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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id389
      • user_id263
      • trial_status_id5
      • abstract_of_study<p>\n The trial is being conducted as an effectiveness trial with the objective of the experimental intervention being registered for the indication “prevention of postpartum haemorrhage” by drug regulatory authorities if it is shown to be non-inferior or superior to the gold standard control, oxytocin. For this purpose a primary endpoint of blood loss 500 mL or more or use of additional uterotonics is considered appropriate. For the purpose of evaluating clinical effectiveness and for inclusion of the experimental intervention in future WHO guidelines and the Model List of Essential Medicines, the more substantive endpoint of blood loss 1000 mL or more is considered appropriate. The blood loss of 1000 mL or more was considered as one of the three critical endpoints (together with blood transfusion and maternal death) for the earlier 2007 WHO recommendations for PPH prevention where outcomes were rated by an independent panel. Since the two primary endpoints serve independent objectives, the Type I error rate for multiplicity of endpoints was not adjusted. </p>\n<p>\n <u><strong>The trial has two primary objectives:</strong></u></p>\n<p>\n (1) To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.</p>\n<p>\n (2) To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour.</p>\n<p>\n <u><strong>For both objectives the hypotheses are:</strong></u></p>\n<p>\n i) Carbetocin RTS 100 μg/ml IM is non-inferior to oxytocin 10IU IM in terms of the proportion of women with blood loss ≥500 mL or use of additional uterotonic drugs after vaginal delivery within a non-inferiority margin of 1.16 on the relative risk scale (objective (1)), and the proportion of women with blood loss ≥1000 mL after vaginal delivery within a non-inferiority margin of 1.23 on the relative risk scale (objective (2)).</p>\n<p>\n <em>Justification</em>: In the conventional superiority trial, the aim is to determine whether one intervention is superior to another, for example, whether an uterotonic is superior to nothing. By contrast, in a non-inferiority trial, the aim is to determine whether an alternative intervention with certain advantages is similar to a gold standard. Oxytocin 10 IU (IM or IV) represents the gold standard management strategy for reducing blood loss in the third stage of labour. The advantages of carbetocin RTS are being more heat-stable than oxytocin and having a longer half-life. In order to evaluate the effectiveness of carbetocin RTS, which has these advantages, it has to be compared to oxytocin to assess whether it is non-inferior to it in efficacy.</p>\n<p>\n ii) Carbetocin RTS 100 μg IM is superior to oxytocin 10 IU IM in terms of the proportion of women with blood loss ≥500 mL or use of additional uterotonic drugs (objective (1)), and in terms of the proportion of women with blood loss ≥1000 mL after vaginal delivery (objective (2)). For each of the two primary endpoints, superiority will be tested if non-inferiority has been demonstrated.</p>\n<div>\n  </div>\n<div>\n <u>Rationale</u>: Superiority of the new treatment for the primary outcome would be an additional</div>\n<div>\n benefit. If carbetocin is demonstrated to be superior to oxytocin in efficacy, it would be the</div>\n<div>\n preferred option.</div>\n
      • study_title<p>\n A phase III, randomized, double-blind, active, controlled, multinational, multicentre,  non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally.</p>\n
      • laymans_summary<p>\n PPH is the leading cause of maternal mortality in low-income countries and it contributes to nearly a quarter of maternal deaths globally. PPH is a significant contributor to severe maternal morbidity and long term disability, as well as to a number of other severe maternal conditions, generally associated with more substantial blood loss, including shock and organ dysfunction2-4. Improving health care for women during childbirth in order to prevent and treat PPH is an essential step towards the achievement of the United Nations Millennium Development Goals.</p>\n<p>\n Despite oxytocin being a well-known and extensively studied, there is limited information on its stability at tropical temperatures, mainly at extreme climate conditions and storage under refrigeration is recommended, however carbetocin RTS is a promising intervention for reducing PPH particularly in settings where cold storage is difficult to achieve and maintain.</p>\n<p>\n Merck for Mothers is a 10-year initiative focused on creating a world where no woman has to die from complications of pregnancy and childbirth. Two of its priority areas are postpartum haemorrhage (PPH) and hypertensive disorders of pregnancy.</p>\n<p>\n carbetocin RTS is a promising intervention for reducing PPH particularly in settings where cold storage is difficult to achieve and maintain. An international technical consultation was convened and it was agreed to proceed with a randomized controlled trial to evaluate the effectiveness of carbetocin RTS compared to oxytocin when used intramuscularly. This was based on four considerations:</p>\n<p>\n (i) frequent concerns and documentation of the quality of oxytocin and its stability in some developing countries;</p>\n<p>\n (ii) the potential advantage of carbetocin RTS due to its longer half-life (than oxytocin) especially when administered intramuscularly in addition to its heat stability;</p>\n<p>\n (iii) research will be funded by Merck for Mothers and conducted by WHO independently in terms of the management, analysis and publication of the research results</p>\n<p>\n (iv) if non-inferior to oxytocin, carbetocin RTS formulation will be made available in high-burden countries at an accessible public sector price comparable to the current oxytocin price based on a signed memorandum of understanding between WHO, Ferring and Merck.</p>\n<p>\n  </p>\n
      • short_titleA phase III, non-inferiority trial using Carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering
      • protocol_noECCT/15/03/01
      • version_noVersion 1.1
      • date_of_protocol08-12-2014
      • study_drugCarbetocin RTS 100 μg and oxytocin 10 IU.
      • disease_conditionPostpartum haemorrhage
      • 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_nameWomen will receive a single intramuscular dose of either oxytocin or carbetocin immediately after the birth of the baby
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameOxytocin
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressbianca.hibbert@quintiles.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
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      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantBianca Hibbert
      • declaration_date105-03-2015
      • declaration_principal_investigatorProfessor Zahida Qureshi
      • declaration_date205-03-2015
      • placebo_presentNo
      • study_objectives<ul>\n <li>\n <strong>To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.</strong></li>\n <li>\n <strong>To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour</strong></li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n <strong>To be eligible for inclusion into this trial, the women must fulfill all the following criteria:</strong></div>\n<div>\n  </div>\n<div>\n 1. Be expected to deliver vaginally</div>\n<div>\n 2. Have a cervical dilatation equal to or less than 6cm</div>\n<div>\n 3. Have a known singleton pregnancy</div>\n<div>\n 4. Provide written informed consent before any trial-related procedures are carried out.</div>\n
      • principal_exclusion_criteria<div>\n <strong>Women are not eligible for this trial if they fulfill any of the following exclusion criteria:</strong></div>\n<div>\n  </div>\n<div>\n 1. Are in an advanced first stage of labour (>6 cm cervical dilatation) or too distressed to understand, confirm and give informed consent regardless of cervical dilatation</div>\n<div>\n 2. Are non-emancipated minors (as per local regulations) without a guardian</div>\n<div>\n 3. Have been scheduled for a planned caesarean section</div>\n<div>\n 4. The birth is considered an abortion according to local guidelines</div>\n<div>\n 5. Have known allergies to carbetocin, other oxytocin homologues or excipients in the medicinal products used in the trial</div>\n<div>\n 6. Have serious cardiovascular disorders</div>\n<div>\n 7. Are not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum haemorrhage) or mental disorder</div>\n
      • primary_end_points<p>\n (1) To evaluate non-inferiority of carbetocin RTS 100 μg IM versus oxytocin 10 IU IM after vaginal delivery in the prevention of the composite endpoint “blood loss of 500 mL or more or the use of additional uterotonics” at one hour and up to two hours for women who continue to bleed after one hour.</p>\n<p>\n (2) To evaluate non-inferiority of carbetocin RTS 100 µg IM versus oxytocin 10 IU IM in the prevention of sPPH (≥1000 mL blood loss) at one hour and up to two hours for women who continue to bleed after one hour. </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The Kenyatta National Hospital labour ward has 40 full time nurse/midwives. The Hospital it a Tertiary referral site where approximately 13,000 deliveries are conducted and the Caesarean sections rate is around 35%. There is 24 hour theatre coverage , one theatre is for emergencies is functional 24 hours and the second one for elective surgeries is operational Monday to Friday 8am to 5pm. Both theatres are in labour ward. The hospital has a High dependency unit and an ICU.</p>\n<p>\n There is full time consultant coverage with the postgraduates being first on call.</p>\n<p>\n The study will employ one Project coordinator who will be a midwife and will oversee the running of the project and supervise the six midwives (research midwives )we will employ to work in labour ward on shift duty to carry out the recruitment for patients and  delivery as per study protocol and data collection.</p>\n<p>\n In addition a Data entry clerk will be employed for data entry. Prof. Zahida P Qureshi will be overall incharge and Dr Osoti will assist.</p>\n
      • other_details_explanation<p>\n This study is being conducted in developing countries where the PPH incidence and the need for a heat stable treatment for PPH are high. The only exceptions are UK and Singapore which were included for registration purposes.</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:210px;\">\n <p>\n <strong>Countries </strong></p>\n </td>\n <td style=\"width:409px;\">\n <p>\n <strong> Competent Authority  Name and Address </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n South Africa</td>\n <td style=\"width:210px;\">\n <p>\n The Registrar    </p>\n Medicines Control Council<br />\n Hallmark Building<br />\n PRETORIA<br />\n 0001</td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n UK</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Information Processing Unit<br />\n Area 6<br />\n MHRA<br />\n 151 Buckingham Palace Road<br />\n Victoria<br />\n SW1W 9SZ</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Uganda</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Uganda National Council For Science And Technology (UNCST) Research</p>\n <p>\n Uganda National Council for Science & Technology, Plot 6 Kimera Road Ntida, Kampala</p>\n <p>\n Uganda</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Nigeria</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n National Agency for Food and Drug Administration and Control (NAFDAC)</p>\n <p>\n Plot 2032, Olusegun Obasanjo Way, Wuse Zone 7-Abuja FCT Nigeria.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Egypt</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Ministry of Health - Central Directorate for Research & Health Development (The new administrative building – floor 7)</p>\n <p>\n 3 Magles El Shaab St.</p>\n <p>\n Cairo.</p>\n <p>\n P.O.: 11516</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n India</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Drugs Controller General (India),</p>\n <p>\n Directorate General of Health Services</p>\n <p>\n FDA Bhavan</p>\n <p>\n Kotla Road</p>\n <p>\n New Delhi</p>\n <p>\n 110002</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Singapore</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Health Sciences Authority</p>\n <p>\n 11 Outram Road<br />\n Singapore</p>\n <p>\n 169078</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Thailand</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n Food and Drug Administration Ministry of Public Health</p>\n <p>\n Thiwanon Road</p>\n <p>\n Nonthaburi</p>\n <p>\n 11000</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;\">\n <p>\n Argentina</p>\n </td>\n <td style=\"width:409px;\">\n <p>\n MOH –ANMAT</p>\n <p>\n Avenida de Mayo 869 (C1084AAD)</p>\n <p>\n Ciudad Autónoma de Buenos Aires</p>\n <p>\n Argentina</p>\n <p>\n  </p>\n <p>\n And</p>\n <p>\n  </p>\n <p>\n Regional MOH.- Santa Fe province</p>\n <p>\n Bv. Pellegrini 3100, 1er. P – Santa Fe  (3000) Santa Fe Argentina</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:210px;height:61px;\">\n <p>\n Brazil</p>\n </td>\n <td style=\"width:409px;height:61px;\">\n <h5>\n ANVISA – Agência Nacional de Vigilância Sanitária</h5>\n <p>\n COPEC - Coordenação de Pesquisa Clínica em Medicamentos e Produtos Biológicos</p>\n <p>\n Setor de Indústria e Abastecimento (SIA)</p>\n <p>\n Trecho 5, Área Especial 57, 71205-050 – Brasília – DF – Brazil</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n Applications for only South Africa, UK, Nigeria and Egypt have been submitted. And no approvals. There were submissions prior to the Quintiles involvement, e.g. in India, and some other countries, but with the previous protocol, without ICFs etc. Some EC approvals were received, but need to be amended with the current submission to be valid.</p>\n
      • other_details_regulatory_rejected<p>\n No approvals or rejections received as yet.</p>\n
      • other_details_regulatory_halted<h3 style=\"color:blue;\">\n <span dir=\"rtl\"><span style=\"color:#000000;\"><tt><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Not applicable</span></span></tt></span></span></h3>\n
      • estimated_durationThe total study duration will be approximately 24 months.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifymultinational, multicentre, noninferiority trial
      • design_controlled_comparatorCarbetocin RTS
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyoxytocin
      • single_site_member_stateYes
      • location_of_areaKenyatta National Hospital
      • single_site_physical_addressKenyatta National Hospital, Nairobi, Kenya
      • single_site_contact_personProf. Zahida P Qureshi
      • single_site_telephoneDepartment 2726300 Ext. 43372 or 2726360
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states11
      • number_of_sites
      • multi_country_listArgentina, Brazil, Egypt, India, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the United Kingdom.
      • data_monitoring_committeeYes
      • total_enrolment_per_site4000 participants
      • total_participants_worldwideApproximately 30\'000 women delivering vaginally will be recruited in this trial.
      • population_less_than_18_yearsYes
      • 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_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameZahida
      • investigator1_middle_name
      • investigator1_family_name Qureshi
      • investigator1_qualificationMasters of Medicine in Obstetrics and Gynecology, Bachelor of Medicine and Bachelor of Surgery
      • investigator1_professional_addressKenyatta National Hospital
      • investigator1_telephoneDepartment 2726300 Ext. 43372 or 2726360 or 0733 605140
      • investigator1_emailzahida@qureshi.co.ke
      • organisations_transferred_Yes
      • number_participantsIn Kenya, approximately 4000 participants will be taking part in the study.
      • notification<p>\n WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.</p>\n
      • approval_date27-07-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The result of this trial indicate that carbetocin and oxytocin have similar efficacy profiles in the prevention of PPH.  The co-primary objective for blood loss of 500mL or more or use of additional uterotonics was met with carbetocin demontrating non-inferiority compared with oxytocin. However, the co primary objective for blood loss of 1000mL with carbetocion demonstrating non-inferiority compared with oxytocin was not met. Although the upper limit of 95% CI for co-primary outcome blood loss of 1000mL or more was just above the margin of non-inferiority, most likely values for RR were below the margin, suggesting that the trial was slightly underpowered to show non-inferiority for this outcome.  The overall AE data are consistant with the established safety profiles and show minimal differences between carbetocin and oxytocin.  BAsed on the overall efficacy and safety profiles, carbetocin and oxytocin appear to offer cimilar treatment outcomes</p>\n<p>\n The date of global end of trial was 07 March 2018. The Global end of trial is defined as the date the final clinical database lock.</p>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-06-26 12:23:55
      • created2015-02-16 10:14:01
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id264
        • application_id389
        • given_nameZahida
        • middle_name
        • family_name Qureshi
        • qualificationMasters of Medicine in Obstetrics and Gynecology, Bachelor of Medicine and Bachelor of Surgery
        • professional_addressKenyatta National Hospital
        • telephoneDepartment 2726300 Ext. 43372 or 2726360 or 0733 605140
        • emailzahida@qureshi.co.ke
        • created2015-02-16 10:29:22
        • modified2020-06-26 12:23:55
    • SiteDetail(array)
      • 0(array)
        • id316
        • application_id389
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-02-16 10:29:22
        • modified2020-06-26 12:23:55
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id203
        • application_id389
        • sponsorWorld Health Organization
        • sponsor_typeOthers
        • contact_personDr A. Metin Gülmezoglu
        • addressDepartment of Reproductive Health & Research, Avenue Appia 20, 1211 Geneva 27, Switzerland
        • telephone_number+41-22-7913417
        • fax_number+41-22-7914171
        • cell_number+41-22-7913417
        • email_addressgulmezoglum@who.int
        • created2015-02-16 10:29:22
        • modified2020-06-26 12:23:55
  • 1(array)
    • Application(array)
      • id387
      • user_id32
      • trial_status_id5
      • abstract_of_study<div>\n  </div>\n<div>\n Short Title: IVERMAL study</div>\n<div>\n  </div>\n<div>\n Background and rationale: In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to 40% in 2008, where it has now stagnated. Innovative approaches are needed to continue towards elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at this dose has a potent, but short-lived effect for 6-11 days on mosquito survival, egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal effects. Regulatory studies have shown ivermectin is very well tolerated and safe even up to 2,000 mcg/kg. We will conduct dose finding studies to evaluate the transmission blocking effect of high-dose ivermectin to define the optimal dose for future use of ivermectin in combination with artemisinin-based combination therapy (ACT) for mass drug administration (MDA) for malaria in Kenya. This study explores a research question of global relevance. A prolonged transmission blocking effect of ivermectin could have substantial consequences for malaria control in the next decades. We expect the results to inform the national regulator in Kenya, national malaria control programs in malaria endemic countries, to inform WHO guidelines, and to contribute to the regulatory process.</div>\n<div>\n  </div>\n<div>\n Primary objective: To determine the safety and efficacy of ivermectin 0, 300, 600 mcg/kg/day for 3 days, when provided with a standard 3-day course of dihydroartemisinin-piperaquine (DP) for uncomplicated malaria, on 14-day mosquito survival after feeding experiment performed at 7 days after treatment.</div>\n<div>\n Hypothesis: High dose ivermectin at 600 mcg/kg daily for 3 days is well tolerated and safe and will have a longer lasting mosquitocidal effect and a greater potential impact on malaria transmission.</div>\n<div>\n  </div>\n<div>\n Overview Study Design: Double-blind placebo-controlled, parallel-group, 3-arm, superiority trial to determine the effect of different doses of ivermectin on mosquito survival. The unit of randomization will be the patient, and the unit of analysis will be the mosquito. The primary endpoint will be mosquito survival 14 days after a feed on blood from a patient who has started ivermectin 7 days earlier (i.e. about 5 days after the last dose of ivermectin with a 3-day regimen administering ivermectin at 0, 24, and 48 hours [days 0, 1 and 2]). Because mosquito feeding involves approximately 100 mosquitoes per feed, the study will use a cluster randomized design with the patient as the cluster unit. The study will have a nested rich pharmacokinetic component in the first 12 patients per study arm, and a sparse sampling population pharmacokinetic component in the remaining patients. The study will also compare the potential modifying effect of the method of feeding by comparing the mosquitocidal effect of ivermectin with membrane versus direct skin feeding.</div>\n<div>\n Sites: The study will be conducted in the Provincial Hospital in Kisumu, western Kenya recently renamed to the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Dependent on the recruitment rate, enrolment will be expanded to up to 3 other hospitals in Kisumu and Siaya counties.</div>\n<div>\n Study Population: Adults with uncomplicated falciparum malaria attending out-patient clinics.</div>\n<div>\n  </div>\n<div>\n Study Interventions: 1. Dihydroartemisinin-piperaquine (DP) alone, DP plus ivermectin 0 mcg/kg/day for 3 days (“placebo” arm); 2. DP plus ivermectin 300 mcg/kg/day plus 300 mcg/kg/day ivermectin-placebo for 3 days (“300 mcg/kg” arm); 3. DP plus ivermectin 600 mcg/kg/day (“600 mcg/kg” arm).</div>\n<div>\n Outcome Measures: Primary efficacy outcome: Mosquito survival: Survival of mosquitoes at 14 days after feeding on blood taking from study participants who started the 3-day ivermectin and DP regimen 7 days earlier. Primary safety outcome measure: Mydriasis quantitated by pupillometry. Key secondary safety outcome: QTc(F) prolongation by ECG.</div>\n<div>\n  </div>\n<div>\n Follow-up procedures: Treatment visits on day 1 and 2. Post-treatment follow-up at day 2 (+4 hours after last dose of ivermectin), days 7, 10, 14, 21, and 28.</div>\n<div>\n Sample size: Main trial: 141 participants (47 per arm); Rich pharmacokinetic study: 36 participants (12 per arm); direct feeding vs membrane feeding 27 participants (9 per arm, day 7 post ivermectin only).</div>\n<div>\n  </div>\n<div>\n Data Analysis: Primary outcomes will be summarised by number (%) of events and analysed using a Generalized Estimating Equations (GEE) model with binomial distribution and log link function that includes treatment as a single predictor taking the cluster design into account, which will generate risk ratios together with their 95% confidence intervals of having a primary endpoint between two active dose groups and the placebo group. Exchangeable covariance structure will be used. The primary endpoint analysis will be based on the ITT population.</div>\n<div>\n  </div>\n<div>\n Partner institutions: KEMRI and CDC Collaboration, Kisumu, western Kenya; Kenya Ministry of Health, Liverpool School of Tropical Medicine; US Centers for Disease Control and Prevention</div>\n<div>\n  </div>\n<div>\n Funding: Malaria Eradication Scientific Alliance (MESA) which is funded through a grant from the Bill and Melinda Gates Foundation.</div>\n
      • study_title<p>\n <font face=\"Arial, sans-serif\"><span style=\"line-height: 18.3999996185303px;\"><b>Efficacy and safety of high-dose Ivermectin for reducing malaria transmission: A dose finding study</b></span></font></p>\n
      • laymans_summary<p>\n --</p>\n
      • short_titleIVERMAL study
      • protocol_noECCT/15/02/03
      • version_no1.4
      • date_of_protocol27-01-2015
      • study_drugIvermectin
      • 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_nameIvermectin
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresstsang@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data0
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist0
      • statistical_analysis_plan1
      • applicant_contractual_agreement0
      • declaration_applicantTony Sang
      • declaration_date116-02-2015
      • declaration_principal_investigatorMenno Smit
      • declaration_date216-02-2015
      • placebo_presentYes
      • study_objectives<div>\n The overall aim of the study is to compare the effect of 3-day courses with ivermectin 0, 300, 600 mcg/kg/day when given in combination with standard 3-day course of dihydroartemisinin-piperaquine, on mosquito survival.</div>\n<div>\n  </div>\n<div>\n PRIMARY OBJECTIVE</div>\n<div>\n  </div>\n<div>\n To determine the safety and efficacy of ivermectin 0, 300, 600 mcg/kg/day for 3 days, when provided with a standard 3-day course of dihydroartemisinin-piperaquine (DP) for uncomplicated malaria, on 14-day mosquito survival after feeding experiment performed at 7 days after treatment (i.e. 5 days after the last dose of ivermectin).</div>\n<div>\n  </div>\n<div>\n SECONDARY OBJECTIVES</div>\n<div>\n  </div>\n<div>\n 1. To determine the effect of different doses of ivermectin on oocyst and sporozoite rates.</div>\n<div>\n 2. To determine the effect of different doses of ivermectin on other ectoparasites (e.g. head lice, scabies).</div>\n<div>\n 3. To determine the pharmacokinetic profile of the different ivermectin regimens</div>\n<div>\n 4. To determine if ivermectin interacts with the pharmacokinetics of piperaquine</div>\n<div>\n 5. To determine whether the addition of ivermectin to DP interacts with the ability of DP to clear asexual and sexual stage parasites</div>\n<div>\n 6. To determine the role of genetic variants of CYP3A4 activity in metabolizing ivermectin</div>\n<div>\n 7. To determine the effect of direct feeding versus membrane feeding on mosquito surviv</div>\n
      • principal_inclusion_criteria<div>\n •<span class=\"Apple-tab-span\" style=\"white-space: pre;\"> </span>Asymptomatic, uncomplicated Plasmodium falciparum infection</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Positive malaria microscopy or malaria RDT (pLDH)</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Age: 18-50 years</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Provide written informed consent</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Agree to be able to travel to clinic on days: 1, 2, 7, 10, 14, 21, and 28</div>\n<div>\n  </div>\n<div>\n  </div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n  </div>\n<p>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Signs or symptoms of severe malaria</p>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Unable to provide written informed consent</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>For women: pregnancy or lactation</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Hypersensitivity to ivermectin or DP</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Qtc > 460 ms on ECG</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Body Mass Index (BMI) below 16 or above 32 kg/m2</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Haemoglobin concentration below 9 g/dL</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Taken ivermectin in the last month</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Taken dihydroartemisinin-piperaquine in the last 12 weeks</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Loa loa as assessed by travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>History and/or symptoms indicating chronic illness</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Current use of tuberculosis or anti-retroviral medication</div>\n<div>\n •<span class=\"Apple-tab-span\" style=\"white-space:pre\"> </span>Previously enrolled in the same study</div>\n<div>\n  </div>\n
      • primary_end_points<ul>\n <li>\n Mosquito survival: Survival of mosquitoes at 14 days after feeding on blood taking from study participants who started the 3-day ivermectin and DP regimen 7 days earlier</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n Study Coordinator, Menno Smit</div>\n<div>\n Project manager, Elizabeth Nyothach</div>\n<div>\n Pharmacist, Tony Sang</div>\n<div>\n Regulatory Officer, Juliana Kisakye</div>\n<div>\n Clinical Officer 1, name TBC</div>\n<div>\n Clinical Officer 2, name TBC</div>\n<div>\n Clinical Officer 3, name TBC</div>\n<div>\n Microscopist 1, name TBC</div>\n<div>\n Microscopist 2, name TBC</div>\n<div>\n Phlebotomist 1, name TBC</div>\n<div>\n Laboratory technician 1, TBC</div>\n<div>\n Entomology laboratory assistant 1, TBC</div>\n<div>\n Entomology laboratory assistant 2, TBC</div>\n<div>\n Data manager, TBC</div>\n<div>\n Data clerk, TBC</div>\n<div>\n  </div>\n<div>\n The study will be conducted in the Provincial Hospital in Kisumu, western Kenya recently renamed to the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). JOOTRH is a major tertiary care hospital with self-contained paediatric, medical, and obstetric wards, as well as an intensive care unit with mechanical ventilators and telemetry capabilities. Almost 25,000 outpatients are treated for clinical malaria at JOOTRH annually, of which one-third are laboratory confirmed. Approximately 20% of these patients are 18-50 years old. On a daily basis around 4.6 adults (18–50 years old) test positive for malaria in JOOTRH’s outpatient clinic.</div>\n<div>\n  </div>\n
      • other_details_explanation<p>\n The study involves patients with malaria.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<div style=\"margin-left: 40px;\">\n KEMRI  SSC- 12 Feb 2015</div>\n<div style=\"margin-left: 40px;\">\n  </div>\n<div style=\"margin-left: 40px;\">\n Liverpool School of Tropical Medicine  -   23-Jan-2015</div>\n<div>\n  </div>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration4-6 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sitesOne main site and three potential expansion sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteJaramogi Oginga Odinga Teaching & Referral Hospital : 0-141\nKisumu District Hospital : 0-141\nSiaya District Hospital : 0-141\nV District Hospital: 0-141
      • total_participants_worldwide141
      • 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_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_nameMenno
      • investigator1_middle_nameRoderick
      • investigator1_family_nameSmit
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressKEMRI/CDC, P.O. Box 1578, Kisumu 40100, Kenya
      • investigator1_telephone+254 703 991513
      • investigator1_emailmenno.smit@liverpool.ac.uk
      • organisations_transferred_Yes
      • number_participants141
      • notification
      • approval_date26-03-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-01-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has now been approved
      • final_report<div>\n <strong>Summary</strong></div>\n<div>\n Background Ivermectin is being considered for mass drug administration for malaria due to its ability to kill mosquitoes feeding on recently treated individuals. However, standard, single doses of 150–200 μg/kg used for onchocerciasis and lymphatic filariasis have a short-lived mosquitocidal effect (<7 days). Because ivermectin is well tolerated up to 2000 μg/kg, we aimed to establish the safety, tolerability, and mosquitocidal efficacy of 3 day courses of high-dose ivermectin, co-administered with a standard malaria treatment.</div>\n<div>\n  </div>\n<div>\n <strong>Methods</strong> We did a randomised, double-blind, placebo-controlled, superiority trial at the Jaramogi Oginga Odinga Teaching and Referral Hospital (Kisumu, Kenya). Adults (aged 18–50 years) were eligible if they had confirmed symptomatic uncomplicated Plasmodium falciparum malaria and agreed to the follow-up schedule. Participants were randomly assigned (1:1:1) using sealed envelopes, stratified by sex and body-mass index (men: <21 vs ≥21 kg/m²; women: <23 vs ≥23 kg/m²), with permuted blocks of three, to receive 3 days of ivermectin 300 μg/kg per day, ivermectin 600 μg/kg per day, or placebo, all co-administered with 3 days of dihydroartemisinin-piperaquine. Blood of patients taken on post-treatment days 0, 2 + 4 h, 7, 10, 14, 21, and 28 was fed to laboratory-reared Anopheles gambiae sensu stricto mosquitoes, and mosquito survival was assessed daily for 28 days after feeding. The primary outcome was 14-day cumulative mortality of mosquitoes fed 7 days after ivermectin treatment (from participants who received at least one dose of study medication). The study is registered with ClinicalTrials.gov, number NCT02511353.</div>\n<div>\n  </div>\n<div>\n <strong>Findings</strong> Between July 20, 2015, and May 7, 2016, 741 adults with malaria were assessed for eligibility, of whom 141 were randomly assigned to receive ivermectin 600 μg/kg per day (n=47), ivermectin 300 μg/kg per day (n=48), or placebo (n=46). 128 patients (91%) attended the primary outcome visit 7 days post treatment. Compared with placebo, ivermectin was associated with higher 14 day post-feeding mosquito mortality when fed on blood taken 7 days post treatment (ivermectin 600 μg/kg per day risk ratio [RR] 2·26, 95% CI 1·93–2·65, p<0·0001; hazard ratio [HR] 6·32,</div>\n<div>\n 4·61–8·67, p<0·0001; ivermectin 300 μg/kg per day RR 2·18, 1·86–2·57, p<0·0001; HR 4·21, 3·06–5·79, p<0·0001). Mosquito mortality remained significantly increased 28 days post treatment (ivermectin 600 μg/kg per day RR 1·23, 1·01–1·50, p=0·0374; and ivermectin 300 μg/kg per day 1·21, 1·01–1·44, p=0·0337). Five (11%) of 45 patients receiving ivermectin 600 μg/kg per day, two (4%) of 48 patients receiving ivermectin 300 μg/kg per day, and none of 46 patients receiving placebo had one or more treatment-related adverse events.</div>\n<div>\n  </div>\n<div>\n <strong>Interpretation </strong>Ivermectin at both doses assessed was well tolerated and reduced mosquito survival for at least 28 days</div>\n<div>\n after treatment. Ivermectin 300 μg/kg per day for 3 days provided a good balance between efficacy and tolerability, and</div>\n<div>\n this drug shows promise as a potential new tool for malaria elimination.</div>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2021-01-26 12:43:18
      • created2015-02-13 17:23:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id261
        • application_id387
        • given_nameMenno
        • middle_nameRoderick
        • family_nameSmit
        • qualificationMD, MPH
        • professional_addressKEMRI/CDC, P.O. Box 1578, Kisumu 40100, Kenya
        • telephone+254 703 991513
        • emailmenno.smit@liverpool.ac.uk
        • created2015-02-13 17:33:17
        • modified2021-01-26 12:43:18
    • SiteDetail(array)
      • 0(array)
        • id314
        • application_id387
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)
        • physical_addressKakamega Road, Kisumu, Kenya
        • contact_detailsKEMRI/CDC-CRC, P.O. Box 1578, Kisumu 40100, Kenya
        • contact_personMenno Smit
        • site_capacity(null)
        • misc(null)
        • created2015-02-13 17:33:17
        • modified2021-01-26 12:43:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id318
        • application_id387
        • county_id42
        • site_nameKisumu District Hospital (KDH),
        • physical_addressKisumu
        • contact_detailsP. O. Box 4685, Kisumu
        • contact_personMenno Smit
        • site_capacity(null)
        • misc(null)
        • created2015-02-17 17:10:55
        • modified2021-01-26 12:43:18
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id319
        • application_id387
        • county_id41
        • site_nameSiaya District Hospital
        • physical_addressSiaya
        • contact_detailsP. O. Box 144, Siaya
        • contact_personMenno Smit
        • site_capacity(null)
        • misc(null)
        • created2015-02-17 17:10:55
        • modified2021-01-26 12:43:18
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 3(array)
        • id320
        • application_id387
        • county_id38
        • site_nameVihiga District Hospital
        • physical_addressVihiga
        • contact_detailsP.O. Box 1069, Vihiga
        • contact_personMenno Smit
        • site_capacity(null)
        • misc(null)
        • created2015-02-17 17:10:55
        • modified2021-01-26 12:43:18
        • County(array)
          • id38
          • county_nameVihiga
          • created2012-06-15 10:26:37
          • modified2012-06-15 10:26:37
    • Sponsor(array)
      • 0(array)
        • id201
        • application_id387
        • sponsorLiverpool School of Tropical Medicine
        • sponsor_typeResearch Institution
        • contact_personMenno Smit
        • addressKEMRI/CDC, P.O. Box 1578, Kisumu 40100, Kenya
        • telephone_number+254 703 991513
        • fax_number
        • cell_number+254 703 991513
        • email_addressmenno.smit@liverpool.ac.uk
        • created2015-02-13 17:33:17
        • modified2021-01-26 12:43:18
  • 2(array)
    • Application(array)
      • id379
      • user_id72
      • trial_status_id5
      • abstract_of_study<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:599px;\" width=\"599\">\n <tbody>\n <tr>\n <td style=\"width:20%;height:106px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Design:</strong></span></p>\n </td>\n <td style=\"width:80%;height:106px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">This study, which shall be conducted in two phases, will examine procedural and clinical outcomes, as well as participant and provider acceptability, of adaptations of the Shang Ring technique for male circumcision that would simplify its use.</span></p>\n <p style=\"margin-left:.25in;\">\n <span style=\"font-family:verdana,geneva,sans-serif;\">·         Phase I will explore use of the no-flip technique with historical data from standard Shang Ring circumcisions in Africa used as the comparison group. Men will be randomized to Shang Ring removal at 7 days vs. being followed to observe for spontaneous detachment,</span></p>\n <p style=\"margin-left:.25in;\">\n <span style=\"font-family:verdana,geneva,sans-serif;\">·         Phase II will be a randomized trial comparing use of topical vs. injectable anesthesia.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Population:</strong></span></p>\n </td>\n <td style=\"width:450px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">The study population will include Kenyan men and boys ages 10 years and older seeking circumcision at a study sits. A total of 230 participants will be recruited into Phase I and 345 into Phase II. Because of the possibility that boys and men could have different outcomes, we will recruit participants equally in two age groups in both phases; 10-15 and >15 years old.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:126px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Duration:</strong></span></p>\n </td>\n <td style=\"width:450px;height:126px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Approximately 8 months for completion through follow-up of the two phases of the study (exact timing will depend on recruitment rate). In the first phase, participants shall be followed-up at 7, 14, 21, 28, 35, and 42 days post circumcision, although study participation will end once complete wound healing has been documented. In the second phase, participants shall be followed up at 7 and 42 days post-circumcision. In both phases men will be followed beyond 42 days if necessary to document complete wound healing.</span></p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Primary Objectives & </strong></span></p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Endpoints:</strong></span></p>\n </td>\n <td style=\"width:450px;height:63px;\">\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Phase I: Assess safety of the no-flip technique for Shang Ring circumcision by determining the rate of moderate and severe adverse events (AE) following use of the no-flip technique. </span></p>\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Phase II: Assess pain experienced during the Shang Ring circumcision procedure with topical vs. injectable anesthesia. The outcome metric would be maximum pain experienced during the Shang Ring circumcision, assessed using the visual analogue scale (VAS) score, reported immediately after completion of the procedure.</span></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:149px;height:20px;\">\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\"><strong>Sites:</strong></span></p>\n </td>\n <td style=\"width:450px;height:20px;\">\n <p>\n  </p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Homa Bay County Hospital, Homa Bay County, Kenya</span></p>\n <p>\n <span style=\"font-family:verdana,geneva,sans-serif;\">Vipingo Health Center, Kilifi County, Kenya</span></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • study_title<h2>\n <span style=\"font-size:12px;\"><span style=\"font-family:verdana,geneva,sans-serif;\">Simplifying the Shang Ring Technique for Circumcision of Men and Boys</span></span></h2>\n
      • laymans_summary(null)
      • short_titleSimplifying ShangRing Circumcision for Men and Boys
      • protocol_noECCT/15/01/03
      • version_no4
      • date_of_protocol09-01-2015
      • study_drugN/A
      • disease_conditionN/A
      • 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_nameShang Ring Device
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressqawori@engenderhealth.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_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantQuentin Awori
      • declaration_date127-01-2015
      • declaration_principal_investigatorMark Barone - Principal investigator
      • declaration_date227-01-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Aged 10 years and older;</li>\n <li>\n Uncircumcised upon clinical examination;</li>\n <li>\n In good general health;</li>\n <li>\n Free of genital ulcerations or other visible signs of STI upon clinical examination;</li>\n <li>\n Participant and parent or legally acceptable representative (LAR) as applicable must be able to understand study procedures and requirements of study participation;</li>\n <li>\n Freely consents to participate in the study and signs a written informed consent form if 18 years of age or greater</li>\n <li>\n Accompanied by the parent/LAR, who freely consents and signs an informed consent form for participation of the child into the study for participants less than 18 years old;</li>\n <li>\n Assent from participant less than 18 years old who understand study procedure;</li>\n <li>\n Participant must agree to return to the study site for the full schedule of follow-up visits after his circumcision (or as appropriate the Parent or LAR must agree to bring the participant);</li>\n <li>\n Participant and parent/LAR as appropriate must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Has a known allergy or sensitivity to lidocaine or other local anesthesia;</li>\n <li>\n Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;</li>\n <li>\n Has known bleeding/clotting disorder (e.g. hemophilia);</li>\n <li>\n Has any congenital genitourinary abnormality;</li>\n <li>\n Has an active genital infection, anatomic abnormality or other condition (e.g. diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or,</li>\n <li>\n Is currently participating in another biomedical research study. </li>\n</ol>\n
      • primary_end_points<p>\n <u><strong>Phase I of study</strong></u></p>\n<p>\n Assess safety of the no-flip technique for Shang Ring circumcision by determining the rate of moderate and severe adverse events (AE) following use of the no-flip technique.  </p>\n<p>\n <strong><u>Phase II of study</u></strong></p>\n<p>\n Assess pain experienced during the Shang Ring circumcision procedure with topical vs. injectable anesthesia. The outcome metric would be maximum pain experienced during the Shang Ring circumcision, assessed using the visual analogue scale (VAS) score, reported immediately after completion of the procedure.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyAcceptability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyMedical device in individuals above 10 years of age
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <u><strong>Homa Bay</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Staff at site who will conduct the research</strong></p>\n<ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <li>\n Hospital surgeon (Homa bayu)\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Dr Raymond Simba (Co investigator)- MMED Surg</li>\n </ul>\n </li>\n <li>\n 2 nurses - KRCHN\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Jairus Oketch</li>\n <li>\n (Still to be recruited)</li>\n </ul>\n </li>\n <li>\n 1 Research Assistant\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Dan Ouma </li>\n </ul>\n </li>\n <li>\n 1 Lead social mobiliser\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Nereah Obura</li>\n </ul>\n </li>\n <li>\n Support staff (1)</li>\n</ul>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Site & Facility building</strong></p>\n<p style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n Homa bay distirct hospital - VMMC Theatre</p>\n<p style=\"margin-top: 0px; margin-right: 0px; margin-bottom: 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n ================================================</p>\n<p style=\"margin-top: 0px; margin-right: 0px; margin-bottom: 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <u><strong>Vipingo</strong></u></p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Staff at site who will conduct the research</strong></p>\n<ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <li>\n Hospital Clinical Officer in charge\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Judy Kinya (Local PI)</li>\n </ul>\n </li>\n <li>\n 2 nurses - KRCHN\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n (to be recruited)</li>\n </ul>\n </li>\n <li>\n 1 Research Assistant\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n Millie Oundo </li>\n </ul>\n </li>\n <li>\n 1 Lead social mobiliser\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li>\n David Mwamkita</li>\n </ul>\n </li>\n <li>\n Support staff (1)</li>\n</ul>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n <strong>Site & Facility building</strong></p>\n<p style=\"margin: 0px 0px 10px 40px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px;\">\n Vipingo Health Center - theatre</p>\n
      • other_details_explanation<p>\n Kenya was the first country where research on the Shang ring as a device for VMMC was conducted (2009). Since then alot of advancement into the use of the device has be gained plus inroads with the ministry of health (VMMC) and various stake holders.</p>\n<p>\n As this study is aimed at further improving the use of the device, Kenya is most suited to provide this environment of advanced research of this kind.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Weil Cornell Medical College - 3 Oct 2014</p>\n<p>\n Kenya Medical Research Institute (KEMRI) - 9th Jan 2015</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRemoval of day 7 group (P
      • 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_siteNo preset maximum or minimum numbers per site.
      • total_participants_worldwide575
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameQuentin
      • investigator1_middle_name
      • investigator1_family_nameAwori
      • investigator1_qualificationMBChB
      • investigator1_professional_addressABC Place, 2nd floor Waiyaki Way, Westlands, Nairobi
      • investigator1_telephone+254 722 912 616
      • investigator1_emailQAwori@engenderhealth.org
      • organisations_transferred_Yes
      • number_participantsPhase I - 230\nPhase II - 345
      • notification
      • approval_date15-04-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-01-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study is now approved
      • final_report<p>\n <strong>Phase 1: Simplifying the ShangRing Technique for Circumcision in Boys and Men: Use of the No-Flip Technique with Randomization to Removal at 7 Days vs. Spontaneous Detachment</strong></p>\n<p>\n Background</p>\n<p>\n Voluntary medical male circumcision is being rolled out to reduce HIV transmission in Sub-Saharan Africa. We assessed safety of the new no-flip ShangRing circumcision technique in males 10 years and older, and determined the clinical course and safety of spontaneous device detachment.</p>\n<p>\n Setting</p>\n<p>\n Two health facilities in Kenya.</p>\n<p>\n Methods</p>\n<p>\n We conducted a case series of no-flip ShangRing circumcision combined with a randomized controlled trial of removal 7 days post-circumcision vs. spontaneous device detachment. The primary outcome was safety of the no-flip technique based on moderate and severe adverse events (AEs). A main secondary outcome was clinical course and safety of spontaneous detachment.</p>\n<p>\n Results</p>\n<p>\n 230 men and boys were circumcised; 114 randomized to 7 day removal and 116 to spontaneous detachment. All circumcisions were successfully completed. There were 6 (5.3%) AEs in the 7-day group and 2 (1.7%) in the spontaneous group; with no significant differences when either were compared to historical data from Africa (p=.07 and p=.79, respectively). There was  no difference in AE rates (p=.169), visit day declared healed (p=.324) or satisfaction (p=.371) between randomization groups. 84 (72.4%) participants in the spontaneous group wore the ShangRing until it detached. The median days to detachment was 14.0 (IQR: 7-21, min-max: 5-35).</p>\n<p>\n Conclusions</p>\n<p>\n The no-flip technique and spontaneous detachment are safe, effective, and acceptable to males 10 years and older. Phimosis and penile adhesions do not limit successful ShangRing circumcision. A single device usable across ages would simplify services, supply chain management, training, and educational materials, and facilitate circumcision scale-up.</p>\n<p>\n <strong>Phase 2: Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial</strong></p>\n<div>\n Background</div>\n<div>\n The ShangRing is a disposable, collar clamp circumcision device pre-qualified for use</div>\n<div>\n in men and boys 13 years and above. It has been shown to be faster than conventional</div>\n<div>\n circumcision with comparable adverse event (AE) rates and high client satisfaction.</div>\n<div>\n The fear of pain during circumcision is an important barrier to uptake of voluntary</div>\n<div>\n medical male circumcision (VMMC). Use of topical anesthesia thus presents an</div>\n<div>\n opportunity to address this.</div>\n<div>\n  </div>\n<div>\n Objectives</div>\n<div>\n We sought to evaluate the safety, effectiveness and acceptability of the use of topical</div>\n<div>\n anaesthesia with ShangRing circumcision of men and boys 10 years of age and above.</div>\n<div>\n  </div>\n<div>\n Methods</div>\n<div>\n Participants were randomised 2:1 to receive topical or injectable anaesthesia. All</div>\n<div>\n participants underwent no-flip ShangRing circumcision. The primary outcome measure</div>\n<div>\n was pain. Secondary outcomes included ease of use of topical versus injectable</div>\n<div>\n anaesthesia, AEs and participant satisfaction.</div>\n<div>\n  </div>\n<div>\n Results</div>\n<div>\n Compared to the topical group, participants in the injectable group reported</div>\n<div>\n significantly more pain on administration of the anesthesia and at approximately 20</div>\n<div>\n minutes after the procedure. Sufficient anaesthesia with topical cream was not</div>\n<div>\n achieved in 21 (9.3%) cases and supplementary injectable anaesthesia was required.</div>\n<div>\n The AE rate was significantly (p<.01) lower in the topical (0%) vs. the injectable group</div>\n<div>\n (4.2%). The most common was pain during the post-operative period. All AEs were</div>\n<div>\n managed conservatively and resolved without sequeale. 96.7% of participants were</div>\n<div>\n satisfied with the appearance of the healed penis and 100% would recommend the</div>\n<div>\n ShangRing to others. All seven male circumcision providers involved in the study</div>\n<div>\n preferred topical to injectable anaesthesia.</div>\n<div>\n  </div>\n<div>\n Conclusions</div>\n<div>\n Our results demonstrate the safety, improved clinical experience, effectiveness, and</div>\n<div>\n acceptability of the use of topical anaesthesia in ShangRing circumcision using the noflip</div>\n<div>\n technique. Topical anaesthesia is an important alternative and has the potential to</div>\n<div>\n increase demand for VMMC while decreasing the risk of needlestick injuries.</div>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2018-10-10 18:29:03
      • created2015-01-19 09:07:49
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id257
        • application_id379
        • given_nameMark
        • middle_name
        • family_nameBarone
        • qualificationDVM, MS
        • professional_address440 Ninth Avenue, 12th Floor, New York, New York
        • telephone+1 212 561 8084
        • emailmbarone@engenderhealth.org
        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
    • SiteDetail(array)
      • 0(array)
        • id308
        • application_id379
        • county_id43
        • site_nameHoma Bay Level IV hospital
        • physical_addressHoma Bay town,
        • contact_details0723 886 261
        • contact_personDr. Raymond Otieno
        • site_capacity(null)
        • misc(null)
        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 1(array)
        • id309
        • application_id379
        • county_id3
        • site_nameVipingo Health Centre
        • physical_addressVipingo
        • contact_details0722 235 433
        • contact_personJudy Kinya
        • site_capacity(null)
        • misc(null)
        • created2015-01-19 11:11:35
        • modified2015-01-27 18:25:09
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
    • Sponsor(array)
      • 0(array)
        • id195
        • application_id379
        • sponsorEngenderHealth
        • sponsor_type(null)
        • contact_personMark Barone
        • address440 Ninth Avenue, New york
        • telephone_number+1 (206) 709-3100
        • fax_number
        • cell_number+1 (206) 709-3100
        • email_addressmbarone@engenderhealth.org
        • created2015-01-19 10:00:27
        • modified2015-01-27 18:25:09
      • 1(array)
        • id196
        • application_id379
        • sponsorWeill Cornell Medical College
        • sponsor_type(null)
        • contact_personProf. Phillip Li
        • address1300 York Avenue . New York, NY 10065
        • telephone_number+1 (212) 746-5454
        • fax_number
        • cell_number+1 646 341 0033
        • email_addresspsli@med.cornell.edu
        • created2015-01-19 11:48:26
        • modified2015-01-27 18:25:09
  • 3(array)
    • Application(array)
      • id376
      • user_id255
      • trial_status_id6
      • abstract_of_study<p>\n <strong><u> SYNOPSIS</u></strong><br />\n Study title<br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n Trial Design Immediate vs delayed study<br />\n <u>Study Population</u><br />\n HIV-1/2 negative, females at low risk of HIV aged 18-50 years of<br />\n age.<br />\n Planned Sample Size 44<br />\n Planned Trial Period 13 months after recruitment<br />\n Primary Outcome To measure cervical mucosal immune activation after VZVvaccination<br />\n in the context of VZV-effector responses.<br />\n <u>Secondary Objective</u><br />\n To measure the effector VZV-specific CD8+ T cells at the rectal<br />\n mucosa after VZV vaccination;<br />\n To compare the immune activation observed in mucosal tissues<br />\n and in blood.<br />\n <u>Primary Endpoint</u><br />\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.<br />\n <u>Secondary endpoints</u><br />\n An increase in the percentage of VZV-specific CD8+T cells at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. This increase must be significantly different<br />\n from the change observed in the same period for the delayed group<br />\n in order to be considered associated to vaccination.<br />\n To compare the expression of co-receptors and activation markers<br />\n such as CCR5, α4β7, CD38, CD69 and HLA-DR in blood and<br />\n cervical CD4+T cells at 3 months after immunization with<br />\n varicella vaccine.<br />\n Investigational<br />\n Medicinal Product<br />\n Zostavax®<br />\n KAVI-VZV-001 Version 2.0 (01 September 2014) Page 9 of 49<br />\n Dose Zostavax® >19,400 PFU (Z)<br />\n Route Subcutaneous needle injection<br />\n <u>Study Design</u><br />\n Vaccination Period<br />\n Group No. Wk 0 Wk 12<br />\n Immediate 22 Z -<br />\n Delayed 22 - Z<br />\n <u>Follow-Up Duration</u><br />\n After the vaccination with Zostavax®, the delayed groups will be<br />\n followed-up for 9 months and the immediate groups for 12<br />\n months.<br />\n Trial Sponsor University of Toronto, Canada</p>\n
      • study_title<p style=\"text-align: justify;\">\n <br />\n <u><strong>Study title</strong></u><br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n  </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/01/02
      • version_noVersion No: 2.0 (01 September 2014)
      • date_of_protocol01-09-2014
      • study_drugVaricella Zoster Virus vaccine Zostavax® (Merck)
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameZostavax®
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressEmutisya@kaviuon.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKAVI-Institute of Clinical Research (KAVI-ICR) University of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya
      • declaration_date115-01-2015
      • declaration_principal_investigatorProfessor Walter Jaoko, MB, ChB, MTropMed, PhD, Site Principal Investigator
      • declaration_date215-01-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. Healthy females, as assessed by a medical history, physical examination and<br />\n laboratory tests, with no chronic medical condition;<br />\n 2. Aged at least 18 years on the day of screening and no greater than 50 years on the day<br />\n of the first vaccination.<br />\n 3. VZV-seropositive, as assessed by the VIDAS assay.4. Ability to comply with the study requirements and available for follow-up for the<br />\n planned duration of the study.<br />\n 5. In the opinion of the Principal Investigator or designee, the volunteer has understood<br />\n the information provided and signed the consent document.<br />\n 6. Willing to undergo HIV testing, HIV counselling and receive HIV test results.<br />\n 7. For women with potential to become pregnant, willing to use effective contraception<br />\n or barrier methods to avoid pregnancy during the study (spermicides or chemicals are<br />\n not allowed).<br />\n  </p>\n
      • principal_exclusion_criteria<p>\n Any relevant abnormality on history or examination including history of tuberculosis,<br />\n immunodeficiency or autoimmune disease, or use of systemic corticosteroids,<br />\n immunosuppressive, antiviral, anticancer or other medication that, in the opinion of the<br />\n Principal Investigator or designee, is clinically significant. (Note: use of inhaled steroids for<br />\n asthma or use of topical steroids for localized skin conditions will not exclude a volunteer<br />\n from participation) and/or:<br />\n 1. A high risk for HIV-acquisition defined by the experience of any of the follow<br />\n situations:<br />\n a) Had unprotected vaginal or anal sex with a known HIV-1-infected person, a<br />\n person known to be at high risk for HIV or a casual partner (i.e., no continuing,<br />\n established relationship) within the previous 6 months;<br />\n b) Engaged in sex work for money or drugs within the previous 6 months;<br />\n c) Used injection drugs;<br />\n d) Abuse of illicit or prescribed drugs, including alcohol;<br />\n e) Acquired one of the following sexually transmitted infection: chlamydia,<br />\n gonorrhoea and syphilis in the last 12 months;<br />\n f) More than 1 sexual partner within the last 6 months;<br />\n g) New sexual partner within the last 3 months.<br />\n 2. Persistent or recurrent bacterial vaginosis or vaginal candidiasis unresponsive to<br />\n therapy (2 consecutive attempts by study team).<br />\n 3. Confirmed HIV-1 or HIV-2 infection.<br />\n 4. Any clinically significant acute or chronic medical condition that is considered<br />\n progressive or, in the opinion of the Principal Investigator or designee, would make<br />\n the volunteer unsuitable for the study (active or underlying diabetes, gastrointestinal,<br />\n cardiovascular, malignancy, neurological, psychiatric, metabolic, renal, hepatic,<br />\n respiratory, auto-immune diseases, psoriasis, primary and acquired immunodeficiency<br />\n KAVI-VZV-</p>\n<p>\n status and rectal problems).<br />\n 5. Any of the following abnormal laboratory parameters except that one abnormal<br />\n laboratory test may be repeated once if thought to be due to a temporary condition:<br />\n Haematology<br />\n a) Haemoglobin < 9.0 g/dl<br />\n b) Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /l, ≥ 550 /l)<br />\n Coagulation<br />\n - INR <1.0 or >1.5<br />\n 6. Evidence of coagulopathy demonstrated by a reduced level of platelets or a history of<br />\n 3 or more episodes of uncontrolled bleeding from their mouth, nose or other mucous<br />\n membrane (marked by excessive bleeding of more than 30 min).<br />\n 7. A positive pregnancy test or breast-feeding at screening; for the participants with<br />\n reproductive potential, unwilling to use an effective method of preventing pregnancy<br />\n during the study.<br />\n 8. Receipt of vaccine within the previous 2 months or planned receipt at any time until 6<br />\n months after vaccination with Zostavax®.<br />\n 9. Receipt of blood transfusion or blood products within the previous 6 months.<br />\n 10. Participation in another clinical trial currently or within the previous 3 months.<br />\n 11. History of severe or very severe local or systemic reactogenicity events after<br />\n vaccination, or history of severe or very severe allergic reactions.<br />\n 12. History of toxic shock syndrome.<br />\n 13. Confirmed diagnosis of acute or chronic hepatitis B virus infection (spontaneous<br />\n clearance leading to natural immunity, indicated by antibodies to core + antigens, is<br />\n not an exclusion criterion); confirmed diagnosis of hepatitis C virus infection.<br />\n 14. Immunosuppressive medications 30 days before or during the study period.<br />\n 15. History of anaphylactic/anaphylactoid reaction to neomycin (each dose of<br />\n reconstituted vaccine contains trace quantities of neomycin).<br />\n 16. Major psychiatric illness including any history of schizophrenia or severe psychosis,<br />\n bipolar disorder, suicidal attempt or ideation in the previous 3 years.<br />\n 17. Contra-indication for undergoing a biopsy due to bleeding diathesis, haemorrhoids,<br />\n mucosal infection at the biopsy site, medication that interfere with clotting (e.g.<br />\n warfarin or heparin) – both clinical and laboratory.<br />\n 18. Any other reason as determined by the Principal Investigator</p>\n
      • primary_end_points<p>\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifycharacterization of mucosal immune response.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n Name</p>\n </td>\n <td>\n <p>\n Designation</p>\n </td>\n <td>\n <p>\n Qualifications</p>\n </td>\n <td>\n <p>\n Years in research</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Omu Anzala</p>\n </td>\n <td>\n <p>\n Co-Investigator</p>\n </td>\n <td>\n <p>\n MBChB, diploma epidemiology, PhD medical microbiology and infectious disease, post doc fellow molecular immunology group institute of molecular medicine oxford university</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Walter Jaoko</p>\n </td>\n <td>\n <p>\n Principal Investigator</p>\n </td>\n <td>\n <p>\n MBChB, MSc tropical medicine, diploma research methodology, PhD medical mirobiology</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Kirana Bhatt</p>\n </td>\n <td>\n <p>\n Consultant Physician</p>\n </td>\n <td>\n <p>\n MBChB, MMed internal medicine, MSc clinical tropical medicine, PhD</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gina Ouattara</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB</p>\n </td>\n <td>\n <p>\n 5.5</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gaudensia Mutua</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB, MPH</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Emmanuel Museve</p>\n </td>\n <td>\n <p>\n Study clinician</p>\n </td>\n <td>\n <p>\n Diploma clinical medicine and surgery</p>\n </td>\n <td>\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jacquelyn Nyange</p>\n </td>\n <td>\n <p>\n Study coordinator - regulatory</p>\n </td>\n <td>\n <p>\n KRN, BA psychology, MSc clinical psychology</p>\n </td>\n <td>\n <p>\n 11</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Elizabeth Mutisya</p>\n </td>\n <td>\n <p>\n Study coordinator – clinic level</p>\n </td>\n <td>\n <p>\n KRCHN, BA psychology and sociology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Hilda Ogutu</p>\n </td>\n <td>\n <p>\n Senior study nurse</p>\n </td>\n <td>\n <p>\n KRM, KRCHN, BScN</p>\n </td>\n <td>\n <p>\n 13</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Ndambuki</p>\n </td>\n <td>\n <p>\n Study nurse</p>\n </td>\n <td>\n <p>\n KRCHN, HND counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Roselyne Malogo</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n KRCHN, certificate in conflict resolution, BA community development</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Mahira</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n ECN, diploma in counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Bashir Farah</p>\n </td>\n <td>\n <p>\n Laboratory manager</p>\n </td>\n <td>\n <p>\n HND virology, MSc Virology</p>\n </td>\n <td>\n <p>\n 18</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jackton Indagasi</p>\n </td>\n <td>\n <p>\n Laboratory quality assurance manager</p>\n </td>\n <td>\n <p>\n PGD infectious disease, MSc infectious disease</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Robert Langat</p>\n </td>\n <td>\n <p>\n Laboratory and site Safety officer</p>\n </td>\n <td>\n <p>\n BSc medical laboratory technology</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Simon Ogolla</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n HND microbiology</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Irene Mwangi</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n Diploma laboratory technology, BSc laboratory technology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Ruth Chirchir</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n BSc biological sciences</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Moses Muriuki</p>\n </td>\n <td>\n <p>\n Data/IT Manager</p>\n </td>\n <td>\n <p>\n BSc software engineering</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Laura Lusike</p>\n </td>\n <td>\n <p>\n Data assistant</p>\n </td>\n <td>\n <p>\n BA home economics</p>\n </td>\n <td>\n <p>\n 14</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Other staff:</p>\n <p>\n Administrative, Finance and support staff</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n Site facilities:<br />\n - Reception<br />\n - Waiting room for volunteers<br />\n - Counseling rooms - 2<br />\n - Patient examination rooms – 3<br />\n - Study records filing room – limited access using swipe card<br />\n - Laboratories – swipe access<br />\n o safety laboratory<br />\n o immunology laboratory<br />\n - Data room – limited access with swipe card<br />\n o Pre – archive room – swipe card access<br />\n o Data entry computers – 4<br />\n o Online and offline data entry capabilities<br />\n o Data faxing<br />\n o Internet – upload and download bandwidth of 1MB/second and backup modems from mobile service providers<br />\n o Backup UPS of 4 – 6 hours and backup generator<br />\n - Kitchenette – for staff and volunteer refreshments<br />\n - Meeting room<br />\n Emergency facilities:<br />\n - One of the patient examination rooms is equipped as an emergency room with oxygen tank and mask, suction pump machine with suction tubes, defibrillator, nebulizer, laryngoscope, endotracheal tubes, airway, adult ambu bag and mask, giving sets.<br />\n - Emergency stretcher<br />\n - Emergency drugs in stock –<br />\n o Parenteral - hydrocortisone, adrenaline, paracetamol, hyosine, atropine, lidocaine, lignocaine, aminophylline, sodium bicarbonate, metoclopramide, diazepam, chlorpheniramine, calcium gluconate,<br />\n o Salbutamol nebulizer solution<br />\n o IV fluids – 5% dextrose, 50% dextrose, normal saline<br />\n o Post exposure prophylaxis – combivir and kaletra<br />\n - Patients can then be transferred to Kenyatta National Hospital emergency department or admitted to the wards for further care.</p>\n
      • other_details_explanation<p>\n In this trial we ai to investigate the potentail of using varicella-zoster virus (VZV) as a vector for an hiv-vaccine by first characterising the mucosal immune response induced by VZV vaccination. As we intend to conduct the future VZV-HIV phase 1 clinical trial ( with VZV carrying HIV genes) in kenya it is important that the study that sets the basis for this future be also conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Toronto research ethics committee, !st Dec 2014.</p>\n
      • other_details_regulatory_approved<p>\n KNH/UON Ethics research committee.</p>\n<p>\n Approval date:23rd oct 2014.</p>\n<p>\n Sites: KAVI-ICR, Nairobi Kenya.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration13 months after enrollment.
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI-INSTITUTE OF CLINICAL RESEARCH (KAVI-ICR)
      • single_site_physical_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya.
      • single_site_contact_personProfessor Walter Jaoko,
      • single_site_telephone+254-2-2717694/+254727555254
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listKENYA\nCANADA
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide44
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf Walter Jaoko
      • investigator1_middle_name
      • investigator1_family_name Jaoko
      • investigator1_qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
      • investigator1_professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
      • investigator1_telephone+254-2-2717694/+254727555254
      • investigator1_emailwjaoko@kaviuon.org
      • organisations_transferred_Yes
      • number_participants44
      • notification<p>\n none.</p>\n
      • approval_date10-03-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-01-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-04-26 16:23:36
      • created2015-01-15 09:38:39
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id256
        • application_id376
        • given_nameProf Walter Jaoko
        • middle_name
        • family_nameJaoko
        • qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
        • professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
        • telephone+254-2-2717694/+254727555254
        • emailwjaoko@kaviuon.org
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
    • SiteDetail(array)
      • 0(array)
        • id307
        • application_id376
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id194
        • application_id376
        • sponsorUniversity of Toronto
        • sponsor_type(null)
        • contact_personDr. Kelly S. MacDonald, MD, FRCPC, Chief Investigator
        • addressDepartment of Medicine and Immunology University of Toronto 1 King’s College Circle Medical Sciences Building, Room 6360 Toronto ON, M5S 1A8 Canada.
        • telephone_number(416) 946-3733
        • fax_number(416) 978-8765
        • cell_number(416) 946-3733
        • email_addresskelly.macdonald@utoronto.ca
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
  • 4(array)
    • Application(array)
      • id354
      • user_id229
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background</strong>: WHO guidelines recommend second-line antiretroviral therapy for adults consisting of two NRTIs + a ritonavir-boosted protease inhibitor (PI); atazanavir plus ritonavir (ATV+RTV) or lopinavir (LPV)/RTV are the preferred boosted PI options. Several studies have been conducted or are currently underway to investigate novel treatment strategies (i.e. NRTI-sparing regimens) in patients requiring second-line ART. <span style=\"line-height: 115%; font-family: Arial, sans-serif; font-size: 9pt;\">There are currently no studies ongoing to explore the potential option of PI-sparing second-line ART. </span>Further data is needed on best treatment options for HIV-1 infected people who have virological failure with this first-line regimen. This study compares a second-line regimen of DTG (dolutegravir) plus two NRTIs with a WHO-recommended regimen of LPV/RTV with two NRTIs.</p>\n<p>\n <strong>Objectives</strong>: The main aim of this study is to demonstrate non-inferior antiviral activity at 48 weeks of a DTG containing regimen (DTG 50 mg once daily + two NRTIs) compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV + two NRTIs, in HIV-1 infected patients failing first line therapy.</p>\n<p>\n <strong>Methods</strong>: This study is a Phase IIIb, randomised, open-label, active-controlled, multicenter, parallel group, non-inferiority study. Approximately 612 adult patients with confirmed virologic failure (HIV-1 RNA more than or equal to 400 c/mL on two occasions) on their first antiretroviral regimen consisting of one NNRTI + two NRTIs will be recruited in 13 countries. In Kenya, there will be two sites: the Kenya Medical Research Institute (KEMRI) Research Care and Training Programme, Family AIDS Care and Education Programme (FACES) based at the Centre for Microbiology Research at Lumumba health centre in Kisumu County, and the KEMRI-FACES at the Centre for Respiratory Diseases Research (CRDR), Nairobi. Participants will be randomised 1:1 to receive DTG 50 mg once daily or LPV/RTV (800/200 mg once daily or 400/100 mg twice daily), each added to an investigator selected background regimen consisting of two NRTIs with at least one fully active NRTI.</p>\n<p>\n <strong>Analysis</strong>: The primary analysis at Week 48 will take place after the last subject completes 52 weeks on therapy (Day 1 to Week 48 plus a 4-week treatment extension). An interim analysis and data cut will be conducted after the last subject completes 24 weeks on therapy, with the intent to provide an earlier assessment of efficacy to inform the Sponsor and clinicians.</p>\n
      • study_title<p>\n A Phase 3b, randomised, open-label study of the antiviral activity and safety of dolutegravir compared to lopinavir/ritonavir both administered with dual nucleoside reverse transcriptase inhibitor therapy in HIV-1 infected adult subjects with treatment failure on first line therapy</p>\n
      • laymans_summary(null)
      • short_titleDolutegrAvir With NRTIs as second-line treatment (DAWNING)
      • protocol_noECCT/15/06/03
      • version_no01
      • date_of_protocol30-04-2014
      • study_drugDolutegravir 50 mg tablets; Lopinavir/ritonavir tablets
      • disease_conditionHIV-1 AIDS
      • 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_nameDolutegravir
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgodfrey.m.nyakaya@gsk.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_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
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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)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantGodfrey Nyakaya
      • declaration_date116-06-2015
      • declaration_principal_investigatorDr. William Mwiti, Medical Director- Kenya, GlaxoSmithKline, Likoni Rd, Nairobi
      • declaration_date216-06-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. Signed and dated written Informed Consent obtained prior to screening.</p>\n<p>\n 2. HIV-1 infected men or women ≥18 years.</p>\n<p>\n • Women of childbearing potential must use adequate contraception (see Protocol Section 4.2).</p>\n<p>\n 3. On a first-line treatment regimen consisting of an NNRTI plus two NRTIs for at least 6 months and is currently experiencing virologic failure:</p>\n<p>\n • HIV-1 RNA ≥400 c/mL at Screening + at least one previous HIV-1 RNA result of ≥400 c/mL within the 3 months prior to Screening.</p>\n<p>\n • If HIV-1 RNA within 3 months prior to Screening not available, a second HIV-1 RNA must be performed during the Screening period and have results of ≥400 c/mL.</p>\n<p>\n 4. At least one fully active agent within the dual-NRTI background regimen for second line treatment. Fully active: no evidence of full or partial resistance as per Screening genotypic resistance report.</p>\n<p>\n 5. Is PI-naïve and INI-naïve, defined as no prior or current exposure to any PI or INI.</p>\n
      • principal_exclusion_criteria<p>\n 1. Women who are breastfeeding. </p>\n<p>\n 2. Active CDC Category C disease, except:</p>\n<p>\n • cutaneous Kaposi’s sarcoma not requiring systemic therapy</p>\n<p>\n • historic or current CD4+ cell levels <200 cells/mm3. </p>\n<p>\n 3. Severe hepatic impairment (Child-Pugh Class C). </p>\n<p>\n 4. Unstable liver disease (Ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (except Gilbert's syndrome, asymptomatic gallstones).</p>\n<p>\n 5. Anticipated need for HCV therapy (during the Randomised Phase). </p>\n<p>\n 6. History or presence of allergy or intolerance to study drugs or their components or drugs of their class. </p>\n<p>\n 7. Ongoing malignancy (other than specified localized malignancies, e.g. Kaposi’s sarcoma, cervical intraepithelial neoplasia). </p>\n<p>\n 8. In the investigator’s opinion, significant suicidality risk.</p>\n<div>\n 9. HIV immunotherapeutic vaccine within 90 days of Screening</div>\n<div>\n  </div>\n<div>\n 10. Radiation, cytotoxic chemotherapy or systemically administered immunomodulators within 28 days of Screening</div>\n<div>\n  </div>\n<div>\n 11. Treatment with any agent, other than licensed ART as allowed per inclusion criteria, with documented activity against HIV-1 in vitro/vivo within 28 days of first dose of IP. </div>\n<div>\n • Exception: entecavir, in appropriate clinical situations, for treatment of hepatitis B (e.g. prior intolerance to TDF, viral resistance to 3TC /FTC) after discussion and agreement between investigator and medical monitor.</div>\n<div>\n  </div>\n<div>\n 12. Exposure to any experimental drug or vaccine within 28 days or 5 half-lives  of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to first dose of IP</div>\n<div>\n  </div>\n<div>\n <div>\n 13. Primary viral resistance to PIs or INIs based on the presence of any major resistance-associated mutation.</div>\n <div>\n  </div>\n <div>\n 14. Subject’s virus does not yield results using genotype at Screening.</div>\n <div>\n  </div>\n <div>\n 15. Any verified Grade 4 laboratory abnormality with the exception of Grade 4 triglyceride abnormalities.</div>\n <div>\n  </div>\n <div>\n 16. Any acute lab abnormality which would exclude subject’s participation in a study of an investigational drug</div>\n <div>\n  </div>\n <div>\n 17. ALT ≥5xULN or ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin).</div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<p>\n The proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure) for the intent-to-treat exposed (ITT-E) population.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Please refer to appendix I: 'Capacity of Sites DTG 200304' under 'Notifications' section for a description of sites' capacity.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The trial will be conducted in 13 countries globally. This study is aimed at low-income and middle-income countries where the WHO HIV-treatment guidelines are followed. Kenya follows the WHO treatment guidelines. Kenya has a HIV-1 burden with relatively high rates of resistance to WHO recommended first line regimen. We completed country feasibility that confirmed that Kenya has the suitable patient population.The data collected from Kenya is aimed at supporting the registration of a new INI regimen in the region.</p>\n
      • other_details_regulatory_notapproved<p>\n The table below provides the name of other regulatory authorities to which applications to conduct this trial have been submitted, but approval not yet granted.</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"1\" style=\"width:500px;\" width=\"500\">\n <tbody>\n <tr>\n <td>\n <p>\n <strong>Name of competent Authority</strong></p>\n </td>\n <td>\n <p>\n <strong>Submission Date</strong></p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Pharmacy and Poisons Board, Kenya</p>\n </td>\n <td>\n <p>\n   June, 2015</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n The table below summaries the number of sites planned in which the Regulatory Authorities have approved this trial.</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"1\" height=\"556\" width=\"802\">\n <tbody>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Name of Competent Authority</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n Date of approval</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n Number of planned centres</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n ANMAT, Argentina</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 11^th November, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n ISP, Chile</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 22^nd October, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Roszdrav Nadzor, Russia</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 11^th August, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Medicines Control Council, South Africa</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 23^rd September, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n General Directorate of Pharmaceuticals, Devices and Drugs, Peru</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 28^th November, 2014</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 6</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n COFEPRIS, Mexico</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 8th January 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n INVIMA (National Institute for Drug and Food Surveillance), Colombia</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 15th January 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n China</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 13^th February 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Romania</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 5^th February 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Thailand</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 4^th February 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 5</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Ukraine</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 22^nd May 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:270px;\">\n <p>\n Brazilian Health Surveillance Agency (Anvisa), Brazil</p>\n </td>\n <td style=\"width:181px;\">\n <p>\n 8^th May 2015</p>\n </td>\n <td style=\"width:140px;\">\n <p>\n 4</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration52 weeks.
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorLopinavir/ritonavir (Kale
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyDolutegravir tablets and Kaletra (LPV/r) tablets are administered with 2 background investigator-selected locally approved NRTIs, with at least one fully active NRTI within the background regimen based on Screening genotype resistance results.
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states13
      • number_of_sites2
      • multi_country_listArgentina, Brazil, Chile, China, Colombia, Kenya, Mexico, Peru, Romania, Russia, South Africa, Thailand, Ukraine
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKEMRI CRDR Nairobi: 20 participants,\nKEMRI FACES St. Lumumba Health center Kisumu: 10 participants
      • total_participants_worldwide612
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr. William
      • investigator1_middle_name
      • investigator1_family_nameMwiti
      • investigator1_qualificationMB.ChB,
      • investigator1_professional_addressGlaxoSmithKline, Likoni Rd, P. O. Box 78392 - 00507, Nairobi, Kenya
      • investigator1_telephone+254 20 69 33 329, +254 700 470466, +254 721 291882
      • investigator1_emailwilliam.m.mwiti@gsk.com
      • organisations_transferred_Yes
      • number_participants30
      • notification<p>\n For any information, queries or enquiries please contact:</p>\n<p>\n Godfrey Nyakaya, GSK Kenya, Clinical Research Associate, Email: <strong><a href=\"mailto:jacqueline.r.wanja@gsk.com\">godfrey.m.nyakaya@gsk.com</a> </strong>, Mobile: +254 734 227505, Address: GlaxoSmithKline Kenya, P. O. Box 78392 - 00507, Likoni Rd, Nairobi</p>\n<p>\n Or:</p>\n<p>\n Dr. William Mwiti, GSK Kenya, Medical Director - Kenya, Email: <strong><a href=\"mailto:william.m.mwiti@gsk.com\">william.m.mwiti@gsk.com</a> </strong>, Mobile: +254 700 470466, +254 721 291882, Office: +254 20 69 33 329, Address: GlaxoSmithKline Kenya, P. O. Box 78392 - 00507, Likoni Rd, Nairobi</p>\n
      • approval_date29-07-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-06-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The Site enrolled 29 Study participants: 15 in DTG Arm and 14 on LPV/RTV.</p>\n<ul>\n <li>\n 5 participants were withdrawn before they completed the study due to various reasons:</li>\n <li>\n 3 due to Viral rebound</li>\n <li>\n 1 died due to meningoencephalitis</li>\n <li>\n 1 due to Severe Anaemia secondary to AZT</li>\n <li>\n The other 24  participants completed the study period but 14 on DTG Arm continued with the study until June when they were transferred back to NASCOP when the drug was available.</li>\n</ul>\n
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2019-07-19 10:14:25
      • created2014-11-27 16:14:22
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id249
        • application_id354
        • given_nameDr. Evans
        • middle_nameInyangala
        • family_nameAmukoye
        • qualificationMB.ChB, M.Med (Paed)
        • professional_addressCenter for Respiratory Diseases Research, CRDR, KEMRI, P.O. Box 47855 – 00100, Nairobi
        • telephone+254 722634383
        • emailamukoye@gmail.com
        • created2014-11-27 16:38:11
        • modified2015-06-16 14:18:21
      • 1(array)
        • id251
        • application_id354
        • given_nameDr. Maricianah
        • middle_nameAtieno
        • family_nameOnono
        • qualificationMB.ChB, Certificate (Research Methods), M.Sc (Clinical Research), Fogarty Fellowship (Global Health)
        • professional_addressKEMRI-Research Care and Training Program (RCTP), Family AIDS Care and Education Services (FACES), Lumumba health centre, Off Agoi Road, PO BOX 614 - 40100, Kisumu
        • telephone+254 732 39 09 92
        • emailmonono@kemri-ucsf.org
        • created2014-11-27 16:38:11
        • modified2015-06-16 14:18:21
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        • id300
        • application_id354
        • county_id47
        • site_nameCenter for Respiratory Diseases Research, CRDR, KEMRI, Nairobi
        • physical_addressP.O. Box 47855 – 00100, Nairobi
        • contact_detailsamukoye@gmail.com, Mobile: +254 722 634383
        • contact_personDr. Evans Inyangala Amukoye
        • site_capacity(null)
        • misc(null)
        • created2014-11-27 16:38:11
        • modified2015-06-16 14:18:21
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id302
        • application_id354
        • county_id42
        • site_nameKEMRI-Research Care and Training Program (RCTP), Family AIDS Care and Education Services (FACES), Lumumba health centre
        • physical_addressOff Agoi Road, PO BOX 614 - 40100, Kisumu
        • contact_detailsmonono@kemri-ucsf.org, Mobile: +254 732 390992
        • contact_personDr. Maricianah Atieno Onono
        • site_capacity(null)
        • misc(null)
        • created2014-11-28 16:47:52
        • modified2015-06-16 14:18:21
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id189
        • application_id354
        • sponsorGlaxoSmithKline Kenya Ltd, Nairobi
        • sponsor_type(null)
        • contact_personGodfrey Nyakaya/ Dr. William Mwiti
        • addressGSK, Likoni Road, P. O. Box 78392 - 00507, Nairobi
        • telephone_number+254 20 69 33 200/ 20 69 33 329
        • fax_number
        • cell_number+254 734 227505, +254 700 470466
        • email_addressgodfrey.m.nyakaya@gsk.com
        • created2014-11-27 16:38:11
        • modified2015-06-16 14:18:21
      • 1(array)
        • id198
        • application_id354
        • sponsorViiV Healthcare
        • sponsor_type(null)
        • contact_personNassrin Payvandi
        • address980 Great West Road, Brentford, Middlesex, TW8 9GS, UK
        • telephone_number+44 (0)20 8380 6218
        • fax_number
        • cell_number+44 (0) 7717 800810
        • email_addressnassrin.x.payvandi@viivhealthcare.com
        • created2015-02-02 09:43:39
        • modified2015-06-16 14:18:21
• page_options(array)
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App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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• 1/var/www/html/ctr/lib
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Included Files

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    • 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