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• applications(array)
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    • Application(array)
      • id1398
      • user_id81
      • trial_status_id1
      • abstract_of_study<p>\n The Severe Malaria Africa – A Consortium for Research and Trials (SMAART) aims to significantly improve outcomes for severe malaria through enhanced and accelerated research initiatives. SMAART serves as an efficient operational platform for coordinating future research, enabling continuous updates to disease definitions and treatment guidelines based on the latest evidence. During its 2-day inception meeting, SMAART assembled a multidisciplinary team including scientists from major Wellcome Trust programs (KEMRI in Kenya, Malawi-Liverpool-Wellcome Trust Unit in Malawi, Mahidol Oxford Tropical Medicine Research Unit in Thailand), clinical trial experts (MRC CTU at UCL), and African clinician scientists from multiple countries.</p>\n<p>\n The meeting focused on establishing the current burden of severe malaria through literature review, updating our understanding of the disease's clinical spectrum, identifying accurate diagnostic tools, and setting best practices to address research gaps. Key discussions revolved around refining practice guidelines in response to challenges like artemisinin resistance and persistently high mortality rates despite effective antimalarial treatments. The meeting also laid out plans for future clinical trials, emphasizing pathophysiological research and innovative trial methodologies.</p>\n<p>\n Despite various supportive therapies being explored through ongoing and planned clinical trials, the evidence remains sparse, underlining the urgent need for more comprehensive studies. The consortium stressed the necessity of an adaptive trial platform to properly evaluate potential beneficial adjunctive therapies and identified high-priority risk factors and interventions for a Phase II platform trial aimed at improving short and long-term outcomes.</p>\n<p>\n This structured approach aims to address severe malaria with targeted treatments and innovative research methodologies, with each intervention's background, justification, and rationale detailed in specific appendix protocols.</p>\n
      • study_title<div>\n Severe Malaria A Research and Trials consortium - Multisite Adaptive Platform trial</div>\n
      • laymans_summary<div>\n Children with severe malaria come to hospital very sick and need urgent care. Despite the introduction of the malaria vaccine in some areas of Africa and increased bednet use, severe malaria is still causing child deaths and hospitalisations. Even on the best anti-malarial treatments many African children with severe malaria have poor outcomes with including deaths which tend to occur on the first day of arrival to hospital. One of the bad things that happen in severe malaria is that red blood cells that are infected with malaria parasites stick to the very deep parts of our blood vessels. This occurs throughout the body and affects vital places such as the brain or kidneys. Thus, children come to hospital with different symptoms such as in a coma or with fits or with anaemia. They will be treated immediately with anti-malarials and may also receive antibiotics. Other treatments targeted at symptoms or specific areas of the body may also help them recover (called adjunctive therapy).</div>\n<div>\n The World Health Organisation has developed guidelines for treatment of severe malaria but much of the information used to develop the recommendations on adjunctive therapy are based on expert opinion and not data from clinical trials and studies which are a better source of evidence. The SMAART-MAP trial aims to identify adjunctive therapies that will help children with severe malaria get better faster in the short term (within 3 days of coming to hospital) and that could then be studied further in larger numbers to see if they are able to reduce the number of children who die or return to hospital.</div>\n<div>\n The trial has been designed to look at the impact of these adjunctive therapies on different symptoms or body areas. In the trial these different areas are called ‘domains’. One adjunctive therapy will be investigated within each domain of the trial. It is called an adaptive trial as new domains can be added to the structure of the trial after it has started, and all domains have some joint processes and will be run by the same staff. This document is the master protocol which outlines those joint processes and explains the main objective of the trial. Appendices describe the adjunctive therapies within each domain in more detail.</div>\n<div>\n A computer programme will assign a child to receive either the adjunctive treatment or the standard of care at that site within a domain at random (like the flip of a coin). Each child can only be enrolled to one domain and thus possibly receive one adjunctive treatment through the trial. Each child will be monitored through bedside observations and depending on the domain they may need some additional tests. This information will help us compare how children receiving the adjunctive therapy and receiving standard of care are responding to their treatment.</div>\n
      • short_titleSMAART-MAP trial
      • protocol_noECCT/24/04/03
      • version_no1.02
      • date_of_protocol09-02-2024
      • study_drugSMAART_MAP Trial_(Levetiracetam,Paracetamol and Blood products\' (whole blood and Package Cells)
      • disease_conditionSevere Malaria
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameParacetamol and Levetiracetam
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressCGMRCCSC@kemri-wellcome.org
      • applicant_covering_letter1
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      • applicant_detailed_budget1
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      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantEmmanuel Oguda
      • declaration_date107-08-2024
      • declaration_principal_investigatorProf.Kathryn Maitland
      • declaration_date207-08-2024
      • placebo_presentNo
      • study_objectives<p>\n The SMAART-MAP trial aims to identify promising adjunctive therapies for advancement into a comprehensive Phase III trial focused on severe malaria with an emphasis on mortality outcomes. Utilizing an adaptive platform design, the trial is structured to incorporate multiple domains, enabling the evaluation of various adjunctive therapies across diverse clinical manifestations of severe malaria efficiently.</p>\n<p>\n <strong>Primary Objective</strong></p>\n<ul>\n <li>\n The primary objective is to evaluate the therapeutic efficacy of each intervention within its respective domain. This evaluation will utilize early indicators such as biomarkers or clinical assessments conducted within 24-72 hours post-intervention.</li>\n</ul>\n<p>\n <strong>Secondary Objectives</strong></p>\n<ul>\n <li>\n To determine the impact of the interventions on clinical outcomes, including readmission rates and mortality, assessed at 28 days and 90 days following randomization.</li>\n <li>\n To evaluate the incidence and severity of Grade 3 or 4 adverse events, as well as any adverse events associated with the interventions or their comparators.</li>\n <li>\n To explore the effects of defined severe malaria criteria, specifically platelet counts ≤150,000/μL and plasma pfHRP2 concentrations ≥800 ng/mL, on the differentiation between randomized groups.</li>\n <li>\n In a sub study, to assess the performance characteristics of a point-of-care (POC) pfHRP2 test in comparison with quantitative plasma pfHRP2 measurements.</li>\n</ul>\n<p>\n These objectives are designed to guide the systematic exploration and evaluation of adjunctive therapies in the treatment of severe malaria, thereby contributing to improved treatment strategies and outcomes.</p>\n
      • principal_inclusion_criteria<p>\n Eligibility criteria for SMAART-MAP (all domains)</p>\n<ol>\n <li>\n Aged >3 months and <12 years</li>\n <li>\n Admitted to the paediatric ward in the last 24 hours at screening</li>\n <li>\n Current or recent evidence of malaria (slide or rapid diagnostic test (RDT) positive in this admission)</li>\n <li>\n Guardian willing to provide consent</li>\n</ol>\n<div>\n <strong>Additional domain-specific inclusion criteria.</strong></div>\n<div>\n <div>\n Severe Anaemia Domain</div>\n <ol>\n <li>\n Hb <6g/dl</li>\n <li>\n One or more or the following severity signs: Hb<4g/dl, prostration, impaired consciousness, respiratory distress, history of passing red or coca-coloured urine in this illness</li>\n </ol>\n</div>\n<p>\n Cerebral Malaria Domain (EITHER)</p>\n<ol>\n <li>\n One or more reported seizures in the current episode of illness and altered consciousness (BCS≤4) at screening OR</li>\n <li>\n Presence of coma (BCS ≤2) at screening regardless of history.</li>\n</ol>\n<p>\n Renal function Domain</p>\n<ol>\n <li>\n Creatinine >1.5xULN on point-of-care assay or laboratory test at screening</li>\n <li>\n Meet one of the current WHO severity criteria (clinical or laboratory (where these tests are done routinely)) (Group 1 and 2 from the recent WHO reclassification of severe malaria)</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Domains specific exclusion criteria.</p>\n<p>\n <strong>Severe Anaemia Domain</strong></p>\n<ol>\n <li>\n Known congenital or valvular heart disease (not surgically corrected)</li>\n</ol>\n<p>\n <strong>Cerebral Malaria Domain</strong></p>\n<ol>\n <li>\n Received an anticonvulsant within 6 hours of screening or between screening and randomisation.</li>\n <li>\n Known cerebral palsy or significant neuro-development delay.</li>\n</ol>\n<p>\n <strong>Renal function Domain</strong></p>\n<ol>\n <li>\n Received paracetamol within 6 hours of screening or between screening and randomisation</li>\n <li>\n Known allergy to paracetamol</li>\n <li>\n Severe malnutrition (middle upper arm circumference MUAC<11.5cm)</li>\n</ol>\n
      • primary_end_points<p>\n Primary endpoints are specific to each domain which include.</p>\n<p>\n Cerebral Malaria Domain</p>\n<ul>\n <li>\n Number of witnessed seizures sufficient to start or change anticonvulsant medication by 72 hours.</li>\n</ul>\n<p>\n Renal Function Domain</p>\n<ul>\n <li>\n Area Under the Curve (AUC) for creatinine over the first 72 hours from randomization based on measurements assayed retrospectively on stored plasma samples taken at randomisation (treated as time 0/baseline) at 24, 48, and 72 hours.</li>\n</ul>\n<p>\n Severe Anaemia Domain:</p>\n<ul>\n <li>\n Change in haemoglobin at 24 hours (adjusted for baseline)</li>\n</ul>\n<p>\n <strong>Secondary endpoints</strong></p>\n<p>\n These will encompass all domains and will include.</p>\n<ul>\n <li>\n Readmissions and mortality to day 28 and day 90.</li>\n <li>\n Grade 3 or 4 adverse events (AEs); and AEs judged related to domain-specific interventions or their comparators during admission as detailed in the domain-specific appendices.</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <strong>Kilifi_Kenya</strong></div>\n<div>\n  </div>\n<div>\n We will draw study clinicians and nurses from the staff currently working in the KEMRI HDU Research Unit, and they will be trained on all aspects of the study protocol and procedures. Additionally, a dedicated study clinician and nurse will closely assist in the operation of the study activities within the trial unit (HDU).</div>\n<p>\n Trial Coordinator: Emmanuel Oguda</p>\n<p>\n The trial will be coordinated and conducted in the KEMRI High Dependency Unit, as well as in other designated pediatric units across various participating sites located in seven hospitals in Africa.</p>\n<p>\n Chief Principal Investigator: Professor Kathryn Maitland will oversee the trial overall.</p>\n<p>\n Local Principal Investigator: Professor Mainga Hamaluba will be responsible for local oversight.</p>\n<p>\n Each site will be overseen and evaluated by specific Country Principal Investigators (PIs) as listed below:</p>\n<p>\n <strong>Democratic Republic of the Congo</strong></p>\n<p>\n Université de Kinshasa, Campus UNIKIN, Lemba, BP 11850, Kinshasa, DRC</p>\n<p>\n Principal Investigator: Prof Marie Onyamboko, MD, DPhil</p>\n<p>\n Co-Investigator: Dr. Catarina Fanello, PhD</p>\n<p>\n <strong>Uganda</strong></p>\n<p>\n Country Principal Investigator: Prof. Peter Olupot Olupot</p>\n<p>\n <strong>Soroti Regional Hospital</strong></p>\n<p>\n Co-Investigator: Dr. Florence Aloroker, MBChB, MMed</p>\n<p>\n Study Site Coordinator: Denis Amorut, BsHSM, RCN</p>\n<p>\n <strong>Dr. Ambrosoli Hospital, Kalongo</strong></p>\n<p>\n Site Investigator: Dr. Okao Maurice, MD, MMED Pediatrics</p>\n<p>\n Study Site Coordinator: Dr. Modester Akite, MD</p>\n<p>\n <strong>Zambia</strong></p>\n<p>\n St. Paul's Mission Hospital, Nchelenge, Luapula Province</p>\n<p>\n Tropical Diseases Research Centre, Ndola Teaching Hospital, P.O Box 71769, Ndola</p>\n<p>\n Principal Investigator: Dr. Mike Chaponda, MSc, MBChB, MSc, DTMH</p>\n<p>\n Co-Investigators: Dr. Sam Miti, MBChB, MMed; Dr. Jonathan Gwasupika, MBChB</p>\n<p>\n <strong>Ghana</strong></p>\n<p>\n Komfo Anokye Teaching Hospital, Bantama High Street, P.O Box 1934, Kumasi</p>\n<p>\n Department of Child Health, Kwame Nkrumah University of Science and Technology, Kumasi</p>\n<p>\n Principal Investigator: Professor Daniel Ansong, MBChB, MSc</p>\n<p>\n Co-Investigators: Prof. Tsiri Agbenyega, PhD; Dr. Justice Sylverken, MBChB</p>\n<p>\n <strong>Mozambique</strong></p>\n<p>\n Hospital Central de Quelimane, Av. Julius Nyerere, Estrada Regional Numero 470, Bairro Namuinho</p>\n<p>\n Manhiça Health Research Centre (CISM), P.O BOX 1929, Manhiça</p>\n<p>\n Co-Lead Investigators: Dr. Rosauro Varo, MD, MSc, PhD, Pediatrician; Dr. Pedro Aide, MD, MSc, PhD</p>\n<p>\n Co-Investigator: Dr. David Torres, MD, MSc, Pediatrician</p>\n<p>\n Co-Investigator: Professor Quique Bassat, MD, MSc, PhD</p>\n
      • other_details_explanation<p>\n The SMAART-MAP trial is being conducted in Kenya, among other African countries, to study hospitalized children with severe malaria, leveraging local hospitals to investigate potential treatments and interventions in a real-world setting where malaria prevalence is high. This facilitates direct evaluation of medical strategies in environments most affected by the disease, aiming to improve patient outcomes and inform future healthcare practices in similar regions.</p>\n
      • other_details_regulatory_notapproved<ol>\n <li>\n Zambia Medicine Regulatory Authority_(ZAMRA)_Zambia</li>\n <li>\n Food and Drugs Authority (FDA) _Ghana</li>\n <li>\n National Medicines Regulatory Authority (Autoridade Nacional Reguladora de Medicamentos, ANARME) _Mozambique</li>\n <li>\n Comité d'Ethique de la Recherche ECOLE DE SANTÉ PUBLIQUE DE KINSHASA</li>\n <li>\n UNIVERSITE DE KINSHASA_Democratic Republic of Congo</li>\n <li>\n National Drug Authority _NDA (Uganda)</li>\n</ol>\n
      • other_details_regulatory_approved<p>\n Not Applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration24 months
      • 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_comparatorStandard of Care
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKilifi County Hospital
      • single_site_physical_addressP.o Box 230 Kilifi
      • single_site_contact_personEmmanuel Oguda
      • single_site_telephone0748588041
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites
      • multi_country_listUganda, Zambia, Ghana, Kenya, Democratic Republic of the Congo and Mozambique
      • data_monitoring_committeeYes
      • total_enrolment_per_siteThe minimum number of participants expected per site is 10, while the maximum is 60.
      • total_participants_worldwide450
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentYes
      • subjects_specifySick children below the age of 12 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf Mainga Hamaluba
      • investigator1_middle_name
      • investigator1_family_nameHamaluba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKilifi Clinical Trials Unit, PO Box 230, Kilifi
      • investigator1_telephone+254 709983946
      • investigator1_emailMHamaluba@kemri-wellcome.org
      • organisations_transferred_Yes
      • number_participantsSince this is a multi-centred trial, the enrollment of study participants will be competitive across the participating sites.
      • notification<p>\n We have uploaded all the relevent document sfor review as per the checklist for submission clinical trials application for approval. </p>\n<h1>\n  </h1>\n
      • approval_date29-08-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-04-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted15-04-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been reviewed under the AVAREF pathway and approved.
      • final_report(null)
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      • final_date(null)
      • modified2025-03-18 14:50:38
      • created2024-04-15 08:48:11
      • total_sites(null)
      • ecitizen_invoice362299
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      • 0(array)
        • id1059
        • application_id1398
        • given_nameProf Kathryn Maitland
        • middle_name
        • family_nameMaitland
        • qualificationProfessor of Paediatric Tropical Infectious Diseases (MBBS PhD)
        • professional_addressBOX 230 KILIFI
        • telephone+254733411022
        • emailkathryn.maitland@gmail.com
        • created2024-04-15 09:41:34
        • modified2024-08-07 16:24:21
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        • id1695
        • application_id1398
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        • created2024-04-15 09:41:34
        • modified2024-08-07 16:24:21
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id740
        • application_id1398
        • sponsorImperial College London
        • sponsor_typeOthers
        • contact_personJoint Research Compliance Office
        • addressImperial College London Room 215, Level 2, Medical School Building Norfolk Place London, W2 1PG
        • telephone_numberTel: 020 7594 1872
        • fax_number
        • cell_numberTel: 020 7594 1872
        • email_addressr.nicholson@imperial.ac.uk
        • created2024-04-15 09:41:34
        • modified2024-08-07 16:24:21
  • 1(array)
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      • id669
      • user_id413
      • trial_status_id6
      • abstract_of_study<p>\n Safe and Effective Contraception is a universal right for all men and women. Many women of reproductive age are unable to  use the current contraception methods available to them and rely on their male partners to protect them from unplanned pregnancy.  A majority of men surveyed internationally reported interest and willingness to use contraceptive methods; unfortunately no safe, highly effective reversible method is available to men interested in sharing the responsibility of family planning.The primary objective  of the CCN017 male contraception study is to determine the contraception efficacy, safety and acceptablily for a couple provided by daily application of the male partner of a gel containing Nesteron 8mg and Testesterone 62mg (NES 8/T 62) for a period of 52 weeks</p>\n<p>\n <strong>Methodology</strong></p>\n<p>\n This is a prospective, phase IIb, open label, single arm, multicenter study. The study consists of a screening phase lasting 4 to 8 weeks, a suppression phase estimated to last up to 20 weeks, a 52- week maintenance/efficacy phase, and a 24-week (estimated) recovery phase.  The study population will comprise healthy men ages 18 – 50 years, involved in a stable, monogamous, relationship  with an 18 – 34 year-old female partner (at the time of enrolment) with regular cycles per patient report from her previous non-hormonal contraceptive gynecology history. Across all sites, the study will enrol 420 couples into the suppression phase. The Couples Counselling Clinic will aim to enrol 60 couples into the suppression phase.Questionnaires will be administered during the study in the Couples Counselling Clinic, with the exception of the 7-Day Validated Psychosexual Daily Questionnaire that will be completed by the participant at home.  Blood samples for laboratory analyses will be collected at visits throughout each phase of the study for processing at both the central laboratory and at Pathology Lancet Kenya.</p>\n<p>\n <strong>Informed Consent</strong></p>\n<p>\n The principles of informed consent will be implemented according to the Declaration of Helsinki in its currently acknowledged version, ICH Consolidated Good Clinical Practice, KNH/UON Ethics Review committee.   Participants male and female, that agree to voluntarily participate in the study must sign the informed consent form (ICF) prior to study-specific procedures.</p>\n
      • study_title<h1>\n <em><strong><span style=\"font-size:16px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Clinical Evaluation of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception.</span></span></strong></em></h1>\n<h1>\n  </h1>\n
      • laymans_summary<p>\n Forty percent (40%) of preg- nancies globally are un- planned. Many women are unable to use hormonal con- traceptives due to the side effects.  International surveys show that men are interested and willing to use male contracep- tion to support their female partners</p>\n<div>\n Current contraception options available for men are con- doms and vasectomies.</div>\n<div>\n More options are needed to support men in meeting their contraceptive needs.</div>\n<div>\n  </div>\n<div>\n OUR STUDY</div>\n<div>\n We are conducting and international, multicenter clinical trial study for male birth control. Our Mission is to develop safe and effective contraception for men.</div>\n<div>\n The primary objective of our study is to determine contracep- tive efficacy for a couple provided by daily application by the male partner of a gel containing testosterone (T) and Nestorone (NES) .</div>\n<div>\n The couples will be in the study for 2 years to test the safety and efficacy of the study gel</div>\n<div>\n Study Goal:</div>\n<div>\n To develop new forms of birth control for men that are:</div>\n<div>\n • Safe</div>\n<div>\n • Reversible</div>\n<div>\n • May be self-delivered</div>\n<div>\n • Affordable</div>\n<div>\n • Have health benefits for men</div>\n<div>\n  </div>\n<div>\n Study Gel</div>\n<div>\n General requirements for entering the study:</div>\n<div>\n Be heterosexual couple: Male, 18-50 years and fe- male, age 18-34 years.</div>\n<div>\n Sexually active, in a stable, monogamous relationship for at least 1 year and plan to be in the relationship for duration of the study duration.</div>\n<div>\n Willingness to accept a low but unknown risk of con- ceiving a pregnancy for the duration of the study.</div>\n<div>\n Live in Nairobi and its environs</div>\n<div>\n Female Partner:</div>\n<div>\n Have regular menstrual cycles of 21-35 days in duration, when not using hormonal contraception.</div>\n<div>\n Intend to remain in a monogamous relationship with male study partner during study.</div>\n<div>\n Not breastfeeding or pregnant.</div>\n<div>\n  </div>\n<div>\n Male Partner:</div>\n<div>\n Be in good health and of normal height and weight. No current disease ( eg diabetes, HIV, hepatitis).</div>\n<div>\n Able to fast for at least 8 hours during the study prior to blood draws and abstain from sex for 2-7 days prior to scheduled clinic visit.</div>\n<div>\n Able to provide semen sample by masturbation during clinic visits</div>\n<div>\n No history of depression or other serious mental health disorder, including use of an antidepressant</div>\n<div>\n No current or previous excessive alcohol use, illicit drug, including marijuana, or anabolic steroid abuse.</div>\n<div>\n A combination Gel with Nestorone® (NES) and Testos- terone (T) applied daily.</div>\n<div>\n The 5ml of the gel is applied on the upper arms and shoulders daily.</div>\n
      • short_titleCCNO17 Male contraception study.
      • protocol_noECCT/18/07/01
      • version_no3.0
      • date_of_protocol04-04-2018
      • study_drugNestorone (NES) and Testosterone (T) Combination Gel
      • disease_conditionContraception
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameNES 8 mg/day + T 62 mg/day (NES-8/T-62) gel
      • product_type_medical_device_namemetered pump canisters
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressseshiwanin@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDr Sheila Juliet Eshiwani
      • declaration_date125-06-2018
      • declaration_principal_investigatorDr John Kinuthia
      • declaration_date225-06-2018
      • placebo_presentNo
      • study_objectives<p>\n The overall goal of this study is to develop a hormonal contraceptive method for men that is effective, safe, reversible, self-delivered, user-controlled and affordable. The objective of this study is to determine whether application of a combined gel containing an androgen, Testosterone (T), and a progestin, Nestorone®, applied transdermally once per day will suppress spermatogenesis and be effective as a contraceptive method in healthy couples who wish to avoid pregnancy and are willing to use the method as their primary method of birth control.</p>\n<div>\n Primary objective</div>\n<div>\n The primary objective of the study is to determine the contraceptive efficacy for a couple provided by continued daily application by the male partner of a gel containing testosterone (T) and Nestorone (NES) for a period of 52 weeks (about 12 months).</div>\n<div>\n  </div>\n<div>\n  Secondary objectives</div>\n<div>\n The secondary objectives of the study are to assess safety and acceptability of the NES 8 mg/day + T 62 mg/day (NES-8/T-62) gel.</div>\n<div>\n  </div>\n
      • principal_inclusion_criteria<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" height=\"345\" width=\"568\">\n <tbody>\n <tr>\n <td style=\"width:564px;height:350px;\">\n <p style=\"margin-left:5.15pt;\">\n <strong>Male Partner – Inclusion Criteria</strong>: Men who meet all the following criteria will be eligible for enrollment in the trial:</p>\n <ol>\n <li>\n Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;</li>\n <li>\n 18 to 50 years of age, at the enrollment visit;</li>\n <li>\n BMI < 33 kg/m2;</li>\n <li>\n No history of androgen use in the six months prior to the first screening visit;</li>\n <li>\n Agreement to use an effective method of contraception with his female partner during the suppression and recovery phases and then only use the experimental method during the efficacy phase of the study;</li>\n <li>\n In the opinion of the investigator, the male participant is willing and able to comply with the protocol;</li>\n <li>\n The participant is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study’s provisions and has duly signed the informed consent form</li>\n <li>\n <p>\n Sexually active with a female partner (as specified below) with whom he has been in a stable, mutually monogamous relationship for at least 1 year prior to screening and with whom he intends to remain in a relationship for the duration of the study;</p>\n </li>\n <li value=\"9\">\n Normal reproductive state as demonstrated by:\n <ul>\n <li>\n Sperm concentration ≥15 million/mL in two semen samples and with no gross abnormalities of sperm motility and morphology on at least one semen sample assessment;</li>\n <li>\n Screening Testosterone within the study site’s local lab normal reference range for adult men;</li>\n </ul>\n </li>\n <li value=\"10\">\n Willingness to accept a low but unknown risk of conceiving a pregnancy for the duration of the trial.</li>\n </ol>\n <p style=\"margin-left:5.15pt;\">\n <strong>Female Partner – Inclusion Criteria: </strong>Women who meet all the following criteria will be eligible for enrollment in the trial:</p>\n <ol>\n <li>\n Good general health with no chronic medical conditions that result in periodic exacerbations which require significant medical care or are known to affect fertility;</li>\n <li>\n Aged between 18 and 34 years, inclusive, at the enrollment visit;</li>\n <li>\n Have regular menstrual cycles of 21-35 days in duration, per patient report, when not using hormonal contraception. If hormonal contraception has been used, the following applies:\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n If recently used intramuscular Depo-Provera must have had last injection at least 3 months prior enrollment;</li>\n <li>\n If using an IUD or an implant, she is planning to have this removed for purposes unrelated to enrollment in the study prior to entering the efficacy phase;</li>\n <li>\n Completion of her last pack of oral contraceptives or completion of effectiveness period for a monthly injection, patch or ring if any has been used prior to entering the efficacy phase;</li>\n </ol>\n </li>\n <li>\n Have intact uterus and both ovaries (waivers for women who have one ovary may be submitted so that the circumstances related to prior ovarian removal can be assessed);</li>\n <li>\n The participant is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study’s provisions and has duly signed the informed consent form (ICF);</li>\n <li>\n Consistent use of effective contraception during the preceding cycle prior to enrolling;</li>\n <li>\n No known infertility;</li>\n <li>\n Intends to remain in a monogamous relationship with male study partner (as specified above). (Note: this study will not provide her contraception for intercourse with any other male partners);</li>\n <li>\n Be at risk for pregnancy with participating male partner (heterosexual vaginal intercourse at least once per cycle and not sterilized);</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" height=\"626\" width=\"566\">\n <tbody>\n <tr>\n <td style=\"width:145px;height:877px;\">\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:564px;height:877px;\">\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p style=\"margin-left:5.15pt;\">\n <strong>Male Partner  </strong>Men who meet any of the following criteria are not eligible for enrollment in the trial:</p>\n<p style=\"margin-left:59.15pt;\">\n 1.            Men participating in another clinical trial involving an investigational drug within the last 30 days (or within five half-lives of the investigational drug, whichever is longer) prior to the first screening visit.</p>\n<p style=\"margin-left:59.15pt;\">\n 2.            Men not living in the catchment’s area of the study site or within a reasonable distance from the site.</p>\n<p style=\"margin-left:59.15pt;\">\n 3.            Clinically significant abnormal findings at screening per the Investigator’s medical judgment.</p>\n<p style=\"margin-left:59.15pt;\">\n 4.            Elevated PSA levels ≥ 4 ng/mL.</p>\n<p style=\"margin-left:59.15pt;\">\n 5.            Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction.</p>\n<p style=\"margin-left:59.15pt;\">\n 6.            Use of androgens or other anabolic steroids that may suppress gonadotropins within 6 months prior to the first screening visit.</p>\n<p style=\"margin-left:59.15pt;\">\n 7.            Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 3 measurements will be used to determine eligibility).</p>\n<p style=\"margin-left:59.15pt;\">\n 8.            History of hypertension, including hypertension controlled with treatment.</p>\n<p style=\"margin-left:59.15pt;\">\n 9.            Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.</p>\n<p style=\"margin-left:59.15pt;\">\n 10.          Known hypersensitivity to progestins or testosterone or any excipient of the investigational product.</p>\n<p style=\"margin-left:59.15pt;\">\n 11.          History of prostate, testicular or breast carcinoma.</p>\n<p style=\"margin-left:59.15pt;\">\n 12.          Significant prostatic symptoms (IPSS > 15).</p>\n<p style=\"margin-left:59.15pt;\">\n 13.          Known history of reproductive dysfunction including vasectomy or infertility.</p>\n<p style=\"margin-left:59.15pt;\">\n 14.          Known history of significant cardiac, renal, hepatic or prostatic disease.</p>\n<p style=\"margin-left:59.15pt;\">\n 15.          History of thromboembolic disease.</p>\n<p style=\"margin-left:59.15pt;\">\n 16.          A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV, or morbid obesity.</p>\n<p style=\"margin-left:59.15pt;\">\n 17.          Current active or ongoing Hepatitis infection.</p>\n<p style=\"margin-left:59.15pt;\">\n 18.          History of untreated sleep apnea.</p>\n<p style=\"margin-left:59.15pt;\">\n 19.          Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.</p>\n<p style=\"margin-left:59.15pt;\">\n 20.          Any known active or chronic dermatitis or other severe skin disorder.</p>\n<p style=\"margin-left:59.15pt;\">\n 21.          Any skin condition that might interfere with absorption of gel.</p>\n<p>\n Couples           desiring            fertility within   the       study   participation     period (approximately 104 weeks from screening to end of recovery).</p>\n<p style=\"margin-left:59.15pt;\">\n 23.          PHQ9 score ≥15 or history of severe depression or other serious mental health disorder, including ongoing use of an anti-depressant.</p>\n<p style=\"margin-left:59.15pt;\">\n 24.          Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) of a single application.</p>\n<p style=\"margin-left:59.15pt;\">\n 25.          Use of sex steroids or medications which might interfere with steroid metabolism (i.e. ketoconazole, finasteride, oral corticosteroids, dutasteride and statins).</p>\n<p style=\"margin-left:59.15pt;\">\n 26.          Use of anticoagulants.</p>\n<p style=\"margin-left:59.15pt;\">\n 27.          Use of medications that will interfere or interact with Nestorone or Testosterone (see <strong>Appendix 2</strong>).</p>\n<p style=\"margin-left:59.15pt;\">\n 28.          Use of oily cosmetic skin gels/products that would prevent absorption of steroids.</p>\n<p style=\"margin-left:59.15pt;\">\n 29.          Previous participation in this clinical trial.</p>\n<p style=\"margin-left:59.15pt;\">\n 30.          Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.</p>\n<p>\n  </p>\n<p style=\"margin-left:5.15pt;\">\n <strong>Female Partner – Exclusion Criteria:</strong></p>\n<p style=\"margin-left:59.15pt;\">\n 1.            Desire to become pregnant during the study.</p>\n<p style=\"margin-left:59.15pt;\">\n 2.            Breastfeeding.</p>\n<p style=\"margin-left:59.15pt;\">\n 3.            Known or suspected current alcoholism or drug abuse.</p>\n<p style=\"margin-left:59.15pt;\">\n 4.            Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.</p>\n<p style=\"margin-left:59.15pt;\">\n 5.            Currently pregnant.</p>\n<p style=\"margin-left:59.15pt;\">\n 6.            Known hypersensitivity to progestins or testosterone.</p>\n<p style=\"margin-left:59.15pt;\">\n 7.            History associated with impaired fertility (e.g. history of pelvic inflammatory disease, unilateral salpingectomy or endometriosis).</p>\n<p style=\"margin-left:59.15pt;\">\n 8.            Previous participation in this clinical trial.</p>\n<p>\n Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.</p>\n
      • primary_end_points<p>\n Twelve-month (365 days) cumulative contraceptive efficacy in couples, during the efficacy portion of the study, in which the male partner uses the product daily to suppress sperm production and the couple uses the method as their sole contraceptive method is the primary endpoint for this study. Kaplan-Meier methods will be used to estimate the twelve-month cumulative pregnancy probability (and 95% CI) in the typical use population </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_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p class=\"MsoNormal\" style=\"margin-top:0cm;margin-right:.1pt;margin-bottom:9.55pt;\nmargin-left:0cm\">\n <b style=\"mso-bidi-font-weight:normal\"><span lang=\"EN-GB\">Study Site</span></b></p>\n<p class=\"MsoNormalCxSpMiddle\" style=\"margin-right:.1pt;mso-add-space:auto;\nline-height:150%\">\n <span lang=\"EN-GB\" style=\"color:black\">The</span><span lang=\"EN-GB\"> study will be located in our research clinic at Kenyatta National Hospital, located in the Couples Counselling Center. The Couple Counselling Center was founded in 2004 as a research study site by the Kenyatta National Hospital in collaboration with University of Washington. </span></p>\n<p class=\"MsoNormalCxSpMiddle\" style=\"margin-right:.1pt;mso-add-space:auto;\nline-height:150%;tab-stops:163.5pt\">\n <span lang=\"EN-GB\"><span style=\"mso-tab-count:\n1\">                                                       </span></span></p>\n<p class=\"MsoNormalCxSpLast\" style=\"margin-right:.1pt;mso-add-space:auto;\nline-height:150%\">\n <span lang=\"EN-GB\">The Couple Counselling Center has the following facilities to support conduct of research:</span></p>\n<p class=\"MsoListParagraphCxSpFirst\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">1.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Two reception areas</span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">2.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Six consultation/data collection rooms</span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">3.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Data management room</span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">4.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Pharmacy </span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span lang=\"EN-GB\"><span style=\"mso-list:Ignore\">5.<span new=\"\" style=\"font:7.0pt \" times=\"\">     </span></span></span><span lang=\"EN-GB\">Procedure room that will be used for semen collection.<span style=\"mso-spacerun:yes\">  </span></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"text-indent: -18pt; line-height: 150%; margin-left: 54pt;\">\n The study will employ the following staff;</p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">Site staff, names , qualifications and Experience</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">1 study coordinator</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">2 Clinical officer</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">1 nurse</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">2 Recruitment and retention Officers</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">1 data clerk</span></span></strong></span></p>\n<p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-left:54.0pt;mso-add-space:\nauto;text-indent:-18.0pt;line-height:150%;mso-list:l0 level1 lfo1\">\n <span style=\"color:#ff0000;\"><strong><span lang=\"EN-GB\"><span style=\"background-color:#ffff00;\">I Study administrator</span></span></strong></span></p>\n<p class=\"MsoNormalCxSpFirst\" style=\"margin-right:.1pt;mso-add-space:auto;\nline-height:150%\">\n <span lang=\"EN-GB\">Several studies involving couples have been conducted at the Couples Counselling Centre including <span style=\"mso-spacerun:yes\"> </span><span style=\"mso-spacerun:yes\"> </span>women’s reproductive lifecourse events and HIV transmission potential: The clinic is currently a Prevention and Care and treatment center for HIV affected couples and is also a site for the Impact of Periconceptual Vaginal Microbiota on Women’s Risk of Preterm Birth Study that is currently ongoing.  </span></p>\n<p>\n <strong>Laboratory procedures </strong></p>\n<p>\n Blood samples for laboratory analyses will be collected at visits throughout each phase of the study for processing at both the central laboratory and at Pathology Lancet Kenya. (Please see page 38-41 of the main study protocol ).</p>\n<p>\n <span lang=\"EN-GB\" style=\"color:black\">Pathologists Lancet Kenya Limited is part of the Lancet Group of Laboratories, originally founded in South Africa. <span style=\"mso-spacerun:yes\"> </span>The Main Laoratory in Nairobi is located at 5th Avenue Office Suites just opposite traffic headquarters.<span style=\"mso-spacerun:yes\">  </span><span style=\"mso-spacerun:yes\"> </span>T</span><span lang=\"EN-GB\">he laboratory is about 1.3kilometres from the Couple Counselling Center. </span></p>\n<p class=\"MsoNormalCxSpMiddle\" style=\"line-height:150%\">\n <span lang=\"EN-GB\" style=\"color:black\">The Pathologists Lancet Kenya will perform laboratory-screening tests for the determination of study eligibility of the participants. This include semen analysis, complete blood counts, clinical chemistry panel, full lipid panel and prostatic specific antigen.<span style=\"mso-spacerun:yes\">  </span></span></p>\n<p class=\"MsoNormalCxSpMiddle\" style=\"line-height:150%\">\n <span lang=\"EN-GB\" style=\"color:black\">Pathologists Lancet Kenya andrology department received SANAS accreditation in 2017. The department has two trained technologists who handle the semen samples. The laboratory runs about 100 semen lysis samples every month. 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      • other_details_explanation
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Kenyatta  National Hospital/ University of Nairobi Ethical review Comittee.  KNH/UoN ERC</p>\n<p>\n University of Washington Institutional Review Board (IRB)</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3years
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNo comparator
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaCouples counselling Center
      • single_site_physical_addressKenyatta National Hospital
      • single_site_contact_personDr John Kinuthia
      • single_site_telephone0722799052
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites
      • multi_country_list1)United States of America\nLos angeles biomedical Research Institute at Harbor- UCLA Medical\nUniversity of Washington\nUniversity of Kansas\n2)Chile, Chilean Institute of Reproductive Medicine, Santiago.\n3) Sweden Karolinsk Institute, Stockholm.\n4) United Kingdom, University of Manchester.\nUniversity of Edinburgh \n5)Italy, University of Bologna\n6) Kenya, Kenyatta National Hospital.\n
      • data_monitoring_committeeYes
      • total_enrolment_per_site40-70
      • total_participants_worldwide420
      • 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_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_nameDr Sheila
      • investigator1_middle_name
      • investigator1_family_nameEshiwani
      • investigator1_qualificationMBChB
      • investigator1_professional_addressPO BOX 30681 00100
      • investigator1_telephone0721236111
      • investigator1_emailseshiwanin@gmail.com
      • organisations_transferred_Yes
      • number_participants40-70
      • notification
      • approval_date19-11-2018
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-04-11 10:18:49
      • created2018-05-02 10:17:50
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id420
        • application_id669
        • given_nameDr John
        • middle_name
        • family_name Kinuthia
        • qualificationMBChB, MMed Obs/gyn MPH
        • professional_addressPO Box 20273-00202,Kenyatta National Hospital
        • telephone0722799052
        • emailkinuthia@uw.edu
        • created2018-05-02 10:53:03
        • modified2020-08-18 14:32:20
    • SiteDetail(array)
      • 0(array)
        • id537
        • application_id669
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-05-02 10:53:03
        • modified2020-08-18 14:32:20
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id335
        • application_id669
        • sponsorNational Institute of Health NIH (Eunice Shriver National institute of childhealth and human development NICHD
        • sponsor_typeResearch Institution
        • contact_personDr Jill Long
        • address6710B ROCKLEDGE DRIVE
        • telephone_number+13014961662
        • fax_number
        • cell_number+13014961662
        • email_addressjill.long@nih.gov
        • created2018-05-02 10:53:03
        • modified2020-08-18 14:32:20
      • 1(array)
        • id342
        • application_id669
        • sponsorPopulation Council.
        • sponsor_typeResearch Institution
        • contact_personDr Regine Sitruk-Ware
        • address1230 york avenue, New york,NY 10065 USA
        • telephone_number+13014961662
        • fax_number
        • cell_number+13014961662
        • email_addressfsitrukware@popcouncil.org
        • created2018-05-25 11:37:33
        • modified2020-08-18 14:32:20
  • 2(array)
    • Application(array)
      • id556
      • user_id613
      • trial_status_id7
      • abstract_of_study<div>\n <p align=\"center\" style=\"margin-left: 196.1pt;\">\n <strong>SCHEMA IMPAACT P1093</strong></p>\n <p>\n  </p>\n <p align=\"center\" style=\"margin-left: 9.1pt;\">\n <strong>P</strong><strong>hase I/II Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in</strong></p>\n <p align=\"center\" style=\"margin-left: 120.2pt;\">\n <strong>H</strong><strong>IV-1 Infected Infants, Children and Adolescents</strong></p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>DE</strong><strong>SIGN:                                </strong>Phase I/II, multi-center, open-label, non-comparative intensive PK and safety study</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>SAMPLE SIZE:                      </strong>Approximately 160 HIV-1 infected infants, children and adolescents to provide a minimum of 120 evaluable* subjects:</p>\n <p style=\"margin-left: 185.05pt;\">\n Stage I – a minimum of 10 subjects, per cohort</p>\n <p style=\"margin-left: 185.05pt;\">\n Stage II – a minimum of 60 evaluable subjects across all cohorts</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n *Evaluable is defined as having been treated exclusively on the dose determined to be optimal for a given age cohort and having either completed 24 (or 48) weeks of exposure to the study drug or having been classified as a safety failure, due to a study drug related adverse event occurring during the first 24 (or 48) weeks of treatment.</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>POPULATION:                      </strong>HIV infected infants, children and adolescents aged ≥ 4 weeks to < 18 years of age.</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>STRATIFICATION:              </strong>All subjects enrolled into the study will be stratified at screening into one of nine age specific cohorts as follows:</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohort I:         </strong>Adolescents ≥ 12 to <18 years of age</p>\n <p align=\"center\" style=\"margin-left: 219.2pt;\">\n (Film-coated Tablets)</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohort IIA:    </strong>Children ≥ 6 to <12 years of age</p>\n <p align=\"center\" style=\"margin-left: 219.2pt;\">\n (Film-coated Tablets)</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohort IIB:     </strong>Children ≥ 6 to <12 years of age</p>\n <p style=\"margin-left: 221.05pt;\">\n (Granules for suspension)</p>\n <p style=\"margin-left: 221.05pt;\">\n Note: Dispersible tablets may also be evaluated in this cohort if requested by regulatory authorities.</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohorts III:    </strong>Children ≥ 2 to < 6 years of age</p>\n <p style=\"margin-left: 221.05pt;\">\n (Granules for suspension)</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohort III-DT</strong>: Children ≥ 2 to < 6 years of age</p>\n <p align=\"center\" style=\"margin-left: 219.2pt;\">\n (Dispersible Tablets)</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohort IV</strong>:      Children ≥ 6 months to < 2 years of age</p>\n <p style=\"margin-left: 221.05pt;\">\n (Granules for suspension)</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohort IV-DT: </strong>Children ≥ 6 months to < 2 years of age</p>\n <p align=\"center\" style=\"margin-left: 219.2pt;\">\n (Dispersible Tablets)</p>\n</div>\n<p>\n  </p>\n<div>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohort V</strong>:        Infants <u>></u> 4 weeks to < 6 months of age</p>\n <p style=\"margin-left: 221.05pt;\">\n (Granules for suspension)</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>C</strong><strong>ohort V-DT: </strong>Infants <u>></u> 4 weeks to < 6 months</p>\n <p align=\"center\" style=\"margin-left: 219.2pt;\">\n (Dispersible Tablets)</p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>REG</strong><strong>IMEN:                            </strong>Three different dolutegravir (DTG) formulations will be evaluated as follows: film-coated tablets; a granule formulation for suspension; and dispersible tablets. The final dose for each formulation and each age cohort will be selected based on real-time PK evaluations and safety to achieve exposure similar to that observed in adults treated with 50 mg QD.</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n See Sections 5.0-5.4 for details on DTG drug regimens, formulations, drug supply and handling.</p>\n <p>\n  </p>\n <p style=\"margin-left: 5pt;\">\n <strong>TREAT</strong><strong>MENT DURATION:  </strong>Stages I and II: 48 Weeks</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n Long Term Safety Follow-up: All subjects who successfully complete 48 weeks of DTG treatment will continue to receive DTG for a minimum of three years as part of long term safety follow-up. (See Section 6.3 and Appendix IE for details).</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n <strong>H</strong><strong>Y</strong><strong>POTHESIS:                      </strong>DTG will be generally well tolerated and demonstrate an acceptable safety profile, adequate PK and antiviral activity when used concurrently with an optimized background therapy (OBT) in HIV-1 infected infants, children and adolescents.</p>\n <p>\n  </p>\n <p style=\"margin-left: 5pt;\">\n <strong>O</strong><strong>B</strong><strong>JECTIVES:</strong></p>\n <p>\n  </p>\n <p style=\"margin-left: 5pt;\">\n <u>PRIMARY OBJECTIVES</u></p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 1.   To select a dose for each formulation of DTG for chronic dosing in infants, children and adolescents that achieves similar exposure to the DTG 50 mg once daily dose in adults.</p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 2.   To determine the safety and tolerability of DTG in HIV-1 infected infants, children and adolescents at 24 and 48 weeks.</p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 3.   To evaluate the steady-state pharmacokinetics of DTG in combination with other antiretrovirals (OBT) in treatment-experienced and/or treatment-naïve HIV-1 infected infants, children and adolescents and to determine the dose of DTG that achieves a targeted AUC24 (primary PK endpoint) and C24h (secondary PK endpoint) in this population.</p>\n <p>\n  </p>\n <p style=\"margin-left: 5pt;\">\n <u>SECONDARY OBJECTIVES</u></p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 1.   To evaluate the antiviral activity of DTG in combination with an OBT by measuring virologic response in infants, children and adolescents at 24 and 48 weeks.</p>\n <p>\n  </p>\n <p style=\"margin-left: 23pt;\">\n 2.   To evaluate the effect on immunologic response from baseline to 24 and 48 weeks.</p>\n</div>\n<p>\n  </p>\n<p style=\"margin-left: 23pt;\">\n 3.   To assess changes in HIV-1 genotype and phenotype to DTG and other components of the OBT</p>\n<p style=\"margin-left: 41pt;\">\n in subjects experiencing virologic failure.</p>\n<p>\n  </p>\n<p style=\"margin-left: 23pt;\">\n 4.   To determine DTG exposure, its variability and clinical covariates that impact DTG disposition</p>\n<p style=\"margin-left: 41pt;\">\n (e.g. age, weight) using intensive and sparse sampling and population pharmacokinetic analysis.</p>\n<p>\n  </p>\n<p style=\"margin-left: 41pt;\">\n 5.   To determine the extended long term (≥48 weeks) safety and tolerability of DTG in HIV-1 infected infants, children and adolescents.</p>\n<p>\n  </p>\n<p style=\"margin-left: 23pt;\">\n 6.   To explore the relationship between DTG exposure and the antiviral activity.</p>\n
      • study_title<p align=\"center\" style=\"margin-left: 4.55pt;\">\n <strong>P</strong><strong>h</strong><strong>ase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents</strong><strong>P</strong><strong>h</strong><strong>ase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents</strong></p>\n
      • laymans_summary<p>\n This is a study enrolling infants, children and adolescents aged >4weeks to <18 years to asses the safety tolerability and antiviral activity of DTG. Participants are followed up for a total duration of 4 years.</p>\n
      • short_titleIMPAACT P1093
      • protocol_noECCT/16/11/02
      • version_noVersion 4.0
      • date_of_protocol13-04-2016
      • study_drugDolutegravir (DTG)
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTivicay
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjoel.chebon@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training0
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJoel Chebon
      • declaration_date119-09-2016
      • declaration_principal_investigatorLucy C. Koech
      • declaration_date219-09-2016
      • placebo_presentNo
      • study_objectives<div>\n <p style=\"margin-left: 5pt;\">\n <u>PRIMARY OBJECTIVES</u></p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 1.   To select a dose for each formulation of DTG for chronic dosing in infants, children and adolescents that achieves similar exposure to the DTG 50 mg once daily dose in adults.</p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 2.   To determine the safety and tolerability of DTG in HIV-1 infected infants, children and adolescents at 24 and 48 weeks.</p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 3.   To evaluate the steady-state pharmacokinetics of DTG in combination with other antiretrovirals (OBT) in treatment-experienced and/or treatment-naïve HIV-1 infected infants, children and adolescents and to determine the dose of DTG that achieves a targeted AUC24 (primary PK endpoint) and C24h (secondary PK endpoint) in this population.</p>\n <p>\n  </p>\n <p style=\"margin-left: 5pt;\">\n <u>SECONDARY OBJECTIVES</u></p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 1.   To evaluate the antiviral activity of DTG in combination with an OBT by measuring virologic response in infants, children and adolescents at 24 and 48 weeks.</p>\n <p>\n  </p>\n <p style=\"margin-left: 23pt;\">\n 2.   To evaluate the effect on immunologic response from baseline to 24 and 48 weeks.</p>\n</div>\n<p>\n  </p>\n<p style=\"margin-left: 23pt;\">\n 3.   To assess changes in HIV-1 genotype and phenotype to DTG and other components of the OBT</p>\n<p style=\"margin-left: 41pt;\">\n in subjects experiencing virologic failure.</p>\n<p>\n  </p>\n<p style=\"margin-left: 23pt;\">\n 4.   To determine DTG exposure, its variability and clinical covariates that impact DTG disposition</p>\n<p style=\"margin-left: 41pt;\">\n (e.g. age, weight) using intensive and sparse sampling and population pharmacokinetic analysis.</p>\n<p>\n  </p>\n<p style=\"margin-left: 41pt;\">\n 5.   To determine the extended long term (≥48 weeks) safety and tolerability of DTG in HIV-1 infected infants, children and adolescents.</p>\n<p>\n  </p>\n<p style=\"margin-left: 23pt;\">\n 6.   To explore the relationship between DTG exposure and the antiviral activity.</p>\n
      • principal_inclusion_criteria<div>\n <p style=\"margin-left: 5pt;\">\n <strong>4.1       Inclusion Criteria</strong></p>\n <p>\n  </p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 4.1.1    Age: ≥ 4 weeks to <strong><</strong>18 years at study entry</p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 4.1.2    Confirmed HIV-1 infection</p>\n <p>\n  </p>\n <p style=\"margin-left: 95pt;\">\n ·    Documentation of HIV-1 infection defined as positive results from <u>two</u> samples collected at <u>different</u> time points. All samples tested must be whole blood, serum or plasma. All test methods should be FDA-approved if available. If FDA-approved methods are not available, test methods should be verified according to GCLP and approved by the IMPAACT central laboratory.</p>\n <p style=\"margin-left: 113pt;\">\n o  Sample #1 may be tested by non-study public or PEPFAR programs.</p>\n <p style=\"margin-left: 131pt;\">\n However, both the result and the assay date must be recorded in the subject’s</p>\n <p style=\"margin-left: 131pt;\">\n chart. Source documentation (patient’s medical record/chart, in-country</p>\n <p style=\"margin-left: 131pt;\">\n Ministry of Health registers, laboratory results, etc.) must be available if requested.</p>\n <p style=\"margin-left: 131pt;\">\n o  Sample #2 must be performed in a CAP/CLIA-approved laboratory (for US sites) or in a laboratory that operate according to GCLP guidelines and participates’ in appropriate external quality assurance program (for non-US sites).</p>\n</div>\n<p>\n  </p>\n<div>\n <p>\n  </p>\n <p style=\"margin-left: 74pt;\">\n <u>4.1.2.1 Acceptable tests when subjects are ≤ 18 months of age</u></p>\n <p>\n  </p>\n <p style=\"margin-left: 74pt;\">\n Sample #1 and Sample #2 may be tested using any of the following:</p>\n <p>\n  </p>\n <p style=\"margin-left: 74pt;\">\n ·    One HIV DNA PCR</p>\n <p style=\"margin-left: 74pt;\">\n ·    One quantitative HIV RNA  PCR (above the limit of detection of the assay)</p>\n <p style=\"margin-left: 74pt;\">\n ·    One qualitative HIV RNA PCR</p>\n <p style=\"margin-left: 74pt;\">\n ·    One total HIV nucleic acid</p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n Note: Subjects ≤ 18 months of age can be enrolled on the basis of one positive test result (from Sample #1) if the results from Sample #2 are pending. The HIV RNA test required at screening per the Schedule of Evaluations may serve as Sample #2 and may be</p>\n <p style=\"margin-left: 77pt;\">\n pending at the time of enrollment. However, any subject in whom infection is not confirmed by the results of Sample #2 should discontinue study drug, per Section 6.6 and be followed per Appendix IF.</p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n <u>4.1.2.2 Acceptable tests when subjects are > 18 months of age</u></p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n Sample #1 may be tested using any of the following:</p>\n <p>\n  </p>\n <p style=\"margin-left: 95pt;\">\n ·    Two rapid antibody tests from different manufacturers or based on different principles and epitopes</p>\n <p style=\"margin-left: 77pt;\">\n ·    One EIA OR Western Blot OR immunofluorescence OR chemiluminescence</p>\n <p style=\"margin-left: 77pt;\">\n ·    One HIV DNA PCR</p>\n <p style=\"margin-left: 77pt;\">\n ·     One quantitative HIV RNA PCR (above the limit of detection of the assay)</p>\n <p style=\"margin-left: 77pt;\">\n ·    One qualitative HIV RNA PCR</p>\n <p style=\"margin-left: 77pt;\">\n ·    One HIV culture (prior to August 2009)</p>\n <p style=\"margin-left: 77pt;\">\n ·    One total HIV nucleic acid</p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n Sample #2 may be tested using any of the following:</p>\n <p>\n  </p>\n <p style=\"margin-left: 95pt;\">\n ·    Rapid antibody test. If this option is used in combination with the two tests for Sample #1, at least one of the three rapid antibody tests for Sample #1 must be FDA approved and the third rapid test must be from a third manufacturer or based on a third principle or epitope.</p>\n <p style=\"margin-left: 77pt;\">\n ·    One EIA  OR  Western Blot OR immunofluorescence OR chemiluminescence</p>\n <p style=\"margin-left: 77pt;\">\n ·    One HIV DNA PCR</p>\n <p style=\"margin-left: 77pt;\">\n ·    One quantitative HIV RNA PCR (above the limit of detection of the assay)</p>\n <p style=\"margin-left: 77pt;\">\n ·    One qualitative HIV RNA PCR</p>\n <p style=\"margin-left: 77pt;\">\n ·    One HIV culture (prior to August 2009)</p>\n <p style=\"margin-left: 77pt;\">\n ·    One total HIV nucleic acid</p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n  </p>\n <p style=\"margin-left: 41pt;\">\n 4.1.3     Subjects must belong to one of the ARV exposure groups below:</p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n 4.1.3.1  ARV-treatment experienced (not including receipt of ARVs as prophylaxis or</p>\n <p align=\"center\" style=\"margin-left: 111.2pt;\">\n PMTCT)</p>\n <p>\n  </p>\n <p style=\"margin-left: 113pt;\">\n Previously took ARVs as treatment, but not currently taking ARVs :</p>\n</div>\n<p>\n  </p>\n<div>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n ·    Must have been off treatment ≥ 4 weeks</p>\n <p>\n  </p>\n <p style=\"margin-left: 151.35pt;\">\n OR</p>\n <p>\n  </p>\n <p align=\"center\" style=\"margin-left: 111.2pt;\">\n -    Currently taking ARVs for treatment but failing:</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n ·    Must be on an unchanged, failing therapeutic regimen within the 4 to</p>\n <p style=\"margin-left: 167.05pt;\">\n 12 weeks prior to screening (≤1 log drop in HIV-1 RNA within the 4 to 12 weeks prior to screening).</p>\n <p>\n  </p>\n <p style=\"margin-left: 149.05pt;\">\n NOTE: Dose adjustments for growth or formula substitutions (i.e. switching from single agent to fixed dose combination) are permitted during this 4 to 12 week period. Substitutions of one ARV within the same class for toxicity or tolerability management, or discontinuation of ARVs are also allowed within the 4 to 12 weeks period.</p>\n <p>\n  </p>\n <p align=\"center\" style=\"margin-left: 165.2pt;\">\n OR</p>\n <p>\n  </p>\n <p style=\"margin-left: 131pt;\">\n -    For subjects < 2 years of age, initiated ARVs for treatment < 4 weeks prior to screening.</p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n 4.1.3.2  ARV treatment naive (no exposure to ARVs for treatment; could have received</p>\n <p style=\"margin-left: 113pt;\">\n ARVs for prophylaxis or PMTCT)</p>\n <p style=\"margin-left: 149.05pt;\">\n ·    Age < 2 years</p>\n <p>\n  </p>\n <p style=\"margin-left: 89pt;\">\n 4.1.4        If an infant has received NVP as prophylaxis to prevent mother to child transmission (PMTCT), he or she must have <strong>not </strong>received NVP for at least 14 days prior to enrollment into Stage I or II.</p>\n <p>\n  </p>\n <p align=\"center\" style=\"margin-left: 39.2pt;\">\n 4.1.5    HIV-1 RNA viral load greater than 1,000 copies/mL of plasma at screening</p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n NOTE: For subjects enrolling into cohorts IV, IV-DT, V, and V-DT, the HIV RNA test performed at screening may be pending at the time of enrollment. If the screening HIV RNA is ≤ 1000 c/mL, the subject should discontinue study drug, per Section 6.6 and be followed per Appendix IF.</p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n 4.1.6     Demonstrated ability or willingness to swallow assigned study medications. NOTE: Film coated tablets MAY NOT be crushed or dissolved. Dispersible tablets MAY NOT be cut and must be used in five milligram intervals.</p>\n <p>\n  </p>\n <p align=\"center\" style=\"margin-left: 39.2pt;\">\n 4.1.7    Parent or legal guardian able and willing to provide signed informed consent.</p>\n <p>\n  </p>\n <p style=\"margin-left: 77pt;\">\n 4.1.8    Female subjects who are of child bearing potential and who are engaging in sexual activity that could lead to pregnancy, must use two adequate birth control methods while on study and for two weeks after stopping study drug. Hormonal birth control alone (e.g., pills, shots, or slow release inserts placed under/on the skin) would not be considered adequate. An effective, medically accepted barrier method of contraception (e.g., female/male condoms, diaphragm or cervical cap with a cream or gel that kills sperm (excluding nonoxydyl-9), intrauterine device [IUD], others) also must be used during the</p>\n</div>\n<p>\n  </p>\n<p style=\"margin-left: 77pt;\">\n study. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.</p>\n<p>\n  </p>\n<p style=\"margin-left: 72.6pt;\">\n 4.1.9   Males engaging in sexual activity that could lead to HIV-1 transmission must use a condom.</p>\n<p>\n  </p>\n<p style=\"margin-left: 41pt;\">\n 4.1.10 Optimized background therapy (OBT):</p>\n<p>\n  </p>\n<p style=\"margin-left: 90.6pt;\">\n ·    Subjects aged ≥2 years of age (Cohorts I, II, III, and III-DT) must have available at least one fully active drug for the OBT to enroll. Historical genotypes obtained within 1 year of screening will be considered by the Protocol Team for determination of fully active drugs if screening genotype testing is inconclusive.</p>\n<p style=\"margin-left: 90.6pt;\">\n ·    Subjects < 2 years of age (Cohorts IV, IV-DT, V, and V-DT) can enroll if genotype testing has been obtained with results pending.</p>\n<p>\n  </p>\n<p style=\"margin-left: 90.6pt;\">\n Note: Subjects enrolled with genotype results pending but found to have no active drugs per genotype performed at screening should discontinue study drug, per Section</p>\n<p style=\"margin-left: 90.6pt;\">\n 6.6 and be followed per Appendix IF. However, such subjects who have a > 1 log drop in HIV RNA by 4 weeks can continue study drug with approval by the Protocol Team.</p>\n
      • principal_exclusion_criteria<div>\n <p style=\"margin-left: 5pt;\">\n <strong>4.2       Exclusion Criteria</strong></p>\n <p>\n  </p>\n <p>\n  </p>\n <p style=\"margin-left: 36.6pt;\">\n 4.2.1    Presence of any active AIDS defining opportunistic infection</p>\n <p>\n  </p>\n <p style=\"margin-left: 36.6pt;\">\n 4.2.2    At enrollment, subject < 3.0 kg</p>\n <p>\n  </p>\n <p style=\"margin-left: 72.6pt;\">\n 4.2.3    Known ≥ Grade 3 of any of the following laboratory toxicities within 30 days prior to study entry: neutrophil count, hemoglobin, platelets, AST, ALT, lipase, serum creatinine and total bilirubin. A single repeat within the 30 days is allowed for eligibility determination. NOTE: ≥ Grade 3 total bilirubin is allowable, if the subject is on ATV.</p>\n <p>\n  </p>\n <p style=\"margin-left: 72.6pt;\">\n 4.2.4    ANY known Grade 4 laboratory toxicities within 30 days prior to study entry. NOTE: Grade 4 total bilirubin is allowable, if the subject is on ATV.</p>\n <p>\n  </p>\n <p style=\"margin-left: 36.6pt;\">\n 4.2.5    The following liver toxicities within 30 days prior to study entry: ALT > 3x ULN <u>AND</u></p>\n <p style=\"margin-left: 72.6pt;\">\n direct bilirubin is > 2x ULN</p>\n <p>\n  </p>\n <p style=\"margin-left: 72.6pt;\">\n 4.2.6    Any prior history of malignancy, with the exception of localized malignancies such as squamous cell or basal cell carcinoma of the skin</p>\n <p>\n  </p>\n <p style=\"margin-left: 36.6pt;\">\n 4.2.7    Clinical or symptomatic evidence of pancreatitis, as determined by the clinician</p>\n <p>\n  </p>\n <p style=\"margin-left: 72.6pt;\">\n 4.2.8    Use of any disallowed medications at time of screening (see Section 4.3.2 for a complete list of disallowed medications)</p>\n <p>\n  </p>\n <p style=\"margin-left: 36.6pt;\">\n 4.2.9    Known history of exposure to integrase inhibitor treatment by the subject or subject’s</p>\n <p style=\"margin-left: 72.6pt;\">\n mother prior to delivery/cessation of breast feeding</p>\n <p>\n  </p>\n <p style=\"margin-left: 36.6pt;\">\n 4.2.10   Known resistance to an integrase inhibitor</p>\n</div>\n<p>\n  </p>\n<p style=\"margin-left: 36.6pt;\">\n 4.2.11   Women who are pregnant or breastfeeding.</p>\n<p>\n  </p>\n<p style=\"margin-left: 72.6pt;\">\n 4.2.12   Subject is currently participating in or has participated in a study with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from both Protocol Teams is granted</p>\n<p>\n  </p>\n<p style=\"margin-left: 72.6pt;\">\n 4.2.13   Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study to a non-IMPAACT study site</p>\n<p>\n  </p>\n<p style=\"margin-left: 72.6pt;\">\n 4.2.14   Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator’s opinion, would compromise the outcome of this study</p>\n<p>\n  </p>\n<p style=\"margin-left: 72.6pt;\">\n 4.2.15   Subject has used, or anticipates using, chronic systemic immunosuppressive agents or systemic interferon (e.g. for treatment of HCV infection) within 30 days prior to beginning DTG study treatment. Systemic corticosteroids (e.g. prednisone or equivalent up to 2 mg/kg/day) for replacement therapy or short courses (≤30 days) are permitted. (See disallowed medications Section 4.3.2)</p>\n<p>\n  </p>\n<p style=\"margin-left: 72.6pt;\">\n 4.2.16   Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.</p>\n<p>\n  </p>\n<p style=\"margin-left: 72.6pt;\">\n 4.2.17   Active TB disease and/or requirement for treatment that includes rifampin at the time of the screening visit. However, subjects who need rifampin treatment while on DTG will be allowed to continue in P1093 provided the DTG dose is adjusted according to Section</p>\n<p style=\"margin-left: 72.6pt;\">\n 6.1.8.</p>\n
      • primary_end_points<p style=\"margin-left: 41pt;\">\n 8.2.1    Primary Endpoints:</p>\n<p>\n  </p>\n<p style=\"margin-left: 77pt;\">\n 8.2.1.1  Toxicity through Week 24</p>\n<p style=\"margin-left: 113pt;\">\n ·    All adverse events or lab toxicities of Grade 3 or higher severity</p>\n<p style=\"margin-left: 131pt;\">\n ·    Adverse events or lab toxicities of Grade 3 or higher severity judged to be at least possibly attributable to the study medication</p>\n<p style=\"margin-left: 113pt;\">\n ·    Termination from treatment due to a drug-related adverse event</p>\n<p style=\"margin-left: 113pt;\">\n ·    Death</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • 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_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n See the SSA APPEDIX 1 WHICH STATES THE KEMRI /WRP CRC ROLES OF STUDY PERSONNEL</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n Walter Reed Army Institute of Research IRB approved through letter dated: Aug 10 2016</p>\n<p>\n KEMRI SERU approved through letter dated: Aug 18 2016</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration After been on study for 48 weeks, all participants shall enter long term followup phase for 3 years.
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKENYA MEDICAL RESEARCH INSTITUTE/WALTER REED PROJECT HIV PROGRAME
      • single_site_physical_addressHospital Road P.O Box 1357 - 20200 Kericho
      • single_site_contact_personLucy Koech
      • single_site_telephone254522030686
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites
      • multi_country_listKenya, USA, Haiti, Thailand, South Africa
      • data_monitoring_committeeYes
      • total_enrolment_per_site20
      • total_participants_worldwide100
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifychildren
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameWinnie
      • investigator1_middle_name
      • investigator1_family_nameKeter
      • investigator1_qualificationclinical officer
      • investigator1_professional_address1357
      • investigator1_telephone0522030686
      • investigator1_emailwinnie.keter@usamru-k.org
      • organisations_transferred_Yes
      • number_participants20
      • notification
      • approval_date28-03-2017
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-02-10 11:30:49
      • created2016-09-15 15:01:46
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id358
        • application_id556
        • given_nameLucy
        • middle_name
        • family_nameKoech
        • qualificationMBCHB
        • professional_address1357
        • telephone0522030686
        • emaillucy.koech@usamru-k.org
        • created2016-09-16 12:06:16
        • modified2020-03-02 14:32:58
    • SiteDetail(array)
      • 0(array)
        • id433
        • application_id556
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-09-16 12:06:16
        • modified2020-03-02 14:32:58
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id286
        • application_id556
        • sponsorNational Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_personEllen Townley
        • addressMaternal Adolescent Pediatric Branch HJF DAIDS, DAIDS/NIAD/NIH 5601 Fischers Lane Room 8B37
        • telephone_number2402924784
        • fax_number2406273465
        • cell_number2402924784
        • email_addressellen.townley@nih.gov
        • created2016-09-16 12:06:16
        • modified2020-03-02 14:32:58
  • 3(array)
    • Application(array)
      • id92
      • user_id613
      • trial_status_id5
      • abstract_of_study<p>\n Areas of high HIV prevalence and intense malaria transmission significantly overlap especially sub-Saharan Africa where a majority of HIV-infected individuals also live in malaria-endemic regions.  Sub-Saharan Africa remains the region most heavily affected by HIV, accounting for 67% of all people living with HIV and 75% of AIDS deaths in 2007.  Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children, in sub-Saharan Africa.                                           </p>\n<p>\n Recent studies have indicated that the interaction between HIV and malaria infection is bi-directional and synergistic. HIV-infected persons are at increased risk for clinical malaria and potential malaria treatment failure. In addition to an apparent increased vulnerability to malaria parasitemia in HIV-infected adults living in malaria endemic regions, malaria may also enhance HIV replication.  Evidence suggests that HIV/malaria coinfection is associated with increased HIV viral load and may therefore impact negatively upon HIV disease progression and/or increase the risk of HIV transmission.  In Kenya, the burden of both HIV and malaria remains significant.  However, while clinic programs and research studies are ongoing targeting HIV and malaria separately, very little if any research is ongoing focusing upon the HIV/malaria co-infection.</p>\n<p>\n Methods used to prevent the spread of malaria disease endemic areas include prophylactic drugs, mosquito eradication, and the prevention of mosquito bites. Attention to non-traditional malaria therapies that may have antimalarial effects is ongoing given the magnitude of malaria related morbidity and mortality.  Identifying drugs, such as PIs used in the treatment of HIV/AIDS (which are becoming more available in sub-Saharan Africa), with antimalarial activity will provide additional tools in comprehensive malaria control and prevention programs.</p>\n<p>\n This study will test the superiority of LPV/r-based ART compared with nNRTI-based ART clearance of <em>Pf</em> SCP.  The primary endpoint is PCR defined clearance of <em>Pf</em> parasitemia on three consecutive occasions within a 24-hour period. HIV-infected participants ≥18 years with CD4+ counts >200 and <u><</u>350 cells/mm³ who will be starting ART and have <em>Pf</em> SCP will be enrolled and randomized to receive either LPV/r or nNRTI-based ART for 15 days. After the 15 day <em>Pf</em> SCP clearance evaluation, all participants will receive nNRTI-based ART plus TMP/SMX prophylaxis to take for 15 days.</p>\n<p>\n The Kericho site will recruit about 20-30 participants, in part dependent upon timing of protocol activation compared to the other 5 sites in this international, multi-center study.  Recruitment will be focused at the Kericho District Hospital HIV clinic.  Nearby health and HIV Testing and Counseling (HTC) facilities under the KEMRI/WRP PEPFAR program will also be utilized.  Participants will be followed for 30 days. The site accrual rate is estimated to be 2-3 participants per month; hence estimated duration of accrual is about 12 months.</p>\n<p>\n  </p>\n<p>\n If PIs are shown to have marked benefit in clearance of subclinical malaria, such information would be informative to both clinical researchers (i.e. KEMRI) in considering future HIV/malaria infection research as well as policy stakeholders (i.e. Ministry of Health) in considering optimal treatment and prevention initiatives.</p>\n
      • study_title<p align=\"center\">\n  </p>\n<p style=\"text-align: justify;\">\n <strong>An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of </strong></p>\n<p style=\"text-align: justify;\">\n <strong><em>Plasmodium falciparum</em></strong><strong> Subclinical Parasitemia in HIV-infected Adults with CD4+ Counts >200 and <u><</u>350 cells/mm³</strong> .</p>\n
      • laymans_summary<p>\n The areas that has highest problems of HIV infection, also experiences the biggest burden of malaria. Sub-Saharan Africa remains the region most heavily affected by HIV.  Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children, in sub-Saharan Africa. Methods used to prevent the spread of malaria disease endemic areas include prophylactic drugs, mosquito eradication, and the prevention of mosquito bites. Attention to non-traditional malaria therapies that may have antimalarial effects is ongoing given the magnitude of malaria related morbidity and mortality.  Identifying drugs, such as those used in the treatment of HIV/AIDS (which are becoming more available in sub-Saharan Africa), with antimalarial activity will provide additional tools in comprehensive malaria control and prevention programs</p>\n
      • short_titleHIV-Malaria Study_A5297
      • protocol_noECCT/13/04/03
      • version_noVersion 1.0
      • date_of_protocol29-02-2012
      • study_drugefavirenz (EFV), nevirapine (NVP), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/r), and trimethoprim/sulfamethoxazole (TMP/SMX) DS.
      • disease_conditionHIV and Malaria
      • 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_nameefavirenz (EFV), nevirapine (NVP), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), lopinavir/ritonavir (LPV/r), and trimethoprim/sulfamethoxazole (TMP/SMX) DS.
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjosphat.kosgei@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKEMRI Walter Reed Project. P.O. Box 1357-20200 Kericho
      • declaration_date108-04-2013
      • declaration_principal_investigatorDr Josphat Kiprop Kosgei, Principal Investigator.
      • declaration_date208-04-2013
      • placebo_presentNo
      • study_objectives<div>\n Primary Objective</div>\n<div>\n To compare the proportions of Pf SCP clearance between LPV/r-based and</div>\n<div>\n nNRTI based ART in participants after 15 days of therapy (Step 1).</div>\n<div>\n 1.4 Secondary Objectives</div>\n<div>\n 1.4.1 To compare time to Pf SCP clearance in participants with Pf SCP who have</div>\n<div>\n received 15 days of LPV/r-based and nNRTI-based ART.</div>\n<div>\n 1.4.2 To compare Pf parasite densities in participants with Pf SCP who have received</div>\n<div>\n 15 days of LPV/r-based and nNRTI-based ART.</div>\n<div>\n 1.4.3 To estimate changes in Pf parasite densities from day 1 to day 30 in four cohorts:</div>\n<div>\n (1) randomized to nNRTI-based ART with continued Pf SCP at day 15, (2)</div>\n<div>\n randomized to nNRTI-based ART with clearance of Pf SCP at day 15, (3)</div>\n
      • principal_inclusion_criteria<p style=\"margin-left: 1in;\">\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n Note: The term “licensed” refers to a US FDA-approved kit, which is required for all US sites and recommended for non-US ones. For non-US sites that are unable to obtain an FDA-approved kit, a kit that has been certified or licensed by an oversight body within that country and validated internally is acceptable.</p>\n<p style=\"margin-left: 1.5in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n WHO (World Health Organization) and CDC (Center for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n CD4+ count > 200 and <u><</u> 350 cells/mm³ obtained within 30 days prior to study entry at a DAIDS-approved laboratory.</p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n <em>Pf</em> SCP confirmed in a laboratory approved to conduct parasitemia microscopy.</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1in;\">\n Note: <em>Pf</em> SCP will be defined as meeting all three of the following criteria within 72 hours prior to study entry:</p>\n<p style=\"margin-left: 1in;\">\n  </p>\n<p style=\"margin-left: 1.6in;\">\n Microscopy confirmed parasitemia (see section 6.3.6 and the A5297 Manual of Procedures [MOPS])</p>\n<p style=\"margin-left: 1.6in;\">\n  </p>\n<p style=\"margin-left: 1.6in;\">\n An oral temperature <u><</u> 37.5^°C temperature</p>\n
      • principal_exclusion_criteria<p>\n Previous history or current use of ART. </p>\n<p>\n  </p>\n<p>\n Single dose NVP or dual therapies used for PMTCT within 2 years prior to entry.</p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n Use of any medication with antimalarial activity, including TMP/SMX (see list of prohibited medications in the A5297 MOPS), within 14 days prior to study entry. </p>\n<p>\n  </p>\n<p style=\"margin-left: 1in;\">\n Confirmed or clinically suspected OIs (including but not limited to tuberculosis, clinical malaria, <em>PCP</em>), or other pulmonary or gastrointestinal infections for which potential participants did not complete treatment more than 30 days prior to enrollment or have signs and symptoms during screening.</p>\n
      • primary_end_points<p>\n The primary endpoint is PCR defined clearance of <em>Pf</em> parasitemia defined as < 10 parasites/µL on three consecutive occasions within a 24-hour period.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyProof of Concept
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<h1>\n 1SITE INVESTIGATORS AND CONTACT INFORMATION</h1>\n<p>\n  </p>\n<p>\n <strong>A) Site Principal Investigator</strong></p>\n<p>\n Dr Josphat K Kosgei, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 729 110122</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: josphat.kosgei@usamru-k.org</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>B) Associate Investigators</strong></p>\n<p>\n Dr Fredrick K Kirui, MBBS, MPH, MMed</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531 373</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">fredrick.kirui@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n Dr Deborah C Langat, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 714 059596</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">deborah.langat@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Dr Kathleen C. Rono, MBChB, MPH & TM</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">krono@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Dr Lucy Koech, MBChB,</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 719 193275</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">lucy.</a>koech@usamru-k.org</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n Dr Fredrick K. Sawe, MBChB, MMED</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 724 255623</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:fsawe@wrp-kch.org\">fsawe@wrp-kch.org, fsawe@hivresearch.org</a></p>\n<p>\n  </p>\n<p>\n Dr Douglas N. Shaffer, MD, MHS</p>\n<p>\n United States Army Medical Research Unit-Kenya</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555535</p>\n<p>\n Fax: +254 52 30662/+254 52 30546</p>\n<p>\n  </p>\n<p>\n <strong>C) Pharmacist</strong></p>\n<p>\n Dr. Noah K. Tarus, B Pharm, MSc</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 30388</p>\n<p>\n Mobile: +254 713 603222</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:ntarus@wrp-kch.org\">noah.tarus@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n <strong>D) Laboratory Director</strong></p>\n<p>\n Dr Kibet Shikuku, MBChB, MMed</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 716 555537</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">kibet.shikuku@usamru-k.org</a></p>\n<p>\n <strong>E) Data Manager</strong></p>\n<p>\n Ignatius Kiptoo</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O. Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686/+254 52 30388</p>\n<p>\n Mobile: +254 727 531375</p>\n<p>\n Fax: +254 52 30662/+254 52 30546.</p>\n<p>\n Email: <a href=\"mailto:jkosgei@wrp-kch.org\">ignatius.kiptoo@usamru-k.org</a></p>\n<p>\n  </p>\n<p>\n <strong>F) Study Coordinator</strong></p>\n<p>\n Hellen Ngeno, BSN</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 713 603225</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:hngeno@wrp-kch.org\">hngeno@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n <strong>G) Local DoD Research  Monitor</strong></p>\n<p>\n <u>Primary DoD Research Monitor</u></p>\n<p>\n  </p>\n<p>\n Dr. Appolonia Aoko, MBChB</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 715 551234</p>\n<p>\n Fax: +254 52 30662 / +254 52 30546</p>\n<p>\n Email: <a href=\"mailto:aaoko@wrp-kch.org\">aaoko@wrp-kch.org</a></p>\n<p>\n  </p>\n<p>\n Alternate DoD Research Monitor</p>\n<p>\n  </p>\n<p>\n Dr. Jonah Maswai, MBChB, MPH</p>\n<p>\n Kenya Medical Research Institute/Walter Reed Project</p>\n<p>\n HIV Program</p>\n<p>\n P.O Box 1357 – 20200,</p>\n<p>\n Hospital Road, Kericho, Kenya</p>\n<p>\n Tel: +254 52 30686 / +254 52 30388</p>\n<p>\n Mobile: +254 716 430271</p>\n
      • other_details_explanation<p>\n Kenya has a high prevalence of both HIV and Malaria, which is a requirement of the study.</p>\n
      • other_details_regulatory_notapproved<p>\n None.</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute (KEMRI) Ethical Research Committee. Approval date 26 March 2013. This is for Kericho site only.</p>\n
      • other_details_regulatory_rejected<p>\n None.</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable.</p>\n
      • estimated_durationOne year
      • 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_comparatorNNRTI arm
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites2
      • multi_country_listKenya, Botswana, Malawi, India
      • data_monitoring_committeeYes
      • total_enrolment_per_site20-30
      • total_participants_worldwide52
      • 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_nameDavid
      • investigator1_middle_nameC.
      • investigator1_family_nameWekulo
      • investigator1_qualificationBScN
      • investigator1_professional_addressKEMRI WRP P.O. Box 1357-20200 Kericho
      • investigator1_telephone254729110146
      • investigator1_emaildavid.wekulo@usamru-k.org
      • organisations_transferred_Yes
      • number_participants20-30
      • notification
      • approval_date26-03-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<div>\n A5297 is a phase I/II, open-label, proof of concept, two-step, two-arm, controlled randomized clinical trial (RCT) to</div>\n<div>\n test the superiority of lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) to nonnucleoside reverse</div>\n<div>\n transcriptase (nNRTI)-based ART for clearance of Plasmodium falciparum (Pf) subclinical parasitemia (SCP).</div>\n<div>\n Participants were followed for 30 days in order to evaluate parasitemia clearance, Pf parasitemia, gametocytemia,</div>\n<div>\n and plasmepsin sequencing. Participants will have blood collected twice at entry, day 3, 6, 9, 12, 20, and 25 and</div>\n<div>\n three times for day 15 and day 30.</div>\n<div>\n Fifty-two participants (26 per arm) enrolled between January 10, 2014 and May 20, 2016 with 46 (88%) from two</div>\n<div>\n sites in Kenya. Fifty-one participants completed the primary outcome (Step 1) visit, and 49 completed the protocol</div>\n<div>\n as specified. The study population was mostly male (67%) with a median age of 31 (Q1, Q3=24, 39) years. The</div>\n<div>\n median baseline CD4 count was 324 cells/mm3 (259, 404) and median baseline log10 (HIV-1 RNA) was 5.18</div>\n<div>\n copies/mL (4.60, 5.71). The median baseline parasite density was 2.66 log10 parasites/μL (1.92, 3.35) (Table 1).</div>\n<div>\n For the primary outcome, there was no statistically significant difference in clearance between the LPV/r-based</div>\n<div>\n (n=6, 23%) and nNRTI-based (7, 27%) ART arms (Table 2). Sensitivity analyses were conducted around missing data:</div>\n<div>\n one where missing data were assumed to have cleared and one where missing data were excluded. Sensitivity</div>\n<div>\n analyses were also conducted using less stringent definitions of clearance: one where participants were considered</div>\n<div>\n cleared if any 2 of 3 samples had <10 estimated parasites/μL at day 15 by qRT-PCR and one where participants</div>\n<div>\n were considered cleared if any 1 of 3 samples had < 10 parasites/μL at day 15 by qRT-PCR. In all sensitivity</div>\n<div>\n analyses, the difference in clearance between the treatment arms remained non-significant.</div>\n<div>\n Secondary objective analyses included time-to–Pf parasite clearance, between-arm parasite densities over time,</div>\n<div>\n and safety outcomes. No statistically significant differences in time-to-Pf 9 parasite clearance were observed</div>\n<div>\n between arms (P=0.80, Figure 2). Mean Pf parasite densities through the 30-day study window were examined</div>\n<div>\n (Figure 3). While overall, a trend was observed in decreasing Pf parasite densities in both arms throughout the</div>\n<div>\n study, there was no difference between the two treatment arms during days 1-15 (LPV/r Arm median = -0.61 [Q1,</div>\n<div>\n Q3 = -1.78,0.00] and nNRTI Arm -0.46 [-1.31,0.41]) or days 15-30 (LPV/r Arm -1.04 [-2.39,-0.67] and nNRTI Arm -</div>\n<div>\n 1.40 [-2.51,-0.52]). Overall, Pf parasite density decreased between entry and day 30 (-2.36 [-3.46,-0.94]); at the</div>\n<div>\n same time median CD4 counts increased (101 cells/mm3) and median log10 HIV RNA decreased (-2.48 copies/mL)</div>\n<div>\n with no significant between arm differences.</div>\n<div>\n During the study period, there were few adverse events with no hospitalizations. Three cases of uncomplicated,</div>\n<div>\n Grade 2 clinical malaria (LPV/r Arm n=2, nNRTI Arm n=1) occurred during Step 1, and all received SOC</div>\n<div>\n artemether/lumefantrine. One participant in both treatment arms experienced Grade 2 anemia (n=2).</div>\n<div>\n The Study’s results did not find a statistically significant difference in parasite clearance rates nor in time-toparasite</div>\n<div>\n clearance between PI and nNRTI treatment arms. To the Study’s knowledge, the proof-of-concept RCT of</div>\n<div>\n HIV-infected adults beginning first-line ART with Pf SCP is the first direct comparison between a PI (LPV/r) and</div>\n<div>\n nNRTI.</div>\n
      • implication_results<div>\n Yes, from the Primary Manuscript:</div>\n<div>\n  The Study’s results did not find a statistically significant difference in parasite clearance rates</div>\n<div>\n nor in time-to-parasite clearance between PI and nNRTI treatment arms. To the Study’s knowledge, the</div>\n<div>\n proof-of-concept RCT of HIV-infected adults beginning first-line ART with Pf SCP is the first direct</div>\n<div>\n comparison between a PI (LPV/r) and nNRTI.</div>\n<div>\n  The Study provides a unique cohort testing the clinical impact of PIs in a setting without and with</div>\n<div>\n TMP/SMX. While participants had CD4 counts >200 given requirements for TMP/SMX in people with lower</div>\n<div>\n CD4 counts, the Study observed no complicated malaria, PCP, or diarrheal disease.</div>\n<div>\n  Three cases of uncomplicated malaria (parasitemia and fever) during the first 15 days in the absence of</div>\n<div>\n TMP/SMX. This likely reflects fluctuations in SCP in the absence of TMP/SMX and occasional fever</div>\n<div>\n threshold densities being passed.</div>\n<div>\n  This Study also provides unique opportunity for further investigation into parasite and gametocyte life</div>\n<div>\n cycles and kinetics.</div>\n
      • quantity_importedFind attached product accountability documents
      • quantity_dispensedFind attached product accountability documents
      • quantity_destroyedFind attached product accountability documents
      • quantity_exportedFind attached product accountability documents
      • balance_siteFind attached product accountability documents
      • final_date0000-00-00
      • modified2025-02-25 13:18:04
      • created2013-04-04 14:58:19
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id60
        • application_id92
        • given_nameJosphat
        • middle_nameK.
        • family_nameKosgei
        • qualificationMBChB
        • professional_addressKEMRI WRP P.O. Box 1357-20200 Kericho
        • telephone254729110122
        • emailjosphat.kosgei@usamru-k.org
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
    • SiteDetail(array)
      • 0(array)
        • id80
        • application_id92
        • county_id35
        • site_nameKemri Walter Reed Project-Kericho
        • physical_addressHospital road
        • contact_detailsP.O. Box 1357-20200
        • contact_personJosphat Kosgei
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id83
        • application_id92
        • county_id27
        • site_nameMoi University Clinical Research Centre
        • physical_addressMoi Teaching Referral Hospital Building, Nandi Road, Eldoret, Kenya
        • contact_detailsP.O. Box 4604 - 30100 Kenya Tel:254-53 2060850
        • contact_personRonald Kibet
        • site_capacity(null)
        • misc(null)
        • created2013-04-04 17:36:47
        • modified2020-03-17 12:04:08
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
    • Sponsor(array)
      • 0(array)
        • id46
        • application_id92
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_personBeverly Alston-Smith, MD
        • address6700 B Rockledge Drive, Room 5109 Bethesda, MD 20892-7605
        • telephone_number301-435-3773
        • fax_number301-480-4582
        • cell_number301-435-3773
        • email_addressbalston@niaid.nih.gov
        • created2013-04-04 15:03:34
        • modified2020-03-17 12:04:08
  • 4(array)
    • Application(array)
      • id1127
      • user_id263
      • trial_status_id5
      • abstract_of_study<p>\n Sickle cell disease (SCD) is a related group of common and rare hemoglobin (Hb) genotypes in which all affected individuals are either homozygotes for the sickle Hb (HbS) mutation of the β-globin subunit or compound heterozygotes for HbS and another globin gene mutation. A hallmark symptom of SCD is a painful Vaso-occlusive crisis (VOC). An interplay of the various pathologic processes in SCD perpetuates and feeds forward an inflammatory priming that, in the presence of a precipitating event, can lead to a VOC. VOCs are responsible for a wide variety of clinical complications of SCD, including pain syndromes, acute chest syndrome (ACS), stroke, priapism, leg ulcers, spontaneous abortion, renal insufficiency, and multiorgan failure leading to death. Frequency of VOCs, along with Absolute Neutrophil count (ACS), is the most common predictor of death in patients with SCD. Thus, early identification, treatment, and prevention of VOCs could significantly impact the natural course of the disease. Interventions for treatment and prevention of longer-term complications are urgently needed.</p>\n<p>\n  </p>\n<p>\n About 240,000 children in Africa, are born each year with Sickle Cell Disease (SCD), while here in Kenya, it is estimated that 6,000 children are born with the disease. Sadly, between 50 to 80 per cent of these children die before their fifth birthday. The recurrent pain and complications caused by the disease, can interfere with many aspects of the patient’s life, including education, employment and psychosocial development.</p>\n
      • study_title<p align=\"center\">\n <strong>A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Characterize the Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients with Sickle Cell Disease</strong></p>\n
      • laymans_summary<p>\n The objective of this study is to understand/characterize the pharmacokinetic/PK (how our bodies affect the drug) and the Pharmacodynamics/PD (meaning how the drug affects our bodies) of a drug called Rifaximin, which is used in treatment of patients with sickle cell disease.</p>\n<p>\n Of the current treatment options available for sickle cell disease, only bone marrow transplant is a permanent cure, but few patients qualify for this treatment. Patients on the other treatment options e.g., hydroxyurea and L glutamine may still experience acute clogging of blood vessels called Vaso Occlusive crisis (VOC) There is a need to find more treatment options for sickle cell disease that prevents the VOC.</p>\n
      • short_titleSickle Cell Disease
      • protocol_noECCT/22/03/06
      • version_noVersion 2.0_16 Aug 2021
      • date_of_protocol16-08-2021
      • study_drugrifaximin ER and DER
      • disease_conditionSickle cell disease
      • 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_namexifaxan
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantMichelle Botha
      • declaration_date120-03-2022
      • declaration_principal_investigatorDr L Tina
      • declaration_date220-03-2022
      • placebo_presentYes
      • study_objectives<p>\n The objectives of this study are: To characterize the pharmacokinetics/pharmacodynamics (PK/PD) of rifaximin ER and DER in subjects with sickle cell disease (SCD) and to assess the safety and tolerability of rifaximin (Extended Release) ER and Delayed Extended Release (DER).</p>\n
      • principal_inclusion_criteria<p>\n Participants are eligible for the study only if all the following criteria are met:</p>\n<ol>\n <li>\n Subject must have the ability and willingness to sign a written informed consent form.</li>\n <li>\n Subject is between the ages of 18 to 70 years old (inclusive) at the time of consent.</li>\n <li>\n Subject has SCD of any genotype (HbSS, HbSC, HbS β-thalassemia). If the subject’s genotype has not been previously documented, genotyping will be performed during Screening using high-performance liquid chromatography (HPLC)/electrophoresis.</li>\n <li value=\"4\">\n Subject must have experienced at least 2 VOCs within the 12 months prior to Screening. A VOC is defined as: </li>\n</ol>\n<p>\n                             a. The occurrence of appropriate symptoms consistent with a painful crisis, acute chest syndrome (ACS), or priapism, and</p>\n<p style=\"margin-left: 72pt;\">\n b. Requires a visit to a medical facility and/or healthcare professional, and</p>\n<p style=\"margin-left: 72pt;\">\n c. Receipt of either a parenteral or oral opioid or NSAID analgesia.</p>\n<ol>\n <li value=\"5\">\n If subject is receiving hydroxyurea (HU)/hydroxycarbamide (HC), subject must have been receiving the treatment for at least 6 months prior to Screening and must agree to maintain the same dose and schedule for the duration of the study.</li>\n <li value=\"6\">\n Subjects must have laboratory values at Screening within the following ranges:\n <ul>\n <li>\n Absolute Neutrophil Count ≥1.0 x 109/L</li>\n <li>\n Platelets ≥ 75 x 109/L</li>\n <li>\n Hemoglobin (Hgb) ≥ 6.0 g/dL</li>\n <li>\n Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m2 using the CKD-EPI formula</li>\n <li>\n Direct (conjugated) bilirubin ≤ 2.0 x ULN</li>\n <li>\n Alanine transaminase (ALT) ≤ 3.0 x ULN</li>\n <li>\n International Normalized Ratio (INR) ≤ 2.0</li>\n </ul>\n </li>\n <li value=\"7\">\n Eastern Cooperate Oncology Group (ECOG) performance status ≤ 2.</li>\n <li value=\"8\">\n Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at Screening and agree to use standard prevention methods for the duration of the study.</li>\n</ol>\n
      • principal_exclusion_criteria<p>\n Participants are not eligible for inclusion for the trial if any of the following criteria are met:</p>\n<ol>\n <li>\n Subject is receiving concomitant treatment with voxelotor, crizanlizumab, or L-glutamine.</li>\n <li>\n Subject has any history of stem cell transplant is planning to begin or has received in the past 30 days.</li>\n <li value=\"3\">\n Subject experiences an acute VOC, requiring a visit to a medical facility and/or healthcare professional, ending within 7 days prior to Day 1 dosing.</li>\n <li value=\"4\">\n Subject has received any blood products within 30 days of Day 1 dosing.</li>\n <li value=\"5\">\n Subject has uncontrolled liver disease or renal impairment, ulcerative colitis, Crohn’s disease, or other chronic GI disorder.</li>\n <li value=\"6\">\n Subject has received active treatment in another investigational trial within 30 days or 5 half-lives of the last dose of the investigational agent, whichever is greater, prior to Screening.</li>\n <li value=\"7\">\n Subject has received penicillin prophylaxis or antibiotics for treatment of infection within 30 days or 5 half-lives of the treatment, whichever is greater, prior to Screening.</li>\n <li value=\"8\">\n Subject has a significant medical condition that required hospitalization (other than for a VOC) within 2 months prior to Screening.</li>\n <li value=\"9\">\n Subject is planning on undergoing an exchange transfusion during the duration of the study or has completed one within 4 weeks prior to Day 1 dosing.</li>\n <li value=\"10\">\n Subject has a hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any components of rifaximin ER and DER.</li>\n <li value=\"11\">\n Subject has used therapeutic anticoagulation (prophylactic doses are permitted) or antiplatelet therapy (other than aspirin or NSAIDs) within 10 days prior to Day 1 dosing.</li>\n <li value=\"12\">\n Subject is pregnant or a nursing woman.</li>\n <li value=\"13\">\n Subject has a history of illicit drug use or abuse, either documented or in the opinion of the Investigator.</li>\n <li value=\"14\">\n Subject is using any medication that is known to inhibit or induce CYP3A4, P-gp, or OATP1B1/B3 (See Appendix 3) within 30 days or 5 half-lives, whichever is longer, prior to Day 1 dosing, or in the opinion of the Investigator, may affect the evaluation of the study product or place the subject at undue risk.</li>\n <li value=\"15\">\n Subject has had any prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach, or small/large intestine (with the exception of appendectomy, cholecystectomy, and fundoplication).</li>\n <li value=\"16\">\n Subject has had a colonoscopy or sigmoidoscopy within 30 days prior to Day 1 or plans to undergo such a procedure during the duration of the study.</li>\n <li value=\"17\">\n Subject has used bowel prep, laxative, or enema within 30 days prior to Day 1.</li>\n <li value=\"18\">\n Subject has a bleeding disorder including, but not limited to, acquired or congenital platelet function defects, disseminated intravascular coagulation (DIC), bleeding factor deficiencies, hemophilia, idiopathic thrombocytopenia purpura (ITP), or von Willebrand’s disease.</li>\n <li value=\"19\">\n Subject is planning to undergo a major surgical procedure during the duration of the study.</li>\n <li value=\"20\">\n Subject has a positive test for human immunodeficiency virus (HIV)1 or HIV2.</li>\n <li value=\"21\">\n Subject has an active Hepatitis B infection (HBsAg positive). Prior infection that is not active (i.e., HBsAg negative, HBcAb positive, and HBsAb positive) is permitted.</li>\n <li value=\"22\">\n Subject has a positive test for Hepatitis C (HCV RNA). Prior infection with spontaneous resolution or sustained resolution for ≥ 24 weeks after cessation of antivirals is permitted.</li>\n <li value=\"23\">\n Subject has an active COVID-19 infection or complication(s) related to COVID-19 infection that are unresolved or, in the opinion of the Investigator, may affect evaluation of the study drug or place the subject at undue risk.</li>\n <li value=\"24\">\n Subjects has received a vaccine (including COVID-19 vaccine) within 2 weeks prior to Screening. If subject has received their first of two COVID-19 vaccination doses, as applicable, they must wait for at least 2 weeks after receiving the second dose, and be symptom-free, prior to beginning Screening. Subject must not be planning for COVID-19 or other vaccinations while on study.</li>\n <li value=\"25\">\n Subject has a malignant disease. Exceptions include malignancies that were treated curatively and have not recurred within 2 years prior to study treatment, completely resected basal cell and squamous cell skin cancers, and any completely resected carcinoma in situ.</li>\n <li value=\"26\">\n Subjects has prolonged QT interval as assessed by ECG history within the past 3 months. For subjects with no historical ECG information, subject has a resting QTcF ≥ 460 msec for males and ≥ 470 msec for females at Screening.</li>\n <li value=\"27\">\n Subject has any unstable cardiac condition that, in the opinion of the Investigator, may worsen during the study or interfere with successful evaluation of the study treatment.</li>\n <li value=\"28\">\n Subject has a serious mental or physical illness which, in the opinion of the Investigator, would compromise participation in the study.</li>\n <li value=\"29\">\n Subject has any condition which, in the opinion of the Investigator, is likely to interfere with the successful collection of the measurements required for the study.</li>\n</ol>\n
      • primary_end_points<p>\n Full rifaximin and 25-desacetyl rifaximin plasma PK profiles following administration on Days 1 and 29 and C_max and C_trough on Days 8, 15, and 29 will be evaluated at specified timepoints according to the schedule of activities.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 1. Victoria Biomedical Research Institute (VIBRI) (PI:  LO Tina):</p>\n<p>\n VIBRI is a non-profit providing pharmaceutical, academic research and non-profit organization with a network of clinical sites and expertise focusing on accelerating transformative therapeutics, vaccines, and devices research for major gloabl health diseases in Kenya.  VIBRI is located at the Kisumu County Referral Hospital in Kisumu County, western Kenya.  VIBRI was established to conduct biomedical research including clinical trials, bioequivalence studies, basic science research studies, epidemiology and population health studies, implementation science studies, build a strong doundation in data science, conduct training and capacity building on clinical research in Kenya.  VIBRI has experienced and accomplished clinical research scientists who have designed and conducted GCP compliance phase 1b to phase IV paediatric and adult clinical trials.  </p>\n<p>\n 2. CREATES (PI:  Dr Bernhards Ogutu):</p>\n<p>\n The KUTRH is designed for clinical trials with a bed space of 600 and ICU beds of 25.  It is a referral healthcare facility experienced in clinical trials. The PI is support by a large team of experienced Sub Investigators and SSCs.  Along with experienced pharmacists to manage the IP.  The site has ample well-equipped clinical laboratories, radiological services and ample clinical observation areas as well as spacious research operations office.</p>\n<p>\n 3. International Cancer Institute (PI:  Prof. FC Asirwa):</p>\n<p align=\"left\" style=\"margin-left:.45pt;\">\n The study will be conducted at the International Cancer Institute (ICI) in Eldoret, Kenya. Recruitment will occur at the research and care clinic located along Nandi Road. ICI research and care clinic is staffed by qualified research personnel including 1 Medical Oncologist, 1 Clinical Oncologist, 4 medical officers, 1 Pharmacist, 1 pharmaceutical Technologist, 1 clinical officer, 4 nurses,1 consultant pathologist, 2 laboratory technologists, 1 patient navigator and 1 administrator. ICI has a research and molecular diagnostics laboratory, for sample testing and storage. The site has a registration area, consultation rooms, examination rooms, chemotherapy administration area, records and data storage, pharmacy and laboratory. International Cancer Institute currently runs a clinic where patients with SCD from Uasin Gishu County and different parts of the Country are managed. The site participates in several other Randomized controlled trials with key focus on Haemato-oncology trials.</p>\n<p>\n 4. KEMRI/USAMRD-K Kombewa Clinical Research Center (PI: Janet Oyieko)</p>\n<div>\n The KEMRI/WRP Kombewa Clinical Research Center (KCRC) is designed for large clinical</div>\n<div>\n trials and has a full clinical laboratory including microbiology capability.</div>\n<div>\n KCRC is part of The Walter Reed Project (WRP), which is a 40-year collaboration between the</div>\n<div>\n Kenya Medical Research Institute, (KEMRI) and the Walter Reed Army Institute of Research</div>\n<div>\n (WRAIR). The US Army Medical Research Unit in Kenya (USAMRU-K) is a WRAIR</div>\n<div>\n attachment stationed in Kenya with headquarters in Nairobi and field stations in Kericho and</div>\n<div>\n Kisumu. WRP-Kisumu conducts a wide spectrum of field and laboratory work including</div>\n<div>\n numerous clinical research trials.</div>\n
      • other_details_explanation<p>\n Study is being conducted in America</p>\n
      • other_details_regulatory_notapproved<p>\n Applications are planned for Egypt and Lebanon</p>\n
      • other_details_regulatory_approved<p>\n US FDA provided approval to proceed on 11 June 2021</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration6 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_countriesYes
      • multiple_member_states2
      • number_of_sites4
      • multi_country_listNorth America\nMiddle east
      • data_monitoring_committeeNo
      • total_enrolment_per_site3-10
      • total_participants_worldwide60
      • 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_nameLucas
      • investigator1_middle_nameOtieno
      • investigator1_family_nameTina
      • investigator1_qualificationMBChB, MSc, DLSHTM
      • investigator1_professional_addressVictoria Biomedical Research Institute
      • investigator1_telephone+254720596654
      • investigator1_emaillucas.tina0818@gamil.com
      • organisations_transferred_Yes
      • number_participants20
      • notification
      • approval_date15-09-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-05-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer comments have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-06-11 12:33:58
      • created2022-03-09 10:16:30
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id799
        • application_id1127
        • given_nameJanet
        • middle_name
        • family_nameOyieko
        • qualificationMBChB, MMED, PhD
        • professional_addressKombewa Clinical Research Centre
        • telephone+254721996988
        • emailjanet.oyieko@gmail.com
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
      • 1(array)
        • id800
        • application_id1127
        • given_nameFredrick
        • middle_nameChite
        • family_nameAsirwa
        • qualificationProf, M.D.
        • professional_addressInternational Cancer Institute (ICI).
        • telephone+254 718 473 446
        • emaildirector@intercancer.com
        • created2022-03-11 10:09:31
        • modified2022-05-09 16:38:41
      • 2(array)
        • id801
        • application_id1127
        • given_nameBernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB, MSc
        • professional_addressCREATES - Strathmore University Medical Centre
        • telephone+254733812613
        • emailogutu6@gmail.com
        • created2022-03-11 10:09:31
        • modified2022-05-09 16:38:41
    • SiteDetail(array)
      • 0(array)
        • id1253
        • application_id1127
        • county_id42
        • site_nameKombewa Clinical Research Centre
        • physical_addressOff Kisumu-Bondo Road, opposite Kombewa county Hospital
        • contact_details+254721996988
        • contact_personDr. Janet Oyieko
        • site_capacity(null)
        • misc(null)
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1254
        • application_id1127
        • county_id42
        • site_nameVictoria Biomedical Research institute
        • physical_addressP.O BOX 7180-40100 KISUMU
        • contact_details+254720597654
        • contact_personDr. Lucas Otieno tina
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1255
        • application_id1127
        • county_id27
        • site_nameInternational Cancer Centre
        • physical_addressNandi road, P.O BOX 8088, Eldoret
        • contact_details+254700522149
        • contact_personDr. Fredrick Asirwa
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 3(array)
        • id1256
        • application_id1127
        • county_id47
        • site_nameCREATES - Strathmore University Medical Centre
        • physical_addressP.O BOX 59857 - 00200 Madaraka Estate, Nairobi
        • contact_details+254733812613
        • contact_personDr. Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2022-03-11 09:22:47
        • modified2022-05-09 16:38:41
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id583
        • application_id1127
        • sponsorSalix Pharmaceuticals, Inc., a division of Bausch Health US, LLC.
        • sponsor_typeIndustry
        • contact_person
        • addressBausch Health US, LLC Bridgewater, NJ 08807 USA
        • telephone_number1-800-321-4576
        • fax_number
        • cell_number 908-927-1400
        • email_addressSean.Humphrey@bauschhealth.com
        • created2022-03-09 11:01:56
        • modified2022-05-09 16:38:41
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_exploratory1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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