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• trial_statuses(array)
  • 1Recruiting
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  • 3Suspended
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  • 6In follow-up
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  • 8Writing-up
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• applications(array)
  • 0(array)
    • Application(array)
      • id296
      • user_id38
      • trial_status_id7
      • abstract_of_study<p>\n Less than a year after Artemisinin-based combination therapies (ACTs) were recommended for the treatment of falciparum malaria, concerns about artemisinin resistance development along the Cambodian-Thai border were voiced. Artemisinin resistance has been poorly characterized, and is difficult to detect by classical laboratory approaches.  In-vitro tests have not consistently detected reduced pharmacodynamic responses to artemisinin drugs, and molecular markers conferring artemisinin resistance have not yet been determined.  This study aims to assess the degree of artemisinin resistance in adult and pediatric subjects presenting with uncomplicated falciparum malaria in Western Kenya. The study treatments will be Artemether Lumefantrine (AL) and Dihydroartemisinin Piperaquin (DHA PPQ). In-vivo and in-vitro methodologies, including pharmacokinetic methods, will be employed. Data generated from this studywill potentially enable the identification of key markers that may assist in the early detection of resistance, and also to better understand the development of resistance to ACTs, and thus inform both local and international policy regarding ACT use.</p>\n
      • study_title<p>\n Therapeutic efficacy of dihydroartemisinin piperaquine and artemether lumefantrine for the treatment of uncomplicated malaria  in Kisumu County, Western Kenya</p>\n<p>\n Therapeutic efficacy of dihydroartemisinin piperaquine and artemether lumefantrine for the treatment of uncomplicated malaria  in Kisumu County, Western Kenya</p>\n
      • laymans_summary(null)
      • short_titleInvivo II study
      • protocol_noECCT/14/05/03
      • version_no3.3
      • date_of_protocol24-03-2014
      • study_drugArtemether Lumefantrine and Dihydroartemisinin Piperaquin
      • disease_conditionMalaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameArtemether Lumefantrine and Dihydroartemisinin Piperaquin
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
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      • applicant_prev_data(null)
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      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantVictorine Owira
      • declaration_date115-05-2014
      • declaration_principal_investigatorDr Ben Andagalu
      • declaration_date215-05-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ul>\n <li>\n Adult/child aged between 6 months and 65 years inclusive (minimum weight 11kg), presenting with a measured temperature of ≥37.5⁰C, or history of fever within 24 hours prior to presentation</li>\n <li>\n Mono-infection with <em>Plasmodium falciparum</em> (refer to section 7.6.11.2.1 below)</li>\n <li>\n Baseline parasitemia of 2000 - 200,000 asexual parasites/µl</li>\n <li>\n Ability to provide informed consent</li>\n <li>\n Willingness and ability to comply with the study protocol for the duration of the study</li>\n <li>\n Willingness to remain in the hospital for 3 days</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Presence of signs of severe malaria as defined in section 7.3.2.1 below</li>\n <li>\n Presence of severe anemia, defined as hemoglobin level below 6 g/dl</li>\n <li>\n Presence of mixed Plasmodium infection, or mono-infection of non-falciparum Plasmodium</li>\n <li>\n Inability to take oral medication</li>\n <li>\n History of allergy or contraindications to the study treatments</li>\n <li>\n Lactating or pregnant females</li>\n <li>\n Any condition that the investigator feels will result in an unfavorable outcome should the potential subject participate in the study</li>\n</ul>\n
      • primary_end_points<p>\n The primary study endpoint is the time to parasitaemia clearance from day 0 after treatment initiation. Parasitaemia clearance is defined as the parasitaemia disappearance at day 1, day 2 and up to day 28 after treatment</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The kombewa clinical research is well equiped to run phase I to phase IV clinical trials. It has fully equiped clinical laboratory with hematology, biochemestry, microbiology and microcopy departments. The center also has a fully equiped clinical research pharmacy with an emergency room and upto date emergency kits, consultation rooms, nursing station, document storage area, consenting rooms and briefing hall.</p>\n<p>\n The study has 7 investigators, 1 clinical research coordinator, 7 nurses, 5 laboratory personnel, 1 internal quality control personnel, 5 clinical officers, 1 pharmacyst and 3 pharm techs</p>\n
      • other_details_explanation<p>\n The study is an investigator initiated efficacy study.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration42 days per partcipant
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKombewa Clinical Research Center
      • single_site_physical_addressOff Kisumu Bondo road opposite Kombewa District Hospital
      • single_site_contact_personDr Ben Andagalu
      • single_site_telephone+254716004851
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site118
      • total_participants_worldwide118
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBen
      • investigator1_middle_name
      • investigator1_family_nameAndagalu
      • investigator1_qualificationMD,MSc
      • investigator1_professional_address54-40100 Kisumu, Kenya
      • investigator1_telephone+254716004851
      • investigator1_emailBen.Andagalu@usamru-k.org
      • organisations_transferred_No
      • number_participants118
      • notification
      • approval_date14-07-2014
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-05-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-04-05 23:05:22
      • created2014-05-14 18:44:21
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id206
        • application_id296
        • given_nameBen
        • middle_name
        • family_nameAndagalu
        • qualificationMD, MSc
        • professional_address54-40100 Kisumu, Kenya
        • telephone+254716004851
        • emailBen.Andagalu@usamru-k.org
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
    • SiteDetail(array)
      • 0(array)
        • id255
        • application_id296
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id165
        • application_id296
        • sponsorDepartment of Emerging Infectious Diseases of the United States Army Medical Research Unit
        • sponsor_type(null)
        • contact_personCOL Roddney Coldren
        • address54-40100 Kisumu
        • telephone_number+254-20-272-9303
        • fax_number+254-20-271-4592
        • cell_number+254 (0)700 881955
        • email_addressrodney.coldren@usamru-k.org
        • created2014-05-15 09:34:01
        • modified2014-05-15 13:10:42
  • 1(array)
    • Application(array)
      • id981
      • user_id81
      • trial_status_id5
      • abstract_of_study<p>\n Snakebite affects over 5 million people each year, and over 100,000 per year die as a result. Children and young people bear the greatest burden, and the majority of bites occur in remote rural settings with limited access to medical services. The only available treatment is antivenom, an animal product produced through a process of exposing large mammals to repeated sublethal doses of snake venom. Antivenom has many shortcomings, including high cost, intravenous administration, high risk of adverse events and narrow species specificity. The venom of vipers predominantly consists of Snake Venom Metalloproteinases (SVMPs), which are zinc dependent enzymes. SVMPs cause blood vessel breakdown, consumption coagulopathy and skin necrosis. Pre-clinical research, including use of the same in vivo experiments that are the gold standard for assessing antivenom, have shown that metal chelators can potently inhibit the activity of viper venom, by deactivating SVMPs. Through systematic screening of a range of chelating agents, unithiol has been identified as the most promising chelating agent and needs further evaluation in clinical trials. As well as preventing skin damage and death in vivo, unithiol is a safe and well tolerated drug that has been is use as a treatment for heavy metal poisoning for many decades. We propose a phase I clinical trial to assess unithiol as a treatment for snakebite.</p>\n<p>\n The primary outcome will be to determine safety and tolerability of a dosing regimen that is relevant to snakebite. The pharmacokinetic and pharmacodynamic profile of unithiol will also be described. Healthy Kenyan volunteers will be invited to enroll from Kilili County. Volunteers will be randomized into dosing cohorts of 8. The first dosing cohort will receive 300 mg of oral unithiol, which is the dose normally used for heavy metal poisoning. With review of safety, single ascending dose escalations will be made with the aim of giving a maximum dose of 1,500 mg oral. A minimum of two further cohorts will receive intravenous doses of unithiol, as this route may be useful for rapidly achieving therapeutic levels. Following review of the emerging data, two cohorts will receive multiple doses of unithiol for up to 72 hours, which will be the anticipated regimen for snakebite treatment.Pharmacokinetic analysis will be undertaken to calculate the half-life, Cmax and to define the elimination of unithiol in the urine. Pharmacodynamic analysis will include application of a novel ex vivo assay for quantifying the inhibition of SVMP associated pathology.</p>\n
      • study_title<p>\n TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults)</p>\n
      • laymans_summary<p>\n <strong>What is the problem/background?</strong></p>\n<p>\n Every year 94,000 people die following a snakebite.  In Kilifi County Hospital alone, there have been 1,500 snakebites requiring hospital admission since 2007. The only treatment available (antivenom – a product made by repeatedly exposing mammals, such as horses, to sub-lethal doses of venom) is expensive and can cause allergic reactions. Many snake venoms require zinc to function. Drugs that stick to and remove zinc (‘chelators’, including unithiol) have been shown to deactivate these snake venoms in laboratory experiments.</p>\n<p>\n Unithiol is a treatment for heavy metal poisoning (such as arsenic or mercury poisoning) and has been in use as an established therapy for a number of decades. It is known to bind to zinc. This drug is available as an oral capsule as well as a solution for intravenous injection into the blood-stream. As far as we are aware, unithiol is not routinely available in Kenya, and it is not registered with the pharmacy and poisons board (PPB). For many years, safety data has been collected for unithiol elsewhere and overall it is a safe drug with minimal risk of serious side effects. When unithiol is used as a treatment for snakebite, laboratory experiments suggest that higher doses may be needed, compared to doses normally used for treating heavy metal poisoning.</p>\n<p>\n Unlike antivenom, unithiol is available as a capsule and could be stocked in rural clinics, which would reduce delays to accessing snakebite treatment. Unithiol has been used for the treatment of metal poisoning for many years and there is a reasonable amount of reassuring safety data.</p>\n<p>\n In this study, groups of healthy Kenyan people were given increasing amounts of unithiol and closely monitored to check if this is safe.</p>\n<p>\n <strong>What questions did we answer?</strong></p>\n<p>\n 1) Can higher oral doses of unithiol be safely given to healthy adult Kenyan voluneteers?</p>\n<p>\n 2) What are the drug levels of unithiol and how long are drug levels maintained after each dose?</p>\n<p>\n 3) Can a new method of measuring the activity of unithiol in blood samples, to inhibit the actions of venom, produce reliable results?</p>\n<p>\n <strong>What did this study tell us?</strong></p>\n<p>\n 1) Increased oral doses of unithiol were well tolerated and safe in this small group of healthy adult Kenyan volunteers.</p>\n<p>\n 2) Drug levels in the blood stream were were proportionally higher as the oral dose of unithiol was increased. At a higher dose (above 1,200 mg), the rate of gut absorption seemed to prevent blood levels from increasing any further, therefore, doses above this level are not recommended.</p>\n<p>\n 3) It was not possible to develop a reliable new method of measuring the activity of unithiol in blood to inhibit the actions of venom. Future studies to assess whether unithiol provides benefit in individuals with snakebite are a priority.</p>\n<p>\n <strong>What will happen next?</strong></p>\n<p>\n Future studies are being planned to test the increased oral dose developed in this study in people with snakebite. If unithiol were to demonstrate clinical benefit (such as reducing the risk of abnormal bleeding in snakebite patients) then it may be developed as a treatment that can routinely be given in community settings. This could reduce the time to treatment, reduce our reliance on antivenom, and ultimately reduce the burden of death and disability caused by snakebite.</p>\n
      • short_titleUnithiol Phase I
      • protocol_noECCT/21/03/05
      • version_no2
      • date_of_protocol05-11-2020
      • study_drugUnithiol
      • disease_conditionHealthy volunteers
      • 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_nameUnithiol
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressCGMRCCSC@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Mainga Hamaluba
      • declaration_date125-03-2021
      • declaration_principal_investigatorDr Michael Abouyannis
      • declaration_date225-03-2021
      • placebo_presentNo
      • study_objectives<p>\n Primary objective: to determine safety and tolerability of unithiol in healthy Kenyan adults.</p>\n<p>\n Secondary objective: to define the pharmacokinetic profile of unithiol in healthy Kenyan adults.</p>\n<p>\n Exploratory objective: To explore <em>ex vivo </em>efficacy of unithiol at varying doses to inhibit the pathogenic activity of <em>Echis ocellatus </em>and other venoms that rely on snake venom metalloproteinases</p>\n
      • principal_inclusion_criteria<p>\n • Capable of giving informed consent</p>\n<p>\n • Male or female</p>\n<p>\n • KHDSS resident</p>\n<p>\n • 18-64 years old (inclusive)</p>\n<p>\n • Body weight 50-120kg</p>\n<p>\n • In good health, as determined by the investigator following medical history, drug history, examination, vital signs, ECG and blood tests</p>\n<p>\n • Willing to be admitted to the in-patient facility for up to 5 days for dosing and intensive blood sampling</p>\n<p>\n • On effective contraception as defined by: Use of effective method of contraception for duration of study (women only). We will ask the female volunteers to come with their family planning records to verify. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).</p>\n
      • principal_exclusion_criteria<p>\n • Prescribed a concomitant medication other than paracetamol or an appropriate contraceptive, which in the opinion of the Investigator warrants exclusion.</p>\n<p>\n • Any significant current or past history of cardiovascular, respiratory, renal or hepatic disease.</p>\n<p>\n • Subjects who have taken any non-prescribed herbal medication or mineral supplement in the preceding 7 days, which in the opinion of the Investigator warrants exclusion.</p>\n<p>\n • Subject with clinically significant abnormal vital signs at screening</p>\n<p>\n • Abnormal laboratory findings deemed significant by the Investigator</p>\n<p>\n • Subjects who are pregnant or lactating</p>\n<p>\n • Decline pre-trial screening, including HIV testing</p>\n<p>\n • HIV positive subjects will be excluded from the trial and, if not already receiving appropriate clinic follow-up, would be referred to a government clinic for ongoing care</p>\n<p>\n • Subjects with asthma (due to possible risk of exacerbation with allergic type skin reactions to unithiol)</p>\n<p>\n • Subjects that have donated blood within the past 3 months</p>\n<p>\n • Subjects who in the opinion of the investigator should not participate</p>\n
      • primary_end_points<p>\n Primary objective: to determine safety and tolerability of unithiol in healthy Kenyan adults.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • 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_specifyUnithiol is a repurposed drug that is routinely in use for treating heavy metal poisoning. We are conducting a safety trial as at higher doses there is pre-clinical evidence to suggest that unithiol may inhibit snakebite envenoming.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The site has long standing experience in conducting clinical research with currently over 200 studies in clinical research including phase I - IV trials. KEMRI-CGMRC has close to 1000 employees and about a third of them are scientists. All clinical trial staff are trained in acute resuscitation and in the event of emergencies provisions are in place for resuscitation and ambulance transfer to the Intensive Care Unit at the Aga Khan Hospital, Mombasa. If participants require non-critical care they will be admitted to the general wards where KEMRI staff will also oversee their care. The following staff will be supporting this trial:</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Clinical officer - 1</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Nurses - 2</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Assistant Research Officer - 1</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Data Manager - 1</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Data Clerk - 1</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n All clinical staff are trained in basic life support and resuscitation facilities are available.</p>\n
      • other_details_explanation<p>\n The sponsor of the trial is the Liverpool School of Tropical Medicine. Since this therapeutic is being developed for use in a setting where snakebite is prevalent it is appropriate to conduct the trial in Kenya. Gains from this trial could lead top improvements in health outcomes in the study country.</p>\n
      • other_details_regulatory_notapproved<p>\n Nil. This trial is only being conducted in Kenya.</p>\n
      • other_details_regulatory_approved<p>\n Nil. This trial is only being conducted in Kenya.</p>\n
      • other_details_regulatory_rejected<p>\n Nil.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_duration18 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Wellcome Trust Research Programme
      • single_site_physical_addressHospital Grounds, Off Bofa Road, Kilifi, Kenya
      • single_site_contact_personMainga Hamaluba
      • single_site_telephone+254709983946
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteSingle site
      • total_participants_worldwide64
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • 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_nameNA
      • investigator1_middle_name
      • investigator1_family_nameNA
      • investigator1_qualificationNA
      • investigator1_professional_addressNA
      • investigator1_telephoneNA
      • investigator1_emailmabouyannis@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants64
      • notification<p>\n Nil</p>\n
      • approval_date07-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-07-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy approved by the experts
      • final_report<h3>\n Background</h3>\n<p>\n Viperidae snakes are responsible for many of the 94,000 deaths caused by snakebite envenoming each year. The most pathological venom component of this globally diverse family of snakes are the zinc-dependent snake venom metalloproteinase (SVMP) enzymes, which can be inhibited by the metal chelator, unithiol. A short-course oral regimen, readily available and rapidly deployed ahead of hospital admission is needed.</p>\n<p>\n  </p>\n<h3>\n Methods</h3>\n<p>\n This open-label, phase 1 clinical trial assessed the safety of single ascending oral, multiple ascending oral, and single ascending intravenous doses of unithiol in 64 healthy adult volunteers from Kilifi County, Kenya. The multiple dose stage was informed by an interim safety and pharmacokinetic analysis, and predefined target plasma concentrations. Plasma concentrations of unithiol were measured using high-performance liquid chromatography-mass spectrometry, and safety was described by full adverse event reporting.</p>\n<h3>\n  </h3>\n<h3>\n Findings</h3>\n<p>\n 175 individuals were screened, and 64 (median age 30 years, IQR 25-38 years) received the study drug. There were no dose limiting toxicities or serious adverse events. There were 61 solicited adverse events, 17 related unsolicited adverse events, and 53 laboratory adverse events, all of mild or moderate severity. The maximum oral dose of 1,500 mg was well tolerated and associated with the following pharmacokinetic parameters: C_max 15.6 µg/mL, T_max 3.0 hours, T_1/2 18.4 hours, and AUC_0-last 180.9 h.µg/mL.</p>\n<p>\n  </p>\n<h3>\n Interpretation</h3>\n<p>\n The phase 2 recommended dose (1,500 mg loading dose, followed by 900 mg doses at 6-hours and 24-hours) is safe, and has promising pharmacokinetic properties for clinical use. Unithiol is affordable, stable at room temperature, and has the potential to be given orally in remote rural clinics. Its further development for snakebite indication is warranted.</p>\n<p>\n  </p>\n
      • implication_results<p>\n The results of this phase 1 trial will not have a direct bearing on clinical practice. The objective of this study was to develop an oral dosing regimen of unithiol for use in a future phase 2 efficacy trial assessing this treatment in people with snakebite. If future clinical trials demonstrate efficacy, then the dose developed in this phase 1 clinical trial may be used in routine practice.</p>\n<p>\n Unithiol has many potantial advantages over the current standard of care for treating snakebite with antivenom. Unithiol is more affordable to manufacture, has lower toxicity, can be adminsitered orally, and is likely to have broader effiacy against diverse snake species. However, efficacy needs to be confirmed in future clinical trials before unithiol could be recommended for routine use.</p>\n
      • quantity_importedDimaval 250 mg DMPS-Na/5 ml Solution for injection Ampoules -32; Dimaval®(DMPS) 100 mg Hard Capsule-405; Dimaval®(DMPS) 100 mg Hard Capsule-640.
      • quantity_dispensedDimaval 250 mg DMPS-Na/5 ml Solution for injection Ampoules-26; Dimaval®(DMPS) 100 mg Hard Capsule-312, Dimaval®(DMPS) 100 mg Hard Capsule-624
      • quantity_destroyedDimaval 250 mg DMPS-Na/5 ml Solution for injection Ampoules-6; Dimaval®(DMPS) 100 mg Hard Capsule- 93; Dimaval®(DMPS) 100 mg Hard Capsule-16
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2025-03-25 11:25:47
      • created2021-03-01 13:52:34
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id624
        • application_id981
        • given_nameMichael
        • middle_name
        • family_nameAbouyannis
        • qualificationMBChB
        • professional_addressP.O.Box 230, Kilifi 80108, Kenya
        • telephone+254727048061
        • emailmabouyannis@kemri-wellcome.org
        • created2021-03-01 14:10:43
        • modified2021-07-09 11:35:36
      • 1(array)
        • id625
        • application_id981
        • given_nameMainga Patience Mayeso
        • middle_name
        • family_nameHamaluba
        • qualificationMBChB MRCPCH MD
        • professional_addressP.O.Box 230, Kilifi 80108, Kenya
        • telephone(+254) 795 3204 22
        • emailMHamaluba@kemri-wellcome.org
        • created2021-03-01 14:18:31
        • modified2021-07-09 11:35:36
    • SiteDetail(array)
      • 0(array)
        • id858
        • application_id981
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-03-01 14:10:43
        • modified2021-07-09 11:35:36
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id481
        • application_id981
        • sponsorLiverpool School of Tropical Medicine
        • sponsor_typeResearch Institution
        • contact_person
        • addressPembroke St, Liverpool L3 5QA, UK
        • telephone_number+44(0)151 705 3100
        • fax_number
        • cell_number+44(0)151 705 3100
        • email_addresslindsay.troughton@lstmed.ac.uk
        • created2021-03-01 14:10:43
        • modified2021-07-09 11:35:36
  • 2(array)
    • Application(array)
      • id1318
      • user_id855
      • trial_status_id4
      • abstract_of_study<p>\n <strong>Title: </strong></p>\n<p>\n Use of Continuous glucose monitoring devices among Type 1 diabetes patients<ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-18T14:42\"> followed up in </ins> <ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-18T14:42\">CDiC clinics in Machakos, Nairobi and Kiambu Counties</ins> in Kenya: A three-arm pragmatic study on effectiveness, feasibility, acceptability, and cost.</p>\n<p>\n <strong>Background:</strong></p>\n<p>\n Diabetes mellitus is a significant health concern, and self-monitoring of blood glucose (SMBG) can be challenging for individuals with diabetes. Continuous glucose monitoring (CGM) devices offer a minimally invasive and continuous glucose measurement solution. However, their effectiveness, feasibility, acceptability, and cost in low- and middle-income countries (LMICs) remain uncertain.</p>\n<p>\n <strong>Objectives: </strong></p>\n<p>\n This study aims to evaluate the impact of continuous and intermittent CGM use compared to standard of care in type 1 diabetes patients in Kenya. Secondary objectives include assessing glucose stability, diabetes-related complications, quality of life, acceptability, and feasibility. Additionally, <ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T11:24\">Haemoglobin A1C (</ins>HbA1c<ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T11:24\">)</ins> measurement methods will be compared.</p>\n<p>\n <strong>Methods: </strong></p>\n<p>\n A three-arm pragmatic randomized controlled study will be conducted in three sites within the Changing Diabetes in Children program in Kenya. Arm 1 will use CGM continuously, Arm 2 will use CGM intermittently (two weeks every three months), and Arm 3 will receive standard of care. The study population includes individuals with type 1 diabetes attending DMI Centre, Machakos and Kiambu Level five Referral Hospitals. Recipients of care, caregivers, and healthcare providers will participate in the study.</p>\n<p>\n <strong>Outcomes: </strong></p>\n<p>\n The primary outcomes include changes in HbA1c levels for each arm. Secondary outcomes comprise glucose concentration variability, clinic visits, hospitalizations due to diabetes complications, quality of life, and cost. Exploratory outcomes will compare HbA1c measurements from point-of-care testing devices and venous blood tests.</p>\n<p>\n <strong>Study Duration: </strong></p>\n<p>\n November 2023 to January 2025.</p>\n<p>\n <strong>Summary Budget: </strong></p>\n<p>\n USD 129,990.</p>\n<p>\n <strong>Conclusion: </strong></p>\n<p>\n This three-arm pragmatic study will provide critical insights into the effectiveness, feasibility, acceptability, and cost of continuous and intermittent CGM use in managing type 1 diabetes in Kenya. The findings will inform clinical models for integrating CGMs into diabetes management, particularly in LMICs, and contribute to improving diabetes care and outcomes.</p>\n<p>\n  </p>\n
      • study_title<p>\n Use of Continuous glucose monitoring devices among Type 1 diabetes patients followed up in CDiC clinics in Machakos, Nairobi and Kiambu counties in Kenya: A three-arm pragmatic study on effectiveness, feasibility, acceptability, and cost</p>\n
      • laymans_summary<p>\n Diabetes is a lifelong health condition that affects many people around the world. People with diabetes need to check their blood sugar levels regularly to manage their health. The usual way to do this is checking the sugar in blood from a finger prick, several times a day, which can be painful and bothersome. This method also only gives a limited view of blood sugar levels, which could lead to missing important changes.</p>\n<p>\n The Kenya Diabetes and Information Centre and FIND is exploring a better way to monitor blood sugar levels using a device called a continuous glucose monitor (CGM). CGMs are small devices that can measure blood sugar levels continuously over a week or two. They use a tiny needle inserted into the arm or abdomen, so people can avoid frequent finger pricks. CGMs provide a detailed view of blood sugar levels throughout the day, helping people make better decisions about their treatment and lifestyle.</p>\n<p>\n In some places, CGMs are widely available and covered by healthcare systems, but in low-income countries like Kenya, they are not commonly used because of its cost and limited access. Little is known about how effective, practical, and affordable CGMs are in these countries. We want to find out if using CGMs sometimes (intermittently) could still be beneficial for people who cannot use them all the time due to cost.</p>\n<p>\n To do this, we are conducting a study that will follow up three groups; one group using CGMs all the time, one using CGMs sometimes, and a control group receiving standard diabetes care without CGMs.</p>\n<p>\n The main goal is to see how CGMs affect blood sugar management compared to standard care. We will also look at other factors, such as how stable blood sugar levels are, how often people need to go to the hospital for diabetes-related issues, and how CGMs impact the quality of life for those using them and their caregivers. Additionally, we will seek to know if healthcare providers and patients find CGMs acceptable and feasible for regular use.</p>\n<p>\n By the end of the study, we hope to understand if CGMs can be a helpful tool for managing diabetes in Kenya and similar places with limited resources. This knowledge could improve diabetes care and make life better for people living with type 1 diabetes in these areas.</p>\n<p>\n  </p>\n
      • short_titleACCEDE OR Study
      • protocol_noECCT/23/10/04
      • version_noV4
      • date_of_protocol01-09-2023
      • study_drugNA
      • disease_conditionDIABETES
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameContinuous Glucose Monitors
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdkatambo@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_applicantDr.Daniel Katambo, +254757417404, dkatambo@gmail.com
      • declaration_date113-10-2023
      • declaration_principal_investigatorDr. Daniel Katambo
      • declaration_date213-10-2023
      • placebo_presentNo
      • study_objectives<p style=\"margin-left: 36pt;\">\n  </p>\n<p>\n 1. To assess the cost of continuous and intermittent CGM from a user and provider perspective</p>\n<p>\n 2.To assess the acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care & care givers perspective</p>\n<p>\n 3.To assess the impact of continuous and intermittent CGM use on the stability of blood glucose concentrations related to diabetes in people living with type 1 diabetes</p>\n<p>\n 4.To assess the impact of continuous and intermittent CGM use on unplanned visits to outpatient clinics and/or hospital related to diabetes complications.</p>\n<p>\n 5.To assess the impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable</p>\n
      • principal_inclusion_criteria<p>\n <strong><ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T12:05\">Inclusion Criteria - For Patients</ins></strong></p>\n<p>\n Persons living with type 1 diabetes with at least 1 measurement of HbA1c  ≥10% or >86mmol/mol) within 18 months preceding the study and no HbA1c <8%  or <64mm</p>\n<p>\n <strong><ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T12:05\">Inclusion Criteria - For care givers</ins></strong></p>\n<ul>\n <li>\n Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study if the child/adolescent to whom the person is a care giver is enrolled in the study.</li>\n</ul>\n<p>\n <strong><ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T12:06\">Inclusion Criteria for Healthcare providers </ins></strong></p>\n<ul>\n <li>\n Healthcare providers are eligible for inclusion in the study be included in the study only if all the following inclusion criteria applyealthcare provider at the study sites are engaged in provision of diabetes care related to the study.</li>\n</ul>\n<p>\n  </p>\n<p>\n mol/mol over the past nine (9) months</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li>\n People living with type 1 diabetes but are under 4 years of age.</li>\n <li>\n People diagnosed with Type 1 diabetes within the last 2 years.</li>\n <li>\n People who have used a CGM in the last 18 months preceding the study/ enrollment</li>\n <li>\n People living with type 2 diabetes.</li>\n <li>\n Known pregnancy at the time of study enrolment.</li>\n</ol>\n<p>\n  </p>\n
      • primary_end_points<ol>\n <li>\n Estimates of coefficient of variation (CV) for glucose concentrations with 95% confidence intervals, Time in Range (TIR), Time Below Range (TBR), and Time Above Range (TAR) (percentage of time per day and as estimated hours and minutes per day with their 95% confidence intervals) for participants who received the CGM treatments.</li>\n <li>\n Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations.</li>\n <li>\n Mixed methods QoL A: survey results including EQ-5D-Y/EQ-5D and Diabetes distress scores at baseline, midpoint, end point of intervention and endpoint of study. B: Qualitative methods<ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T11:22\">, focused group discussions</ins> (FGD) among recipients of care and their caregivers</li>\n <li>\n Mixed methods: Feasibility will be assessed based on Arm 1 and Arm 2 adherence to protocol in terms of CGM use. Acceptability scores from the GMSS tool at baseline, midline, and end of the intervention period among recipients of care, and results from an acceptability survey from baseline, midline, and end line among recipients of care and their caregivers. Qualitative methods<del cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T11:23\">;</del><ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T11:23\">,</ins><ins cite=\"mailto:Elena%20Marban\" datetime=\"2023-08-20T11:22\"> semi-structured interviews</ins> (SSI) among health care providers involved in clinical care at the study sites.</li>\n <li>\n Costing surveys which capture direct and indirect costs at each follow-up visit among recipients of care, their caregivers and healthcare provider, and at end point of study, modelling over time horizon may be explored.  </li>\n</ol>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyEffectiveness, feasibility, acceptability, and cost of continuous glucose monitoring device
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyN/A
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Machakos Level 5 Hospital - Diabetes Centre of Excellence</strong></p>\n<p>\n Study site investigator/ Clinical officer - Lucy Mwende, Diploma in Clinical medicine. 14 years experience in clinical practice</p>\n<p>\n Pharmacist - Dr. Chirag Ramesh Patel</p>\n<p>\n Nurse - Christine Muthoka</p>\n<p>\n <strong>Thika Level 5 Hospital - Diabetes Clinic</strong></p>\n<p>\n Study Site investigator/ Diabetes Nurse educator - Joyce Mbugua, Kenya Enrolled Nurse. 28 years experience in nursing</p>\n<p>\n Paediatric endocrinologist - Dr. Bernadette Lusweti</p>\n<p>\n <strong>Kenya Diabetes Management and Information Centre</strong></p>\n<p>\n Study Site Investigator/ Clinical officer - Eunice Munyiri, Diploma in clinical medicine and surgery. 4 years experience</p>\n<p>\n Nutritionist -Hilda Wanjiku</p>\n<p>\n Nurse educator - Marvin Kimani</p>\n<p>\n  </p>\n<p>\n STUDY PI -Dr. Daniel Katambo, MbCHB,MPH,MRCP. </p>\n<p>\n CO Investigator - Joan Kimetto, Bsc. Microbiology, MPH. 13 years experience in project management</p>\n<p>\n Data manager -To be engaged</p>\n<p>\n Research Assistants - To be employed</p>\n
      • other_details_explanation<p>\n DMI, the applying institution, is a Kenyan based institution.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n AMREF ESRC  - Approval granted on 11th September 2023, Approval number ESRC P1512/2023.</p>\n<p>\n There are 3 sites under this study, all in Kenya.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration15 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorSMBG
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site82
      • total_participants_worldwide286
      • 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_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDaniel
      • investigator1_middle_nameKatambo
      • investigator1_family_nameKiningu
      • investigator1_qualificationMBCHB,MPH,MRCP
      • investigator1_professional_addressP.O Box 45099, 00100 - GPO Nairobi
      • investigator1_telephone+254 757 417 404
      • investigator1_emaildkatambo@gmail.com
      • organisations_transferred_Yes
      • number_participants286
      • notification
      • approval_date19-02-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-11-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments 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)
      • modified2024-10-24 12:20:48
      • created2023-09-13 13:03:30
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id965
        • application_id1318
        • given_nameDaniel
        • middle_nameKatambo
        • family_nameKiningu
        • qualificationMBCHB,MPH,MRCP
        • professional_addressP.O Box 45099, 00100 - GPO Nairobi
        • telephone+254 757 417 404
        • emaildkatambo@gmail.com
        • created2023-09-14 14:25:23
        • modified2023-11-15 04:59:01
    • SiteDetail(array)
      • 0(array)
        • id1591
        • application_id1318
        • county_id16
        • site_nameMachakos Level 5 Hospital
        • physical_addressMachakos Town, Next to bus stage
        • contact_details+254 726 641 532 P.O. Box 19 90100, Machakos
        • contact_personLucy Mwende
        • site_capacity(null)
        • misc(null)
        • created2023-09-14 14:25:23
        • modified2023-11-15 04:59:01
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 1(array)
        • id1592
        • application_id1318
        • county_id22
        • site_nameThika Level 5 Hospital
        • physical_addressGeneral Kago Road, Kamenu, Thika Town, Kiambu Kenya
        • contact_details+254 714 391 434
        • contact_personJoyce Mbugua
        • site_capacity(null)
        • misc(null)
        • created2023-09-14 16:48:16
        • modified2023-11-15 04:59:01
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 2(array)
        • id1593
        • application_id1318
        • county_id16
        • site_nameKenya Diabetes Management and Information Centre
        • physical_addressJadala Place , Ngong lane Off Ngong road
        • contact_detailsTel: +254 702 341 011, P.O. Box 45099-00100
        • contact_personEunice Munyiri
        • site_capacity(null)
        • misc(null)
        • created2023-09-14 16:48:16
        • modified2023-11-15 04:59:01
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
    • Sponsor(array)
      • 0(array)
        • id693
        • application_id1318
        • sponsorFIND
        • sponsor_typeOthers
        • contact_personCathy Haldane
        • addressCampus Biotech, Chemin des Mines 9, 1202 Geneva, Switzerland
        • telephone_number+4122 710 05 90
        • fax_number
        • cell_number+27 82 372 6496
        • email_addresscathy.haldane@finddx.org
        • created2023-09-14 14:25:23
        • modified2023-11-15 04:59:01
  • 3(array)
    • Application(array)
      • id1046
      • user_id501
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong><u>Objectives</u></strong></p>\n<p>\n Primary Aim: To validate the functionality of Chloe SED, a novel, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a single-blind block randomized controlled clinical trial.  Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.</p>\n<p>\n  </p>\n<p>\n Secondary Aims:</p>\n<ol>\n <li>\n To assess safety of the syringe extension device via data collection on adverse outcomes.</li>\n <li>\n To assess provider’s experiences and opinions regarding use of the syringe extension device compared with the standard spinal needle administered block.</li>\n <li>\n To gather feedback on device design and improve upon the current model.</li>\n <li>\n To understand the acceptability and feasibility of device use and testing in western Kenya, including acceptance of the study population of randomization and blinding.</li>\n <li>\n To establish and strengthen research collaborations with the UIC School of Public Health and with community partners at Nyanza Reproductive Health Society in Kenya. These partnerships will be critical in further device testing, and for development of new future women’s health innovations.</li>\n <li>\n To assess patients’ experiences and preferences during MVA</li>\n</ol>\n
      • study_title<p>\n Validation of Chloe SED, a reusable, low-cost syringe extension device for the provision of paracervical analgesia during gynecologic procedures </p>\n
      • laymans_summary<p>\n In many rural clinics providing women’s health services, paracervical block is impossible to perform due to the high cost of necessary tools (spinal needle, needle extender).  In these situations, women undergo manual vacuum aspiration (MVA) and other gynecologic procedures without paracervical analgesia.  We have developed a low-cost, reusable syringe extension device for the provision of paracervical analgesia during MVA.  Our initial pilot study of the device revealed that in a small sample size of 60, it is safe and non-inferior in efficacy to the standard spinal needle which is the current gold standard tool in administration of paracervical block.  We propose to further validate functionality of the device and collect user feedback from women’s health providers and patients at two sites in Western, Kenya.</p>\n
      • short_titleValidation of Chloe SED
      • protocol_noECCT/21/10/03
      • version_no1
      • date_of_protocol11-08-2021
      • study_drugChloe SED, a syringe extension device
      • disease_conditionPain during manual vacuum aspiration (MVA)
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameChloe SED
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgwerso@yahoo.co.uk
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_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_applicantStephen Gwer
      • declaration_date112-10-2021
      • declaration_principal_investigatorStephen Gwer
      • declaration_date212-10-2021
      • placebo_presentNo
      • study_objectives<p>\n <strong><u>Objectives</u></strong></p>\n<p>\n Primary Aim: To validate the functionality of Chloe SED, a novel, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a single-blind block randomized controlled clinical trial.  Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.</p>\n<p>\n  </p>\n<p>\n Secondary Aims:</p>\n<ol>\n <li>\n To assess safety of the syringe extension device via data collection on adverse outcomes.</li>\n <li>\n To assess provider’s experiences and opinions regarding use of the syringe extension device compared with the standard spinal needle administered block.</li>\n <li>\n To gather feedback on device design and improve upon the current model.</li>\n <li>\n To understand the acceptability and feasibility of device use and testing in western Kenya, including acceptance of the study population of randomization and blinding.</li>\n <li>\n To establish and strengthen research collaborations with the UIC School of Public Health and with community partners at Nyanza Reproductive Health Society in Kenya. These partnerships will be critical in further device testing, and for development of new future women’s health innovations.</li>\n <li>\n To assess patients’ experiences and preferences during MVA</li>\n</ol>\n
      • principal_inclusion_criteria<p>\n <strong>Inclusion criteria for RCT:</strong></p>\n<p style=\"margin-left:.25in;\">\n ●      Women’s health providers providing MVA services at the 2 study sites.</p>\n<p style=\"margin-left:.25in;\">\n ●      Female patients receiving MVA at the two study sites.  These women will be determined clinically eligible for MVA treatment by a licensed Kenyan Medical Officer or Clinical Officer who has evaluated them.</p>\n<p style=\"margin-left:.25in;\">\n ●      Ability to consent and understand that participation in the study involves potential use of a new device during the planned MVA.</p>\n<p style=\"margin-left:.25in;\">\n ●      Age 18 years or greater.</p>\n<p style=\"margin-left:.25in;\">\n  </p>\n<p style=\"margin-left:.25in;\">\n <strong>Inclusion criteria for the focused group discussion of Kenyan women:</strong></p>\n<p>\n ·       Kenyan woman with ability to consent.</p>\n<p>\n ·       Age 18 years or greater.</p>\n<p>\n ·       Have previously had MVA (by patient report or hospital records)</p>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion criteria for RCT:</strong></p>\n<p>\n Males will be excluded from the patient population as men do not receive MVA services.  Male MVA providers will not be excluded from the provider population.<strong>  Persons under the age of 18 will be excluded.  Any member of the research team (including PI and Co-Is) who is also a women’s health provider will be excluded so as to avoid bias.  </strong>There is no limitation based on race, tribe, religion or sexual orientation in the study for any patients or providers who meet inclusion criteria.  There are no exclusions for patients based on language.  </p>\n<p>\n  </p>\n<p>\n Contraindications to lidocaine or patients with increased risks to MVA procedure (as determined by PPB in the initial pilot study) which include the following:</p>\n<p>\n ·      Known or suspected hypersensitivity to lidocaine</p>\n<p>\n ·      Skin infection adjacent to proposed site of injection (for MVA this would include uterine and cervical infection)</p>\n<p>\n ·      Concomitant anticoagulant therapy or an abnormal bleeding tendency</p>\n<p>\n ·      Severe anemia or heart disease.  Severe anemia will be defined as per the WHO, as anemia associated with symptoms of fatigue, weakness, dizziness, and drowsiness or known haemoglobin concentration less than 7.0 g/dL</p>\n<p>\n  </p>\n<p>\n <strong>Exclusion criteria for focused group discussion of MVA providers:</strong></p>\n<p>\n Age less than 18 years.  There is no limitation based on religion, race, tribe, or sexual orientation in the study for any MVA providers who meet inclusion criteria.  There are no exclusions for MVA providers based on language.</p>\n
      • primary_end_points<p>\n The primary end point will be pain score as assessed by an 11 point Visual Assessment Scale (VAS) duing uterine evacuation. </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-family: Calibri, sans-serif; font-size: 12pt; color: black;\">The study population will include women’s health providers who perform MVA and patients requiring manual vacuum aspiration (MVA) at two clinical sites in Kisumu, Kenya: Jaramogi Oginga Odinga Teaching and Referral Hospital, Kisii Teaching and Referral Hospital.  The study team met with the regional directors at each of the sites and confirmed willingness of each site to participate in the study (letters of support included).  Clinical volume and number of MVA providers at each site were confirmed to ensure an adequate number of potential study participants for recruitment within the study period.  Average clinical volume between the five sites is 400 MVA procedures per month with approximately 30 MVA providers available for potential study recruitment.</span></p>\n<p class=\"Body\" style=\"margin: 0in; line-height: 16.866666793823242px; font-size: 11pt; font-family: Arial, sans-serif; color: black; border: none;\">\n <span style=\"font-size: 12pt; line-height: 18.399999618530273px; font-family: Calibri, sans-serif;\"> </span></p>\n<p class=\"Body\" style=\"margin: 0in; line-height: 16.866666793823242px; font-size: 11pt; font-family: Arial, sans-serif; color: black; border: none;\">\n <span style=\"font-size: 12pt; line-height: 18.399999618530273px; font-family: Calibri, sans-serif;\">Jaramogi Oginga Odinga Teaching and Referral Hospital has a maternity complex with 60 beds. MVA providers at this facility include medical officers (MO) and clinical officers (CO).  Other providers staffing the ward including Ob/Gyn physicians, residents, and nursing staff.  There is a procedure room available for MVA procedures and an operating theatre also available.   <o:p></o:p></span><span style=\"font-family: Calibri, sans-serif; font-size: 12pt;\">Kisii Teaching and Referral Hospital has a maternity complex with 68 beds.  A procedure room is available for MVA procedures.  MVA procedures are completed by MOs and COs.  All sites have adequate staff and equipment to carry out the study.  </span></p>\n
      • other_details_explanation<p>\n Kenya is the country of origin of the applicant. </p>\n
      • other_details_regulatory_notapproved<p>\n University of Illinois at Chicago, pending - submitted 14th September 2021</p>\n
      • other_details_regulatory_approved<p>\n JOOTRH ERC - approved 26th August 2021</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable </p>\n
      • other_details_regulatory_halted<p>\n Not applicable </p>\n
      • estimated_duration12 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorSpinal needle
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteMinimum 10 patients and 1 provider per site, maximum 200 patients and 20 providers
      • total_participants_worldwide210 patients
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameStephen
      • investigator1_middle_name
      • investigator1_family_nameGwer
      • investigator1_qualificationChair of Obstetrics and Gynecology, Maseno University
      • investigator1_professional_addressDepartment of Obstetrics and Gynecology, School of Medicine, Maseno University, Private Bag, Maseno
      • investigator1_telephone+254 772 657163
      • investigator1_emailgwerso@gmail.com
      • organisations_transferred_No
      • number_participants210 patients and 21 providers
      • notification
      • approval_date29-04-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-10-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe comments from reviewers 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)
      • modified2023-04-20 15:15:48
      • created2021-08-11 21:36:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id708
        • application_id1046
        • given_nameStephen
        • middle_name
        • family_nameGwer
        • qualificationChair of Obstetrics and Gynecology, Maseno University
        • professional_addressDepartment of Obstetrics and Gynecology, School of Medicine, Maseno University, Private Bag, Maseno
        • telephone+254 772 657163
        • emailgwerso@gmail.com
        • created2021-08-11 22:07:09
        • modified2021-10-13 00:59:49
    • SiteDetail(array)
      • 0(array)
        • id1091
        • application_id1046
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)
        • physical_addressKisumu Kakamega highway
        • contact_detailsP.O. Box 849 - 40100 Kisumu Tel +254-57-2020801
        • contact_personDr. Dedan Ongong\'a
        • site_capacity(null)
        • misc(null)
        • created2021-08-11 22:07:09
        • modified2021-10-13 00:59:49
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1120
        • application_id1046
        • county_id45
        • site_nameKisii Teaching & Referral Hospital (KTRH)
        • physical_addressKisii Town
        • contact_detailsP.O. Box 92 - 40200 Kisii +254-58-31310
        • contact_personDr. Stanley Ratemo
        • site_capacity(null)
        • misc(null)
        • created2021-09-08 16:57:38
        • modified2021-10-13 00:59:49
        • County(array)
          • id45
          • county_nameKisii
          • created2012-06-15 10:27:25
          • modified2012-06-15 10:27:25
    • Sponsor(array)
      • 0(array)
        • id531
        • application_id1046
        • sponsorGrand Challenges Canada
        • sponsor_typeOthers
        • contact_personSonali Patel
        • addressMaRS Centre, West Tower Canada, 661 University Avenue, Suite 1720 Toronto ON M5G 1M1
        • telephone_number4166736568
        • fax_number
        • cell_number4166736568
        • email_addresssonali.patel@grandchallenges.ca
        • created2021-08-11 22:07:09
        • modified2021-10-13 00:59:49
  • 4(array)
    • Application(array)
      • id505
      • user_id613
      • trial_status_id1
      • abstract_of_study<p style=\"margin-left:.5in;\">\n The ability of the HIV virus to establish latency in the infected individual is a major obstacle to curing the infection. HIV latency in long lived cells, particularly resting memory CD4+ T cells, promotes viral quiescence, which renders latently infected CD4+ memory cells non-susceptible to antiretroviral drugs or HIV-specific immunity. A case of prolonged HIV remission was reported in a child who was treated with three drug ART by 31 hours of life for high-risk HIV-exposure from untreated maternal infection. Longitudinal follow-up revealed eventual return of viremia at 46 months of age after being off ART for nearly 2.3 years. The re-emergence of viremia in this child provides further support that viral remission is achievable in perinatal infection through time-limited very early ART, although the exact timing of ART initiation and duration of ART required to achieve cure is unknown and will be studied in P1115. This study (P1115) will address the hypothesis that very early therapy in HIV-infected neonates substantially limits the establishment of HIV reservoirs to permit long-term control of HIV replication off ART, leading to HIV remission. This protocol is designed to focus on the effect of starting ART within the first 48 hours of life on likelihood of achieving HIV remission in <em>in utero </em>infection. The primary objective is to assess HIV remission among HIV-infected neonates who initiate ART within 48 hours of birth. Infants and their mothers will be enrolled in two cohorts; Cohort 1 being infants≤ 48 hours of age at high risk for HIV infection (i.e. born to a mother with confirmed or presumed HIV infection and mother did not receive ARVs during the current pregnancy or mother first identified as HIV-infected in labor or postpartum). Cohort 2 will be infants ≤ 10 days of age who are HIV-infected and ART-started within the first 48 hours of life. The study consists of four steps: Step 1 (evaluation and initial treatment of high-risk infants), Step 2 (management of subjects with confirmed HIV infection), HIV-infected infants who meet defined eligibility criteria will undergo ART cessation at or after Step 2 Week 96 <strong>will enter Step 3 and undergo ART cessation, as per protocol defined criteria, </strong>and remain off ART unless there is a confirmed HIV RNA rebound to ≥ LOD.  After step 3, participants who develop viral rebound <strong>or meet other Step 4 inclusion criteria </strong>will enter  Step 4 (ART re-initiation for those with confirmed viral rebound at step 3).</p>\n<p>\n  </p>\n
      • study_title<p>\n Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study</p>\n
      • laymans_summary<p>\n The main purpose of this study is to find out if starting anti-HIV medicines (ARVs) within 48 hours of birth can make it possible for babies who are infected with HIV to control HIV so well that HIV cannot be detected in their blood. As of now, when children with HIV start taking ARVs, they usually need to keep taking them for life. For newborn babies who start ARVs very soon after birth, it might be possible to later stop taking ARVs for a prolonged period of time and still stay healthy.  This has only been seen in one baby so far. That child started ARVs soon after birth, then stopped ARVs, and was able to stay healthy, with no HIV detected in the blood, for more than two years.  About 27 months after stopping ARVs, HIV was detected in this child’s blood and the child restarted ARVs.  The amount of HIV in the child’s blood quickly dropped and the child has remained healthy.  This study is being done to find out if this can be seen in other babies who start ARVs very soon after birth.  This study is also looking at the levels of ARVs that are safe and work well for babies this young.</p>\n<p>\n Kericho site plan to enroll upto 60 mothers and their infants into this study.</p>\n<p>\n  </p>\n
      • short_titleP1115
      • protocol_noECCT/16/06/01
      • version_noVersion 1.0
      • date_of_protocol12-03-2014
      • study_drugNevirapine, Lopinavir/r, Abacavir, Zidovudine
      • 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_nameAnti Retrovirals
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjosphat.kosgei@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • 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_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Josphat Kosgei
      • declaration_date123-06-2016
      • declaration_principal_investigatorDr Fredrick Sawe
      • declaration_date223-06-2016
      • placebo_presentNo
      • study_objectives<div>\n Primary Objective</div>\n<div>\n 2.1.1 To assess HIV remission among neonates with in utero HIV infection who initiate early intensive therapy within 48 hours of birth. HIV remission is defined as having no confirmed plasma HIV-1 RNA ≥ LOD through 48 weeks of ART cessation.</div>\n<div>\n 2.2 Secondary Objectives</div>\n<div>\n 2.2.1 To assess the safety and tolerability of early intensive therapy regimens in neonates and young infants.</div>\n<div>\n 2.2.2 To assess, by regimen (Regimen 1L separately from Regimens 2R+2RV combined), the proportion of infants receiving early intensive therapy who achieve viral suppression (plasma HIV-1 RNA <lod) at=\"\" div=\"\" week=\"\">\n <div>\n 2.2.3 To assess, by regimen (Regimen 1L separately from Regimens 2R+2RV combined), the proportion of infants receiving early intensive therapy who meet virologic and immunologic criteria for treatment cessation.</div>\n <div>\n 2.2.4 To assess, by regimen (Regimen 1L separately from Regimens 2R+2RV combined), the relationship between time to achieve confirmed viral suppression (plasma HIV-1 RNA < LOD) and meeting the virologic and immunologic criteria for treatment cessation.</div>\n <div>\n 2.2.5 To assess the extent of HIV persistence in infants who achieve HIV remission.</div>\n <div>\n 2.2.6 To evaluate immune activation and host and viral determinants, including maternal factors and HIV-specific immune responses, associated with HIV remission.</div>\n <div>\n 2.2.7 To assess biomarkers of HIV reservoir size among infants receiving early intensive therapy (including but not limited to proviral HIV DNA load and HIV serostatus).</div>\n <div>\n 2.2.8 To assess resistance to ARVs included in the study regimens and to VRC01.</div>\n <div>\n 2.2.9 To describe RAL and VRC01 exposures in neonates and young infants.</div>\n </lod)></div>\n
      • principal_inclusion_criteria<p>\n Stipulated on pages 27-31 of the main protocol.</p>\n
      • principal_exclusion_criteria<p>\n Stipulated on page 31 of the main protocol.</p>\n
      • primary_end_points<p>\n Section 8.226 of the Main Protocol attached, page 56.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study1
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The site capacity is detailed in the attached SSA page 19-20.</p>\n
      • other_details_explanation<p>\n Not Applicable.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU. Date: 03 Aug 2015.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n None.</p>\n
      • estimated_duration9 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI WALTER REED PROJECT KERICHO
      • single_site_physical_addressOFF HOSPITAL ROAD
      • single_site_contact_personDR JOSPHAT KOSGEI
      • single_site_telephone0729 110 122
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states13
      • number_of_sites
      • multi_country_listKenya, USA, Malawi, Uganda, Thailand, India, Argentina, Brazil, South Africa, Zambia, Zimbabwe, Tanzania, Mozambique.
      • data_monitoring_committeeYes
      • total_enrolment_per_site60
      • total_participants_worldwide472
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDavid
      • investigator1_middle_name
      • investigator1_family_nameWekulo
      • investigator1_qualificationBSc Nursing
      • investigator1_professional_addressKEMRI Walter Reed Project Kericho
      • investigator1_telephone0729 110 146
      • investigator1_emaildavid.wekulo@usamru-k.org
      • organisations_transferred_No
      • number_participants60
      • notification
      • approval_date25-07-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-27 11:57:33
      • created2016-06-20 09:06:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id331
        • application_id505
        • given_nameFredrick
        • middle_name
        • family_nameSawe
        • qualificationMBChB, MMED
        • professional_addressKEMRI Walter Reed Project Kericho
        • telephone0703 247 902
        • emailfredrick.sawe@usamru-k.org
        • created2016-06-20 09:12:58
        • modified2020-05-27 12:22:44
    • SiteDetail(array)
      • 0(array)
        • id395
        • application_id505
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-06-20 09:12:58
        • modified2020-05-27 12:22:44
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id263
        • application_id505
        • sponsorThe US National Institute of Allergy and Infectious Diseases (NIAID)
        • sponsor_typeResearch Institution
        • contact_personYvonne Bryson, M.D.
        • address10833 Le Conte Ave. MDCC 22-442 Los Angeles, CA 90095-1752
        • telephone_numberPhone: 310-825-5235
        • fax_number
        • cell_numberPhone: 310-825-5235
        • email_addressybryson@mednet.ucla.edu
        • created2016-06-20 09:12:58
        • modified2020-05-27 12:22:44
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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