\n<div>\n 9. Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator.</div>\n<div>\n 10. Participant has a gluteal implant, tattoo or other dermatological condition overlying the buttock region which in the opinion of the investigator or designee may interfere with the injection or interpretation of ISRs.</div>\n<div>\n 11. Coagulopathy (primary or iatrogenic) which would contraindicate IM injection.</div>\n<div>\n <div>\n 12. Use of any disallowed medications at time of screening.</div>\n <div>\n 13. Anticipated need for HCV therapy with interferon or any drugs that have potential for adverse drug:drug interactions with study treatment throughout the entire study period.</div>\n <div>\n <div>\n 14. Participant is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.</div>\n <div>\n 15. Any condition (including but not limited to alcohol and drug use) that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.</div>\n </div>\n</div>\n
      • primary_end_points<p>\n Primary Objective Endpoints: Number and characteristics of new HIV infections, including detection of resistance to CAB while on study.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • 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_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n KEMRI CGHR is located in Kisumu, Western Kenya. The Clinical Research Centre (CRC) is based at the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). The study clinic will be the CRC at the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Enrollment and follow up visits will be conducted at the CRC at the JOOTRH grounds, at the participant’s residence, or other suitable location depending on situation and request of the participant. Key site staff are highlighted below:</p>\n<table align=\"left\" border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:666px;\" width=\"666\">\n <tbody>\n <tr>\n <td style=\"width:150px;\">\n <p>\n <strong><u>Name</u></strong></p>\n </td>\n <td style=\"width:132px;\">\n <p>\n <strong><u>Role</u></strong></p>\n </td>\n <td style=\"width:384px;\">\n <p>\n <strong><u>Contribution</u></strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Dr. Grace Mboya, MBChB</p>\n <p>\n  </p>\n </td>\n <td style=\"width:132px;\">\n <p>\n Principal Investigator,</p>\n <p>\n KEMRI-CGHR</p>\n </td>\n <td style=\"width:384px;\">\n <p>\n Overall responsibility for the study at the site. Will oversee the entire project, and guide site-specific study design, protocol development, assessment tools; data analysis and report writing; ensure the study protocol and required amendments and annual renewals are approved by the relevant Institutional Review Board (IRB) institutions; will constitute, train and maintain a highly qualified and motivated study team.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Dr. Victor Mudhune,</p>\n <p>\n BPharm, MPH</p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:132px;\">\n <p>\n Co-Investigator,</p>\n <p>\n KEMRI-CGHR</p>\n <p>\n  </p>\n </td>\n <td style=\"width:384px;\">\n <p>\n Will oversee fiscal, administrative and operational conduct of the study, and offer guidance and support to the study team . Will provide input for data analysis, contribute to site-specific addendum design, protocol development, and study implementation including data analysis and report writing.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Francis Angira,</p>\n <p>\n DCMS, ADPH, MPH</p>\n </td>\n <td style=\"width:132px;\">\n <p>\n Study Coordinator,</p>\n <p>\n KEMRI-CGHR</p>\n </td>\n <td style=\"width:384px;\">\n <p>\n Will provide substantial input into site-specific study design, protocol development, questionnaires, consent documents, site activation preparedness, and overall direction of the project; Will oversee budget development and control, daily study operations, implementation, monitoring, data analysis and writing of scientific as well as site-specific reports. Will supervise KEMRI Kisumu-based study staff. </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Dr. Valarie Opollo, PhD</p>\n </td>\n <td style=\"width:132px;\">\n <p>\n  Laboratory Director,</p>\n <p>\n KEMRI CGHR</p>\n </td>\n <td style=\"width:384px;\">\n <p>\n Will provide input into site-specific study design, protocol development and assessment tools; as well as laboratory oversight for the study. Will provide input for study implementation, data analysis and report writing.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:150px;\">\n <p>\n Dr. Peter Okech,</p>\n <p>\n BPharm</p>\n </td>\n <td style=\"width:132px;\">\n <p>\n Co-Investigator and Lead Pharmacist,</p>\n <p>\n KEMRI-CGHR</p>\n </td>\n <td style=\"width:384px;\">\n <p>\n Will oversee all pharmaceutical aspects of the study and maintain oversight of study products. Will provide input for development of assessment tools, study implementation, data analysis and report writing.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<div>\n The 221163 study is a long term follow up study including only those participants who were in the DAIDS sponsored HPTN 083 and 084 studies. 221163 is Sponsored by ViiV Healthcare UK Limited. To clarify the 221163 study will not be conducted in the United Kingdom (the country of origin for the protocol and corporate headquarters of the protocol sponsor) as the country was not part of the DAIDS sponsored HPTN 083 and 084 studies.</div>\n
      • other_details_regulatory_notapproved<p>\n <strong>List of Competent Authorities and Ethics Committees outside the EU/EEA to which the Application will be, or has been, Submitted and Details of Decisions as of 28Nov2023</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:178px;height:16px;\">\n <p>\n  <strong>Country </strong></p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n <strong>Date Submitted </strong></p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n <strong>Outcome </strong></p>\n <p>\n <strong>Date </strong></p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:534px;height:7px;\">\n <p>\n <strong>ARGENTINA </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:12px;\">\n <p>\n Ethics Committee</p>\n </td>\n <td style=\"width:178px;height:12px;\">\n <p>\n 26 Oct 2023</p>\n </td>\n <td style=\"width:178px;height:12px;\">\n <p>\n pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:16px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n Planned</p>\n <p>\n Dec 2023</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:534px;height:7px;\">\n <p>\n <strong>BRAZIL </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:12px;\">\n <p>\n Ethics Committee</p>\n </td>\n <td style=\"width:178px;height:12px;\">\n <p>\n 13 Nov 2023</p>\n </td>\n <td style=\"width:178px;height:12px;\">\n <p>\n pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:7px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:7px;\">\n <p>\n 16 Oct 2023</p>\n </td>\n <td style=\"width:178px;height:7px;\">\n <p>\n pending</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:534px;height:7px;\">\n <p>\n <strong>BOTSWANA </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:16px;\">\n <p>\n Ethics Committee</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n Planned</p>\n <p>\n Dec 2023</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:16px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n Planned</p>\n <p>\n Dec 2023</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:534px;height:7px;\">\n <p>\n <strong>ESWATINI </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:12px;\">\n <p>\n Ethics Committee</p>\n </td>\n <td style=\"width:178px;height:12px;\">\n <p>\n 24 Nov 2023</p>\n </td>\n <td style=\"width:178px;height:12px;\">\n <p>\n pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:16px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n Planned</p>\n <p>\n Jan 2024</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:534px;height:7px;\">\n <p>\n <strong>KENYA </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:16px;\">\n <p>\n Ethics Committee</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n Planned</p>\n <p>\n Nov 2023</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:16px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n Planned</p>\n <p>\n Mar 2024</p>\n </td>\n <td style=\"width:178px;height:16px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:47px;\">\n <p>\n <strong>MALAWI </strong></p>\n <p>\n Ethics Committee</p>\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:47px;\">\n <p>\n Planned</p>\n <p>\n Jan 2024</p>\n <p>\n Planned</p>\n <p>\n Apr 2024</p>\n </td>\n <td style=\"width:178px;height:47px;\">\n <p>\n To be submitted</p>\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:47px;\">\n <p>\n <strong>PERU </strong></p>\n <p>\n Ethics Committee</p>\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:47px;\">\n <p>\n 24 Oct 2023</p>\n <p>\n Planned</p>\n <p>\n Dec 2023</p>\n </td>\n <td style=\"width:178px;height:47px;\">\n <p>\n pending</p>\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:534px;height:7px;\">\n <p>\n <strong>S</strong><strong>OUTH </strong><strong>A</strong><strong>FRICA </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:12px;\">\n <p>\n Ethics Committee</p>\n </td>\n <td style=\"width:178px;height:12px;\">\n <p>\n 06 Oct 2023</p>\n </td>\n <td style=\"width:178px;height:12px;\">\n <p>\n pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:7px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:7px;\">\n <p>\n 20 Oct 2023</p>\n </td>\n <td style=\"width:178px;height:7px;\">\n <p>\n pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:43px;\">\n <p>\n <strong>THAILAND </strong></p>\n <p>\n Ethics Committee</p>\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:43px;\">\n <p>\n  </p>\n <p>\n 03 Oct 2023</p>\n <p>\n 24 Nov 2023</p>\n </td>\n <td style=\"width:178px;height:43px;\">\n <p>\n  </p>\n <p>\n pending</p>\n <p>\n pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:42px;\">\n <p>\n <strong>UGANDA </strong></p>\n <p>\n Ethics Committee</p>\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:42px;\">\n <p>\n Planned</p>\n <p>\n Dec 2023</p>\n <p>\n Planned</p>\n <p>\n Feb 2024</p>\n </td>\n <td style=\"width:178px;height:42px;\">\n <p>\n  </p>\n <p>\n To be submitted</p>\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:47px;\">\n <p>\n <strong>VIETNAM </strong></p>\n <p>\n Ethics Committee</p>\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:47px;\">\n <p>\n Planned</p>\n <p>\n Dec 2023</p>\n <p>\n Planned</p>\n <p>\n Dec 2023</p>\n </td>\n <td style=\"width:178px;height:47px;\">\n <p>\n  </p>\n <p>\n To be submitted</p>\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:178px;height:47px;\">\n <p>\n <strong>ZIMBABWE </strong></p>\n <p>\n Ethics Committee</p>\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:178px;height:47px;\">\n <p>\n Planned</p>\n <p>\n Nov 2023</p>\n <p>\n Planned</p>\n <p>\n Dec 2023</p>\n </td>\n <td style=\"width:178px;height:47px;\">\n <p>\n  </p>\n <p>\n To be submitted</p>\n <p>\n To be submitted</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n (Approvals pending). The following table outlines the expected participating countries and sites involved in the study.</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:166px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width:90px;\">\n <p>\n <strong>Target Sites</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Argentina</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 2 sites</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Brazil</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 4 sites</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Peru</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 5 sites</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Thailand</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 2 sites</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Vietnam</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 1 site</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Botswana</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 1 site</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Kenya</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 1 site</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Malawi</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 2 sites</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n South Africa</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 8 sites</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n eSwatini</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 1 site</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Uganda</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 3 sites</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:166px;\">\n <p>\n Zimbabwe</p>\n </td>\n <td style=\"width:90px;\">\n <p>\n 5 sites</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable. None of the Regulatory Authorities or Ethics Committees have rejected this trial.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationUp to 36 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
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      • design_controlled_other_medicinal
      • design_controlled_placebo
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      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Kisumu Clinical Research Site
      • single_site_physical_addressJaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH), Off Kakamega Road, P.O. Box 1578, Kisumu 40100
      • single_site_contact_personDr Grace Mboya
      • single_site_telephone+254705300452
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states12
      • number_of_sites
      • multi_country_listArgentina, Brazil, Botswana, eSwatini, Kenya, Malawi, Peru, South Africa, Thailand, Uganda, Vietnam, Zimbabwe
      • data_monitoring_committeeNo
      • total_enrolment_per_site55
      • total_participants_worldwide3500
      • 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_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
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      • number_participants55
      • notification
      • approval_date10-05-2024
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      • date_submitted08-03-2024
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      • modified2025-03-19 16:19:52
      • created2023-12-08 07:44:42
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1025
        • application_id1358
        • given_nameGrace
        • middle_name
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        • professional_addressKEMRI Kisumu Clinical Research Site, Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH), Off Kakamega Road, P.O. Box 1578, Kisumu 40100
        • telephone+254705300452
        • emailGMboya@kemri.go.ke
        • created2023-12-08 09:27:33
        • modified2024-03-08 22:04:59
    • SiteDetail(array)
      • 0(array)
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        • misc(null)
        • created2023-12-08 09:27:33
        • modified2024-03-08 22:04:59
        • County(empty)
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      • 0(array)
        • id714
        • application_id1358
        • sponsorViiV Healthcare UK Limited
        • sponsor_typeIndustry
        • contact_personTo Be Confirmed
        • address980 Great West Road Brentford, Middlesex, TW8 9GS, United Kingdom
        • telephone_number+44 (0)20 8 380 6200
        • fax_number
        • cell_number+44 (0)20 8 380 6200
        • email_addressPPDSubmissionsMembers.SM@ppd.com
        • created2023-12-08 09:27:33
        • modified2024-03-08 22:04:59
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